6-month Lifestyle Intervention Research Articles

Implementing an evidence-based behavioral weight-loss program in community mental health centers: A randomized pilot study.

Obesity is a leading cause of preventable death among individuals with serious mental illness (SMI). A prior randomized controlled trial demonstrated the efficacy of a lifestyle style intervention tailored to this population; however, such interventions need to be adapted and tested for real-world settings. This study evaluated implementation interventions to support community mental health program staff to deliver an evidence-based lifestyle intervention to clients with obesity and SMI. In this cluster-randomized pilot trial, the standard arm combined multimodal training with organizational strategy meetings and the enhanced arm included all standard strategies plus performance coaching. Staff-coaches delivered a 6-month group-based lifestyle intervention to clients with SMI. Primary outcomes were changes in staff knowledge, self-efficacy, and fidelity scores for lifestyle intervention delivery. Linear mixed-effects modeling was used to analyze outcomes, addressing within-site clustering and within-participant longitudinal correlation of outcomes. Three sites were in the standard arm (7 staff-coaches); 5 sites in the enhanced arm (11 staff-coaches). All sites delivered all 26 modules of the lifestyle intervention. Staff-coaches highly rated the training strategy's acceptability, feasibility and appropriateness. Overall, mean knowledge score significantly increased pre-post by 5.5 (95% CI: 3.9, 7.1) and self-efficacy was unchanged; neither significantly differed between arms. Fidelity ratings remained stable over time and did not differ between arms. Clients with SMI achieved a mean 6-month weight loss of 3.8 kg (95% CI: 1.6, 6.1). Mental health staff delivering a lifestyle intervention was feasible using multicomponent implementation interventions, and preliminary results show weight reduction among clients with SMI. The addition of performance coaching did not significantly change outcomes. Future studies are needed to definitively determine the effect on client health outcomes.

Resumption of ovulation in anovulatory women with PCOS and obesity is associated with reduction of 11β-hydroxyandrostenedione concentrations.

Is resumption of ovulation after a 6-month lifestyle intervention in women with PCOS and obesity associated with differential changes in endocrine and metabolic parameters (weight, insulin resistance, anti-Müllerian hormone (AMH), and androgens) compared to women with PCOS who remained anovulatory? Resumption of ovulation after a 6-month lifestyle intervention in women with PCOS and obesity is associated with changes in serum 11β-hydroxyandrostenedione (11OHA4) concentrations. Lifestyle interventions have been shown to reduce clinical and biochemical hyperandrogenism in women with PCOS. Weight loss of 5-10% may reverse anovulatory status, thereby increasing natural conception rates. However, the mechanisms underlying why some women with PCOS remain anovulatory and others resume ovulation after weight loss are unclear. Reproductive characteristics at baseline and a greater degree of change in endocrine and metabolic features with lifestyle intervention may be crucial for ovulatory response. We used data and samples originating from an earlier randomized controlled trial (RCT), which examined the efficacy of a 6-month lifestyle intervention prior to infertility treatment compared to prompt infertility treatment on live birth rate in women with obesity. A total of 577 women with obesity (BMI > 29 kg/m2) were randomized between 2009 and 2012. Anovulatory women with PCOS who were allocated to the intervention arm of the original RCT (n = 95) were included in the current analysis. We defined women as having resumed ovulation (RO+) based on the following criteria: spontaneous pregnancy; or assignment to expectant management; or IUI in natural cycles as the treatment strategy after lifestyle intervention. Steroid hormones were measured using liquid chromatography tandem mass spectrometry. Generalized estimating equations with adjustment for baseline measures and interaction between group and time was used to examine differences in changes of endocrine and metabolic parameters between RO+ (n = 34) and persistently anovulatory women (RO-, n = 61) at 3 and 6 months after intervention. At baseline, the mean ± SD age was 27.5 ± 3.6 years in the RO+ group and 27.9 ± 4.1 years in the RO- group (P = 0.65), and the mean ± SD weights were 101.2 ± 9.5 kg and 105.0 ± 14.6 kg, respectively (P = 0.13). Baseline AMH concentrations showed significant differences between RO+ and RO- women (median and interquartile range [IQR] 4.7 [3.2; 8.3] versus 7.2 [5.3; 10.8] ng/ml, respectively). Baseline androgen concentrations did not differ between the two groups. During and after lifestyle intervention, both groups showed weight loss; changes in 11OHA4 were significantly different between the RO+ and RO groups (P-value for interaction = 0.03). There was a similar trend for SHBG (interaction P-value = 0.07), and DHEA-S (interaction P-value = 0.06), with the most pronounced differences observed in the first 3 months. Other parameters, such as AMH and FAI, decreased over time but with no difference between the groups. No high-resolution transvaginal ultrasonography was used to confirm ovulatory status at the end of the lifestyle program. The small sample size may limit the robustness of the results. Reduction of androgen concentrations during and after lifestyle intervention is associated with recovery of ovulatory cycles. If our results are confirmed in other studies, androgen concentrations could be monitored during lifestyle intervention to provide individualized recommendations on the timing of resumption of ovulation in anovulatory women with PCOS and obesity. The study was supported by a grant from ZonMw, the Dutch Organization for Health Research and Development (50-50110-96-518). The Department of Obstetrics and Gynecology of the UMCG received an unrestricted educational grant from Ferring Pharmaceuticals BV, The Netherlands. A.H. reports consultancy for the development and implementation of a lifestyle App MyFertiCoach developed by Ferring Pharmaceutical Company. All other authors have no conflicts to declare. The LIFEstyle RCT was registered at the Dutch trial registry (NTR 1530).

Changes in health-related quality of life and sleep habits after a 6-month non-randomised cluster-controlled trial among children with overweight or obesity.

Being overweight or obese can have severe negative psychological impacts and reduce health-related functioning. To improve health-related quality of life (HRQoL) and sleep habits for children with overweight or obesity, it is important to design and implement effective interventions. The aim of this study was to evaluate the effects of a 6-month family-based lifestyle intervention on HRQoL and sleep habits in Norwegian children with overweight or obesity in a primary-care setting. This 6-month, non-randomised, cluster-controlled trial included Norwegian children aged 5-13years with overweight or obesity and their parents. A questionnaire was filled out by the parents. A total of 33 and 52 children in the control group and 41 and 78 children in the intervention group answered the HRQoL and sleep habits questions, respectively, and were included. The intervention group received individual family counselling and participated in physical activity groups and nutrition courses. The Children's Sleep Habits Questionnaire (CSHQ) and Kidscreen-10 index were used to assess sleep habits and HRQoL. At baseline, the mean average scores for HRQoL were 50.0 [standard deviation (SD) 8.1] for the intervention group and 49.0 (SD 10.1) for the control group. For sleep habits at baseline, the mean average scores were 45.2 (SD 11.8) for the intervention group and 46.0 (SD 11.9) for the control group. No significant changes in HRQoL and sleep habits after the intervention were revealed. Overall, the family-based lifestyle intervention targeting overweight and obese children in a primary-care setting showed no significant effect on HRQoL or sleep quality.

Home-based lifestyle intervention for breast cancer survivors: A surprising improvement in the quality of life during the first year of COVID-19 pandemic.

The COVID-19 pandemic induced an extraordinary impact on public mental health to a degree not completely understood, especially in vulnerable populations such as breast cancer (BC) survivors. In this study, we described the short- (after 3-month) and long- (after 12-month) term effects of a multidisciplinary home-based lifestyle intervention in Italian women BC survivors during the first year of COVID-19 pandemic. In total, 30 Italian BC survivors with risk factors for recurrence took part in the ongoing MoviS trial (protocol: NCT04818359). Between January 2020 and January 2021, a 3-month lifestyle intervention based on psychological counseling, nutrition, and exercise was carried out. Participants were asked to fill out psychological questionnaires for the assessment of quality of life (QoL) indicators (European Organization for Research and Treatment of Cancer QoL, EORTC-QLQ-C30) and psychological health measures such as fatigue (Brief Fatigue Inventory, BFI), distress (Distress Thermometer, DT and Psychological Distress Inventory, PDI), cancer-related fatigue (Verbal Rating Scale, VRS), and mood states (Profile of Mood States Questionnaire, POMS). IBM SPSS Statistical Software version 27.0 and R Project for Statistical Computing version 4.2.1 were used to process data. All participants were assessed at four time points: T0 (baseline), T1 (3-month), and follow-up at T2 and T3 (6- and 12-month, respectively) to measure primary (quality of life indicators) and secondary (psychological health) outcomes. Friedman non parametric test and Wilcoxon signed rank test (with Bonferroni correction) were conducted to investigate the statistically significant differences in psychometric scores and between assessment times. Compared to baseline (T0), at T1 most of the QoL indicators (i.e., symptoms of fatigue and general health) were improved (p < 0.017) with the exception of a worsening in participants' social functioning ability. Also, perception of severity of fatigue, distress, cancer-related fatigue, depression, and anger enhanced. Compared to baseline (T0), at T3 we mainly observed a stable condition with T0-T1 pairwise comparison, however other secondary outcomes (i.e., fatigue mood state, confusion, and anxiety) significantly improved. Our preliminary findings support the proposal of this lifestyle intervention for BC survivors. Despite the home-confinement due to the COVID-19 pandemic, the intervention surprisingly improved QoL indicators and psychological health of the participants.

Participation in a multicomponent lifestyle intervention for people with obesity improves glycated hemoglobin (HbA1c).

Obesity is associated with compromised glucose metabolism. Hence, it is of interest to investigate if the lifestyle interventions used in the LIBRA-cohort, which aimed at not only weight loss, but also patient well-being, could also help obese patients improve glucose metabolism by evidence of reduced HbA1c. The aim of the study was to retrospectively investigate if patients who were referred to a lifestyle intervention for obesity, were able to alter HbA1c. Patients with a BMI≥30 undergoing a 6-month lifestyle intervention, who also completed physical and mental health surveys and whose baseline and 6-month blood samples were available, were included in the analysis. For changes in HbA1c and body weight a clinically relevant change of 5≥mmom/mol and 5%≥, respectively, was chosen. Participants were divided into groups according to their baseline HbA1c level: "Diabetes": HbA1c of ≥6.5% (≥48 mmol/mol), "Prediabetes": HbA1c of 5.7% to 6.4% (39-47.99 mmol/mol) or "Normal" HbA1c <5.7% (<39 mmol/mol). 180 patients met the stated inclusion criteria and these patients were divided into groups (median age (25th;75th quartile): Diabetes: n=47, age 54 (43;60), 51% women, Prediabetes: n=68, age 60 (50;66), 71% women and Normal: n=65, median age 61 (50;66), 85% women. Significant reductions were found in all three groups and specifically in the diabetes group HbA1c was reduced (mean [95%CI]) -5[-8;-2] mmol/mol from baseline to the end of the intervention. Furthermore, 35% of patients with prediabetes normalized their HbA1c (<39) and 30% patients with diabetes reduced their HbA1c <48. All groups had clinically relevant (≥5%) reductions in body weight (p<0.01). There was an association between body weight reduction and HbA1c reduction in the diabetes group (p<0.01). All groups reported improvements in physical health (p<0.01). In this retrospective cohort study, all patients achieved clinically relevant weight loss after participation in the lifestyle intervention and obese patients with diabetes achieved clinically relevant reductions in HbA1c after 6-months. More than 1/3 of patients with prediabetes normalized their HbA1c.

Behavioral Lifestyle Intervention Program Using Mobile Application Improves Diet Quality in Adults With Prediabetes (D’LITE Study): A Randomized Controlled Trial

BackgroundMobile health applications (mHealth apps) are increasingly being used in weight loss interventions. However, evidence on the effects of such interventions on diet quality and their correlation with weight loss is lacking. ObjectiveThe objective of this study was to examine whether changes in the diet quality of adults with prediabetes followed the use of an mHealth-enabled lifestyle intervention, compared with those who did not, and whether these changes correlated with weight loss. DesignA secondary analysis of a 6-month randomized controlled trial Diabetes Lifestyle Intervention using Technology Empowerment (D’LITE) was conducted, with participants recruited from October 2017 to September 2019. Participants/settingCommunity-dwelling adults (n = 148) in Singapore diagnosed with prediabetes and body mass index (BMI) ≥23 were included in this study. InterventionParticipants were randomized to receive either a 6-month mHealth-enabled lifestyle intervention program (diet and physical activity) or standard care dietary advice. Main outcome measuresDietary data were collected in the form of 2-day food records at baseline, 3, and 6 months. Changes in Alternate Healthy Eating Index-2010 (AHEI-2010) scores and food groups (servings/day), calculated from the dietary data, and correlation between changes in AHEI-2010 and weight loss at 3 and 6 months, were examined. Statistical AnalysesBetween-group comparisons of continuous variables and within-participants variation were performed using longitudinal mixed-effect models, intention-to-treat principles. The models included treatment groups, time (baseline, 3 months, and 6 months), and covariates (age, sex, and BMI), as well as the group × time interactions, as fixed variables and within-participant variation in outcome values as random variable. The random intercept for participants accounted for the dependence of repeated measures. A likelihood ratio test was also conducted to test random effect variance. Spearman correlation test was used to examine correlation between changes in AHEI-2010 scores and weight loss. ResultsThere was a significant improvement in overall diet quality as ascertained by the AHEI-2010, by 6.2 points (95% confidence interval [CI], 3.8–8.7; P < 0.001) in the intervention group as compared with the control. The participants in the intervention group had a significantly greater reduction in intake of sugar-sweetened beverages (SSB) by 0.5 servings/day (95% CI, −0.8, −0.2; P < 0.001) and sodium by 726 mg/day (95% CI, −983, −468; P < .001), compared with those receiving standard care. At 3 and 6 months, a significant decrease in SSB (0.8 servings/day; 0.7 servings/day, respectively) and sodium (297 mg/day; 296 mg/day, respectively) intakes were reported compared with baseline intakes. Small positive correlations (r = 0.2; P < 0.05) were observed between changes in AHEI-2010 scores from baseline and percentage weight loss at 3 and 6 months. ConclusionFor adults with prediabetes in Singapore, diet quality can be improved with an mHealth-enabled lifestyle intervention program. A small positive correlation exists between AHEI-2010 scores and weight loss.

Mechanisms of weight loss-induced remission in people with prediabetes: a post-hoc analysis of the randomised, controlled, multicentre Prediabetes Lifestyle Intervention Study (PLIS)

Remission of type 2 diabetes can occur as a result of weight loss and is characterised by liver fat and pancreas fat reduction and recovered insulin secretion. In this analysis, we aimed to investigate the mechanisms of weight loss- induced remission in people with prediabetes. In this prespecified post-hoc analysis, weight loss-induced resolution of prediabetes in the randomised, controlled, multicentre Prediabetes Lifestyle Intervention Study (PLIS) was assessed, and the results were validated against participants from the Diabetes Prevention Program (DPP) study. For PLIS, between March 1, 2012, and Aug 31, 2016, participants were recruited from eight clinical study centres (including seven university hospitals) in Germany and randomly assigned to receive either a control intervention, a standard lifestyle intervention (ie, DPP-based intervention), or an intensified lifestyle intervention for 12 months. For DPP, participants were recruited from 23 clinical study centres in the USA between July 31, 1996, and May 18, 1999, and randomly assigned to receive either a standard lifestyle intervention, metformin, or placebo. In both PLIS and DPP, only participants who were randomly assigned to receive lifestyle intervention or placebo and who lost at least 5% of their bodyweight were included in this analysis. Responders were defined as people who returned to normal fasting plasma glucose (FPG; <5·6 mmol/L), normal glucose tolerance (<7·8 mmol/L), and HbA1c less than 39 mmol/mol after 12 months of lifestyle intervention or placebo or control intervention. Non-responders were defined as people who had FPG, 2 h glucose, or HbA1c more than these thresholds. The main outcomes for this analysis were insulin sensitivity, insulin secretion, visceral adipose tissue (VAT), and intrahepatic lipid content (IHL) and were evaluated via linear mixed models. Of 1160 participants recruited to PLIS, 298 (25·7%) had weight loss of 5% or more of their bodyweight at baseline. 128 (43%) of 298 participants were responders and 170 (57%) were non-responders. Responders were younger than non-responders (mean age 55·6 years [SD 9·9] vs 60·4 years [8·6]; p<0·0001). The DPP validation cohort included 683 participants who lost at least 5% of their bodyweight at baseline. Of these, 132 (19%) were responders and 551 (81%) were non-responders. In PLIS, BMI reduction was similar between responders and non-responders (responders mean at baseline 32·4 kg/m2 [SD 5·6] to mean at 12 months 29·0 kg/m2 [4·9] vs non-responders 32·1 kg/m2 [5·9] to 29·2 kg/m2 [5·4]; p=0·86). However, whole-body insulin sensitivity increased more in responders than in non-responders (mean at baseline 291 mL/[min × m2], SD 60 to mean at 12 months 378 mL/[min × m2], 56 vs 278 mL/[min × m2], 62, to 323 mL/[min × m2], 66; p<0·0001), whereas insulin secretion did not differ within groups over time or between groups (responders mean at baseline 175 pmol/mmol [SD 64] to mean at 12 months 163·7 pmol/mmol [60·6] vs non-responders 158·0 pmol/mmol [55·6] to 154·1 pmol/mmol [56·2]; p=0·46). IHL decreased in both groups, without a difference between groups (responders mean at baseline 10·1% [SD 8·7] to mean at 12 months 3·5% [3·9] vs non-responders 10·3% [8·1] to 4·2% [4·2]; p=0·34); however, VAT decreased more in responders than in non-responders (mean at baseline 6·2 L [SD 2·9] to mean at 12 months 4·1 L [2·3] vs 5·7 L [2·3] to 4·5 L [2·2]; p=0·0003). Responders had a 73% lower risk of developing type 2 diabetes than non-responders in the 2 years after the intervention ended. By contrast to remission of type 2 diabetes, resolution of prediabetes was characterised by an improvement in insulin sensitivity and reduced VAT. Because return to normal glucose regulation (NGR) prevents development of type 2 diabetes, we propose the concept of remission of prediabetes in analogy to type 2 diabetes. We suggest that remission of prediabetes should be the primary therapeutic aim in individuals with prediabetes. German Federal Ministry for Education and Research via the German Center for Diabetes Research; the Ministry of Science, Research and the Arts Baden-Württemberg; the Helmholtz Association and Helmholtz Munich; the Cluster of Excellence Controlling Microbes to Fight Infections; and the German Research Foundation.

Therapeutic Lifestyle Intervention Targeting Enhanced Cardiometabolic Health and Function for Persons with Chronic Spinal Cord Injury in Caregiver/Care-Receiver Co-Treatment: A Study Protocol of a Multisite Randomized Controlled Trial.

Chronic spinal cord injury (SCI) significantly accelerates morbidity and mortality, partly due to the increased risk of cardiometabolic diseases (CMD), including neurogenic obesity, dyslipidemia, and impaired glucose metabolism. While exercise and dietary interventions have shown some transient benefits in reducing CMD risk, they often fail to improve clinically relevant disease markers and cardiovascular events. Moreover, SCI also places caregiving demands on their caregivers, who themselves experience health and functional decline. This underscores the need for more substantial interventions that incorporate appropriate physical activity, heart-healthy nutrition, and behavioral support tailored to the SCI population. This randomized clinical trial (RCT) protocol will (1) assess the health and functional effects, user acceptance, and satisfaction of a 6-month comprehensive therapeutic lifestyle intervention (TLI) adapted from the National Diabetes Prevention Program (DPP) for individuals with chronic SCI and (2) examine the impact of a complementary caregiver program on the health and function of SCI caregivers and evaluate user acceptance and satisfaction. Caregivers (linked with their partners) will be randomized to 'behavioral support' or 'control condition'. Dyadic couples comprise individuals with SCI (18-65 years, >1-year post-injury, ASIA Impairment Scale A-C, injury levels C5-L1) and non-disabled SCI caregivers (18-65 years). Both groups undergo lock-step circuit resistance training, a calorie-restricted Mediterranean-style diet, and 16 educational sessions focused on diet/exercise goals, self-monitoring, psychological and social challenges, cognitive behavioral therapy, and motivational interviewing. The outcome measures encompass the cardiometabolic risks, cardiorespiratory fitness, inflammatory stress, multidimensional function, pain, life quality, independence, self-efficacy, program acceptance, and life satisfaction for SCI participants. The caregiver outcomes include multidimensional function, pain, quality of life, independence, and perceived caregiver burden. This study evaluates the effects and durability of a structured, multi-modal intervention on health and function. The results and intervention material will be disseminated to professionals and consumers for broader implementation. ClinicalTrials.gov, ID: NCT02853149 Registered 2 August 2016.

Randomized Trial Evaluating a Self-Guided Lifestyle Intervention Delivered via Evidence-Based Materials versus a Waitlist Group on Changes in Body Weight, Diet Quality, Physical Activity, and Quality of Life among Breast Cancer Survivors.

Background: Lifestyle interventions for breast cancer survivors have proved effective at stimulating positive behavior change and promoting healthy weight loss, although integrating these programs into clinical practice is challenging. We evaluated the effect of a 6-month, unsupervised, self-guided, lifestyle intervention using printed materials and online videos vs. waitlist group on body weight for breast cancer survivors. Methods: The Lifestyle, Exercise and Nutrition (LEAN) Self-Guided trial randomized breast cancer survivors with a body mass index ≥25 kg/m2 to a 6-month lifestyle intervention (N = 102) or waitlist group (N = 103). Effects of the intervention on self-reported body weight, physical activity (PA), diet quality (via Health Eating Index-2010 (HEI-2010)), and quality of life were assessed using mixed model repeated measures analysis. Results: At 6 months, the intervention arm had significantly greater weight loss compared with the waitlist group (mean difference = -1.3 kg, 95% confidence interval [CI] = -2.5, -0.13). We observed suggestive improvements in PA (mean difference = 18.7 min/week, 95% CI = -24.2, 61.6), diet quality (mean difference in HEI = 3.2 points, 95% CI = -0.20, 6.5), and fatigue (mean difference in Functional Assessment of Chronic Illness Therapy-Fatigue scale = 1.4 points, 95% CI = -1.1, 3.9). Conclusions: The LEAN Self-Guided intervention led to favorable weight changes over 6 months. Low-resource-intensive programs have the potential to be delivered in diverse healthcare settings and may support breast cancer survivors in achieving a healthy body weight.

166-LB: Clinical Improvements and Extracellular Vesicle Size following Lifestyle Intervention in Latino Youth with Nonalcoholic Fatty Liver Disease

Latino youths with obesity are disproportionately impacted by nonalcoholic fatty liver disease (NAFLD). Lifestyle intervention can improve established biomarkers such as serum transaminases and hepatic fat fraction (HFF) in NAFLD patients. Circulating levels of extracellular vesicles (EVs) have been associated with NAFLD and may track with changes in liver fat. Here we assessed changes in EV concentration and size following a comprehensive lifestyle intervention in 18 Latino adolescents (12 males/6 females; average age 13.3 ±1.2y) with obesity and NAFLD, as defined by MRI-measured hepatic fat fraction (HFF) ≥5%. Participants completed a 6-month lifestyle intervention that targeted improvements in eating behaviors (e.g., decreased sugar and saturated fat intake, portion control, and increased fiber intake) and increases in physical activity. EVs were isolated from fasting plasma samples taken at baseline and following intervention using size exclusion chromatography and characterized by nanoparticle tracking analysis. Significant improvements (pre- vs post-intervention) were observed in percent body fat (44.7 ±4.8% vs 42.2 ±5.3%, p&amp;lt;0.0001), alanine transaminase (ALT; 24.8 ±7.4 U/L vs 23.2 ±5.6 U/L p=0.02), and HFF (12.5 ±5.5% vs 9.6 ±4.9%, p=0.008). We observed a significant reduction in mean EV size (128.4 ±16.5 vs 120.2 ±16.4, p=0.03) and a non-significant reduction in EV concentration (1.14E+09 ±4.1E+08 vs 1.09E+09 ±1.8E+08, p=0.61) following the intervention. Change in mean EV size was significantly and positively associated with changes in SAT (cm3), HDL (mg/dl), fat (kg) and BMI (all p &amp;lt; 0.05). These results suggest that improvements in NAFLD-related phenotypes following lifestyle intervention correspond with reductions in EV size in Latino adolescents with obesity and NAFLD. Disclosure I. Piras: None. X. Wu: None. P. Pirrotte: None. M. Olson: Advisory Panel; Rhythm Pharmaceuticals, Inc. S. Khan: None. S. Xanthakos: None. G. Q. Shaibi: None. J. Distefano: None. Funding National Institutes of Health (R01DK127015)

1107-P: Insulin Sensitivity Changes from Adolescence to Young Adulthood

Background: Latino youth are disproportionately impacted by type 2 diabetes (T2D) and youth onset T2D is more aggressive and resistant to conventional treatment. Early prevention efforts are warranted for high-risk pediatric populations, but little is known about the long-term effects of such interventions. The purpose of this study was to examine health trajectories following a diabetes prevention program for Latino adolescents with obesity who are now young adults. Methods: Participants (N=61) completed a 3-month lifestyle intervention as adolescents (Mage = 15.4) and were re-contacted ~5 years post-intervention (Mage = 20.7 years). Measures included BMI and the Matsuda Index to estimate insulin sensitivity. Latent profile analysis was used to examine heterogeneity in changes in insulin sensitivity over time. Results: Participants exhibited significant reductions in BMI post-intervention (from 34.8±4.7 to 34.1±4.7, p &amp;lt;.001); however, BMI increased at 5-year follow up (40.5±8.4, p &amp;lt;.001). Similarly, insulin sensitivity increased by 23.5% post-intervention (from 1.7±1.0 to 2.1±1.0, p &amp;lt;.001) but returned to baseline levels at 5-years (1.8±1.4). Latent profile analysis identified two distinct trajectories in insulin sensitivity. Profile 1 was characterized by lower baseline insulin sensitivity (1.4 [1.2, 1.7]) followed by a 36% increase post-intervention (1.9 [1.6, 2.2]) that remained above baseline at 5 years (1.7 [1.3, 2.1]). Profile 2 exhibited a 31% increase from baseline insulin sensitivity (2.9 [1.6, 4.2]) after the intervention (3.8 [2.8, 4.8]) that fell below baseline at 5 years (2.7 [0.6-4.8]) Female sex significantly differentiated the trajectories and was associated with profile 1. Discussion: Despite improvements in diabetes-related health immediately following the intervention, weight gain and decreased insulin sensitivity persisted into young adulthood. The unique profiles suggest that there may be specific factors such as sex that can differentiate health trajectories over time. Disclosure M.Braxton: None. J.Jager: None. S.Ayers: None. M.Olson: Advisory Panel; Rhythm Pharmaceuticals, Inc. G.Q.Shaibi: None. Funding National Institute on Minority Health and Health Disparities (U54MD002316)

The effect of weight loss following 18 months of lifestyle intervention on brain age assessed with resting-state functional connectivity.

Obesity negatively impacts multiple bodily systems, including the central nervous system. Retrospective studies that estimated chronological age from neuroimaging have found accelerated brain aging in obesity, but it is unclear how this estimation would be affected by weight loss following a lifestyle intervention. In a sub-study of 102 participants of the Dietary Intervention Randomized Controlled Trial Polyphenols Unprocessed Study (DIRECT-PLUS) trial, we tested the effect of weight loss following 18 months of lifestyle intervention on predicted brain age based on magnetic resonance imaging (MRI)-assessed resting-state functional connectivity (RSFC). We further examined how dynamics in multiple health factors, including anthropometric measurements, blood biomarkers, and fat deposition, can account for changes in brain age. To establish our method, we first demonstrated that our model could successfully predict chronological age from RSFC in three cohorts (n=291;358;102). We then found that among the DIRECT-PLUS participants, 1% of body weight loss resulted in an 8.9 months' attenuation of brain age. Attenuation of brain age was significantly associated with improved liver biomarkers, decreased liver fat, and visceral and deep subcutaneous adipose tissues after 18 months of intervention. Finally, we showed that lower consumption of processed food, sweets and beverages were associated with attenuated brain age. Successful weight loss following lifestyle intervention might have a beneficial effect on the trajectory of brain aging. The German Research Foundation (DFG), German Research Foundation - project number 209933838 - SFB 1052; B11, Israel Ministry of Health grant 87472511 (to I Shai); Israel Ministry of Science and Technology grant 3-13604 (to I Shai); and the California Walnuts Commission 09933838 SFB 105 (to I Shai).

363 Association between self-monitoring and ketogenic diet adherence in a technology-assisted lifestyle intervention

OBJECTIVES/GOALS: Self-monitoring (SM) improves adherence to low-fat low-calorie (LFLC) diet for weight management. Ketogenic diet (KD) is a promising alternative to LFLC, however, it is unclear whether SM improves KD adherence. We examined the association between SM and KD adherence during the first 12 weeks of a 6-month technology-assisted lifestyle intervention. METHODS/STUDY POPULATION: We included 30 (50.8 ± 12.4 years, 70% female) overweight/obese (body mass index: 37.1 ± 7.2 kg/m2) participants in the analysis. They received personalized KD goals with very low-carbohydrate (22–62 g/d), moderate protein (52 -87 g/d), and high-fat (115 - 219g/d) and calorie intake goals (1338–2554 kcal/d). Additionally, participants performed daily diet, exercise, and weight SM. Adherence to KD was measured by (1) self-monitored dietary intake, and (2) percent of days in ketosis state (blood ketone≥0.5 mmol/L) captured by a fingerstick blood ketone meter. SM frequency was defined as percent of days participant logged food intake, wore fitness tracker, and weighed body weight. Pearson correlation coefficients were computed to examine the correlation between SM in diet, exercise, and weight with KD adherence. RESULTS/ANTICIPATED RESULTS: Percentage of days participants SM for diet, exercise, and weight was 58.4 ± 32.2%, 66.4 ± 30.9%, and 59.0 ± 32.6%, respectively. Correlational analysis more frequent diet SM was positively correlated with more days in ketosis (r = 0.58, p = 0.003), higher fat intake (r = 0.68, p = 0.0001), and higher calorie intake (r = 0.67, p = 0.002) within the fat and calorie goals set; more frequent weight SM was positively correlated with more days in ketosis (r = 0.48, p = 0.02), higher fat intake (r = 0.45, p = 0.023), and higher calorie intake (r = 0.44, p = 0.027). DISCUSSION/SIGNIFICANCE: We found that diet and weight SM were positively associated with fat and calorie intake, as well as days in ketosis. Given the reported promising effect of KD on weight loss and the challenges of adhering to KD, our findings suggested that promoting SM on diet and weight might be a promising avenue for improving KD adherence leading to successful weight loss.

THE IMPACT OF BEHAVIORAL LIFESTYLE INTERVENTION ON INFLAMMATORY CYTOKINES IN OLDER ADULTS WITH TYPE 2 DIABETES

Abstract Chronic inflammation, a hallmark of type 2 diabetes (T2D) and adiposity, increases the risk for age-related co-morbidities, including physical frailty. This study aimed to examine the effects of a mobile technology-enhanced behavioral lifestyle educational intervention on frailty and associated clinical, inflammatory, and laboratory outcomes in overweight older adults with T2D. Twenty participants (≥65 years, BMI ≥25 kg/m2) with T2D were recruited to complete a single-arm 6-month lifestyle intervention modified from the Action for Health in Diabetes (Look AHEAD) study, enhanced with technology for self-monitoring of diet and physical activity. Clinical assessments were collected at baseline and end of the study and analyzed with paired t-tests. Inflammatory cytokines (interleukin [IL]2, IL4, IL6, IL8, IL10, granulocyte-macrophage colony-stimulating-factor [GM-CSF], interferon [IFNγ], tumor necrosis factor [TNFα]) were quantified using a commercially available multiplex kit (Millipore Sigma, Burlington, MA, USA). Clinical lab analysis was performed by Quest Diagnostics (Dallas, TX, USA). Eighteen participants completed the study (71.5±5.3 years; 56% female; 50% Hispanic). At baseline, 13 participants were pre-frail, 4 were frail based on Fried frailty criteria. Inflammatory cytokines and liver enzymes values were within normal limits. At follow-up, the following outcomes significantly improved: frailty score -44% (p=0.01), BMI -3% (P&amp;lt; 0.00), alanine transaminase -18% (p=0.03), aspartate aminotransferase -13% (p&amp;lt; 0.00), IL2 -33% (p=0.01), IL4 -31% (p=0.05), IFNγ -36% (p=0.03), GM-CSF -43% (p=0.03). No other significant differences were observed. The results suggest the efficacy of a technology-enhanced lifestyle intervention on frailty and associated clinical, inflammatory, and laboratory outcomes in overweight older adults with T2D.

Medically tailored meals for food insecurity and type 2 diabetes: Protocol for the Food as Medicine for Diabetes (FAME-D) trial

BackgroundFood insecurity is associated with worse glycemic management for individuals with type 2 diabetes mellitus (T2DM), but whether medically tailored meals (MTM), a food insecurity intervention, can improve glycemic management is unclear. ObjectiveTo describe the protocol for a trial assessing whether an MTM plus lifestyle intervention improves hemoglobin A1c (HbA1c) and participant-reported outcomes, relative to a food subsidy (money that can be spent on foods participants choose), for adults with both T2DM and food insecurity. MethodsThe Food as Medicine for Diabetes (FAME-D) randomized clinical trial (goal n = 200) is a pragmatic trial with an active comparator. Participants, who will have T2DM and report food insecurity, will be randomly assigned to a 6-month MTM plus telephone-delivered lifestyle change intervention, or a 6-month food subsidy ($40/month). The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along with weight, food insecurity, diabetes distress, and health-related quality of life. Qualitative analyses of semi-structured interviews will help understand why, how, and under what circumstances the intervention achieved its observed results. ConclusionResults from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are considering coverage for MTM interventions.ClinicalTrials.gov: NCT04828785

Acceptability, feasibility and preliminary impact evaluation of a pilot text-message study on improving the health of Aboriginal people with, or at risk of, chronic disease in Australia.

Aboriginal people experience higher rates of chronic disease than other Australians, largely due to modifiable risk factors. This study aimed to evaluate the acceptability, feasibility and preliminary impact of a pilot text-message program on improving the health of Aboriginal people with, or at risk of, chronic disease. A before and after study using a convenience sample of Aboriginal Australian adults determined the impact of a 6-month healthy lifestyle text-message intervention on lifestyle behavioural measures including nutrition, physical activity and smoking. Process evaluation of participants and program facilitators determined program acceptability and feasibility. Twenty Aboriginal people enrolled in the study, with high study completion and program acceptability. The two program facilitators reported the low-cost automated text-message program to be highly acceptable, feasible to deliver and led to environmental program changes. Preliminary impact data showed significant improvements in vegetable consumption at 3 and 6months, but not for other health outcome measures. The text-message program was highly acceptable and feasible to deliver, and has potential as an adjunct to usual care. Further research is required to determine program efficacy with a larger sample size. SO WHAT?: Text-messages to improve the health of Aboriginal people are highly acceptable, feasible to deliver and can complement existing community-led group programs. Further testing of this low-cost program is warranted to determine program efficacy.

A healthy lifestyle text message intervention for adolescents: protocol for the Health4Me randomized controlled trial

BackgroundAdolescence presents a window of opportunity to establish good nutrition and physical activity behaviours to carry throughout the life course. Adolescents are at risk of developing cardiovascular and other chronic diseases due to poor the complex interplay of physical and mental health lifestyle risk factors. Text messaging is adolescents main form of everyday communication and text message programs offer a potential solution for support and improvement of lifestyle health behaviours. The primary aim of this study is to determine effectiveness of the Health4Me text message program to improve adolescent’s physical activity or nutrition behaviours among adolescents over 6-months, compared to usual care.MethodsHealth4Me is a virtual, two-arm, single-blind randomised controlled trial, delivering a 6-month healthy lifestyle text message program with optional health counselling. Recruitment will be through digital advertising and primary care services. In total, 390 adolescents will be randomised 1:1 to intervention or control (usual care) groups. The intervention group will receive 4–5 text messages per week for 6-months. All text messages have been co-designed with adolescents. Messages promote a healthy lifestyle by providing practical information, health tips, motivation and support for behaviour change for physical activity, nutrition, mental health, body image, popular digital media and climate and planetary health. Virtual assessments will occur at baseline and 6-months assessing physical health (physical activity, nutrition, body mass index, sleep), mental health (quality of life, self-efficacy, psychological distress, anxiety, depression, eating disorder risk) and lifestyle outcomes (food insecurity and eHealth literacy).DiscussionThis study will determine the effectiveness of a 6-month healthy lifestyle text message intervention to improve physical activity and nutrition outcomes in adolescents.Trial registrationAustralia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000949785, Date registered: 05/07/2022.

Clinic Based, Patient Choice Driven Lifestyle Intervention Lowers HbA1c In Type 2 Diabetes

The hyperglycemia associated with type 2 diabetes (T2D) results in substantially increased morbidity and mortality risk. Though efficacious pharmacotherapies exist, glycemic control remains poor with 33-49% of patients not meeting targets for glycemic control as quantified by HbA1c. While traditional lifestyle interventions have been shown to improve health outcomes, adherence is low. PURPOSE: This study sought to determine the efficacy of a clinic-based, menu-driven intervention on measures of glycemia and cardiovascular health. METHODS: Patients with T2D (n = 20; 56.7 ± 12y; 33.7 ± 7.2 BMI) with an HbA1c of 7.5-10% not requiring injectable insulin were recruited from an outpatient, family medicine clinic in Phoenix, AZ and underwent a quasi-experimental 3-month lifestyle intervention. In addition to behavioral counseling, subjects were given a daily menu of exercise and nutritional options and had to choose one option from each category. Exercise options: Moderate intensity (MOD) 3 x 10-minute bouts, MOD 1 x 30-minute bout, 2 minutes every hour at a high or MOD, and 10 x 1-minute bouts of high intensity (RPE 17-19). The dietary choices included: apple cider vinegar, psyllium husk powder, unsalted tree nuts, avocados, or extra virgin olive oil. Behavioral health counseling utilized motivational interviewing, acceptance and commitment therapy, and problem-solving therapy to promote behavior change. The intervention was administered to patients by medical assistants in a family medicine clinic and overseen by exercise physiologists and physicians. Wilcoxon Signed Rank tests were used to analyze pre- and post-intervention differences. RESULTS: A reduction in HbA1c of 0.5% was observed after the intervention (8.6 ± 0.9 vs. 8.1 ± 1.2% respectively; p = 0.05). Additionally, there was a reduction in waist circumference (115.5 ± 12.6 vs. 112.5 ± 15.2 cm; p = 0.014), body weight (97.7 ± 21.9 vs. 95.6 ± 23.9 kg; p = 0.016), and BMI (33.7 ± 7.2 vs 32.8 ± 7.5 kg/m2; p = 0.028). CONCLUSIONS: Our pilot data suggest that a lifestyle intervention administered by medical assistants in a family medicine clinic demonstrates improvements in glycemic control, waist circumference, and BMI in T2D. These results remain to be verified in a randomized controlled trial setting. Funding: Dignity Health/ASU Strategic Initiatives Program

Changes in health behaviours in adults at-risk of chronic disease: primary outcomes from the My health for life program

BackgroundChronic disease is the leading cause of premature death globally, and many of these deaths are preventable by modifying some key behavioural and metabolic risk factors. This study examines changes in health behaviours among men and women at risk of diabetes or cardiovascular disease (CVD) who participated in a 6-month lifestyle intervention called the My health for life program.MethodsThe My health for life program is a Queensland Government-funded multi-component program designed to reduce chronic disease risk factors amongst at-risk adults in Queensland, Australia. The intervention comprises six sessions over a 6-month period, delivered by a trained facilitator or telephone health coach. The analysis presented in this paper stems from 9,372 participants who participated in the program between July 2017 and December 2019. Primary outcomes included fruit and vegetable intake, consumption of sugar-sweetened drinks and take-away, alcohol consumption, tobacco smoking, and physical activity. Variables were summed to form a single Healthy Lifestyle Index (HLI) ranging from 0 to 13, with higher scores denoting healthier behaviours. Longitudinal associations between lifestyle indices, program characteristics and socio-demographic characteristics were assessed using Gaussian Generalized Estimating Equations (GEE) models with an identity link and robust standard errors.ResultsImprovements in HLI scores were noted between baseline (Md = 8.8; IQR = 7.0, 10.0) and 26-weeks (Md = 10.0; IQR = 9.0, 11.0) which corresponded with increases in fruit and vegetable consumption and decreases in takeaway frequency (p < .001 for all) but not risky alcohol intake. Modelling showed higher average HLI among those aged 45 or older (β = 1.00, 95% CI = 0.90, 1.10, p < .001) with vocational educational qualifications (certificate/diploma: β = 0.32, 95% CI = 0.14, 0.50, p < .001; bachelor/post-graduate degree β = 0.79, 95% CI = 0.61, 0.98, p < .001) while being male, Aboriginal or Torres Strait Islander background, or not currently working conferred lower average HLI scores (p < .001 for all).ConclusionsWhile participants showed improvements in dietary indicators, changes in alcohol consumption and physical activity were less amenable to the program. Additional research is needed to help understand the multi-level barriers and facilitators of behaviour change in this context to further tailor the intervention for priority groups.

A 12-month weight loss intervention in adults with obstructive sleep apnoea: is timing important? A step wedge randomised trial

Background/ObjectivesContinuous positive airway pressure (CPAP) concomitant with weight loss is a recommended treatment approach for adults with moderate-severe obstructive sleep apnoea (OSA) and obesity. This requires multiple synchronous behaviour changes. The aim of this study was to examine the effectiveness of a 6-month lifestyle intervention and to determine whether the timing of starting a weight loss attempt affects weight change and trajectory after 12 months in adults newly diagnosed with moderate-severe OSA and treated at home with overnight CPAP.MethodsUsing a stepped-wedge design, participants were randomised to commence a six-month lifestyle intervention between one and six-months post-enrolment, with a 12-month overall follow-up. Adults (n = 60, 75% males, mean age 49.4 SD 10.74 years) newly diagnosed with moderate-severe OSA and above a healthy weight (mean BMI 34.1 SD 4.8) were recruited.ResultsAfter 12 months, exposure to the intervention (CPAP and lifestyle) resulted in a 3.7 (95% CI: 2.6 to 4.8, p < 0.001) kg loss of weight compared to the control condition (CPAP alone). Timing of the weight loss attempt made no difference to outcomes at 12 months. When exposed to CPAP only (control period) there was no change in body weight (Coef, [95% CI] 0.03, [−0.3 to 0.36], p = 0.86).ConclusionsThe lifestyle intervention resulted in a modest reduction in body weight, while timing of commencement did not impact the degree of weight loss at 12 months. These findings support the recommendation of adjunctive weight-loss interventions within six-months of starting CPAP.