Lifestyle Intervention Group Research Articles

Group Lifestyle Intervention With Mobile Health for Young Adults With Serious Mental Illness: A Randomized Controlled Trial.

Evidence-based lifestyle interventions tailored to young adults with serious mental illness are needed to reduce their cardiometabolic risk. This study evaluated the effectiveness of a group lifestyle intervention ("PeerFIT") enhanced with mobile health (mHealth) compared with one-on-one mHealth coaching (basic education supported by activity tracking [BEAT]) for young adults with serious mental illness who were overweight or obese. Participants were young adults ages 18-35 years with serious mental illness and a body mass index ≥25 kg/m2, who were randomly assigned to PeerFIT or BEAT. Research staff collected data at baseline and at 6 and 12 months. Main outcomes were clinically significant changes from baseline in weight (≥5% weight loss), cardiorespiratory fitness (CRF; increase of >50 m on the 6-minute walk test), and cardiovascular disease (CVD) risk reduction (clinically significant weight loss or CRF improvement). Participants were 150 young adults with a mean ± SD body mass index of 37.1±7.4. Intent-to-treat analyses revealed no significant between-group difference for weight-loss, CRF, or CVD outcomes at 6 and 12 months. Participants in both conditions achieved clinically significant CVD risk reduction, weight loss, and CRF from baseline to 6 and 12 months, and all these improvements were statistically significant (p<0.01). The PeerFIT group lifestyle intervention was not superior to one-on-one mHealth coaching in achieving clinically significant changes in weight, CRF, and CVD risk reduction. Although both interventions improved outcomes, low-intensity mHealth coaching may be a more scalable approach for addressing modifiable cardiometabolic risk factors among young adults with serious mental illness.

Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention

Research questionWhat is the effect of weight loss through different interventions (three-component lifestyle intervention with short message service [SMS+] versus three-component lifestyle intervention without SMS [SMS–] versus care as usual [CAU]) on polycystic ovary syndrome (PCOS) characteristics (ovulatory dysfunction, hyperandrogenism, polycystic ovarian morphology [PCOM]) and phenotype distribution? DesignAnalysis of secondary outcome measures of a randomized controlled trial. Women diagnosed with PCOS (n = 183), who wished to become pregnant, with a body mass index above 25 kg/m², were assigned to a 1-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention group, with or without SMS, or to CAU (advice to lose weight). ResultsThe prevalence of biochemical hyperandrogenism was 30.9% less in the SMS- group compared with CAU after 1 year (P = 0.027). Within-group analyses revealed significant improvements in ovulatory dysfunction (SMS+: –39.8%, P = 0.001; SMS–: –30.5%, P = 0.001; CAU: –32.1%, P < 0.001), biochemical hyperandrogenism (SMS–: –27.8%, P = 0.007) and PCOM (SMS–: –14.0%, P = 0.034). Weight loss had a significantly favourable effect on the chance of having ovulatory dysfunction (estimate 0.157 SE 0.030, P < 0.001) and hyperandrogenism (estimate 0.097 SE 0.027, P < 0.001). ConclusionsAll groups demonstrated improvements in PCOS characteristics, although these were more profound within the lifestyle intervention groups. Weight loss per se led to an amelioration of diagnostic characteristics and in the phenotype of PCOS. A three-component lifestyle intervention aimed at a 5–10% weight loss should be recommended for all women with PCOS before they become pregnant.

Microbiota engraftment after faecal microbiota transplantation in obese subjects with type 2 diabetes: a 24-week, double-blind, randomised controlled trial

ObjectiveThe impact of faecal microbiota transplantation (FMT) on microbiota engraftment in patients with metabolic syndrome is uncertain. We aimed to study whether combining FMT with lifestyle modification could enhance the...

Effects of a Protein-Rich, Low-Glycaemic Meal Replacement on Changes in Dietary Intake and Body Weight Following a Weight-Management Intervention-The ACOORH Trial.

Although meal replacement can lead to weight reduction, there is uncertainty whether this dietary approach implemented into a lifestyle programme can improve long-term dietary intake. In this subanalysis of the Almased Concept against Overweight and Obesity and Related Health Risk (ACOORH) study (n = 463), participants with metabolic risk factors were randomly assigned to either a meal replacement-based lifestyle intervention group (INT) or a lifestyle intervention control group (CON). This subanalysis relies only on data of participants (n = 119) who returned correctly completed dietary records at baseline, and after 12 and 52 weeks. Both groups were not matched for nutrient composition at baseline. These data were further stratified by sex and also associated with weight change. INT showed a higher increase in protein intake related to the daily energy intake after 12 weeks (+6.37% [4.69; 8.04] vs. +2.48% [0.73; 4.23], p < 0.001) of intervention compared to CON. Fat and carbohydrate intake related to the daily energy intake were more strongly reduced in the INT compared to CON (both p < 0.01). After sex stratification, particularly INT-women increased their total protein intake after 12 (INT: +12.7 g vs. CON: −5.1 g, p = 0.021) and 52 weeks (INT: +5.7 g vs. CON: −16.4 g, p = 0.002) compared to CON. Protein intake was negatively associated with weight change (r = −0.421; p < 0.001) after 12 weeks. The results indicate that a protein-rich dietary strategy with a meal replacement can improve long-term nutritional intake, and was associated with weight loss.

No sustained effects of an intervention to prevent excessive GWG on offspring fat and lean mass at 54 weeks: Yet a greater head circumference persists.

LIFT (Lifestyle Intervention for Two) trial found that intervening in women with overweight and obesity through promoting healthy diet and physical activity to control gestational weight gain (GWG) resulted in neonates with greater weight, lean mass and head circumference and similar fat mass at birth. Whether these neonate outcomes are sustained at 1-year was the focus of this investigation. Measures included body composition by PEA POD air displacement plethysmography (ADP) and Echo Infant quantitative magnetic resonance (QMR) and head circumference at birth (n=169), 14 (n=136) and 54 weeks (n=137). Differences in fat and lean mass between lifestyle intervention (LI) and Usual care (UC) groups were examined using ANCOVA adjusting for maternal age and BMI, GWG, offspring sex and age. Compared to UC, LI infants had similar weight (112 ± 131 g; P=.40), fat mass (14 ± 80 g; P=.86), lean mass (100 ± 63 g; P=.12) at 14 weeks and similar weight (168 ± 183 g; P=.36), fat mass (148 ± 124 g; P=.24), lean mass (117 ± 92 g; P=.21) at 54 weeks. Head circumference was greater in LI at 54 weeks (0.46 ± 2.1cm P=.03). Greater lean mass observed at birth in LI offspring was not sustained at 14 and 54 weeks, whereas the greater head circumference in LI offspring persisted at 54 weeks.

U.S. POINTER (USA)

AbstractBackgroundU.S. POINTER aims to test whether a multidomain lifestyle intervention focused on physical and cognitive activity, nutrition, and risk factor management reduces risk of cognitive decline in a heterogeneous population of older adults in the U.S. The study adapts the FINGER (Finnish Intervention Geriatric Study to Prevent Cognitive Impairment and Disability) interventions to fit American culture and works with community partners at 5 sites across the country to develop sustainable community‐based intervention programs.MethodsU.S. POINTER is a 2‐year RCT that is enrolling 2000 cognitively normal older adults (60‐79 years) who are at risk for decline due sedentary lifestyle, poor diet and other factors such as family history of memory impairment and suboptimum cardiovascular health. Recruitment utilizes electronic health records, as well as grassroots approaches to engage traditionally underrepresented groups. Participants are randomized to one of two lifestyle intervention groups – Self‐Guided or Structured Lifestyle Intervention – that differ in format, intensity and accountability. U.S. POINTER includes partnerships with local chapters of the Alzheimer's Association and lifestyle specialists to assist with intervention delivery. The primary outcome is 2‐year change in cognitive function measured with a composite score that permits harmonization with FINGER.ResultsRecruitment began in 2019 at the vanguard site in North Carolina. Study progress at all 5 participating sites will be presented. Progress toward harmonization with FINGER and other international study teams in the WW‐FINGERS network will also be discussed.ConclusionAs a member of the WW‐FINGERS network of trials, U.S. POINTER provides an unprecedented opportunity to leverage lessons learned in FINGER and expand this work to test the generalizability of the findings to a heterogeneous American cohort with different cultural needs and practices. The results, in combination with those from other WW‐FINGERS studies, have the potential to identify a strategy to slow cognitive decline on a global scale.

PDB21 The Lifetime Cost-Effectiveness of Lifestyle Intervention or Metformin for Prevention of Diabetes Mellitus Type 2 in Obese Adults with Prediabetes from the Mexican Healthcare Perspective

Lifestyle interventions and metformin have been found to be both clinically effective and cost-effective in preventing the onset of diabetes mellitus type 2 (DMT2) in different settings. However, evidence is lacking for Mexico. The objective of this study was to analyze the lifetime cost-utility of lifestyle intervention and metformin compared with placebo, as well as lifestyle intervention compared with metformin in obese adults with prediabetes from the Mexican healthcare perspective. A Markov cohort simulation was used to track disease progression, direct medical costs and quality-adjusted life years (QALYs) to ultimately calculate the cost per QALY. Clinical evidence from the U.S. Diabetes Prevention Program on the progression from prediabetes to DMT2 was combined with data from the U.K. Prospective Diabetes Study on progression to common diabetes-related complications. Resource use was valued based on country-specific tariffs. Health utilities were derived from Mexican and U.S. studies. Uni- and bivariate sensitivity analyses were performed to test the robustness of the model. Uncertainty around the results was characterized in a probabilistic sensitivity analysis. All incremental cost-effectiveness ratios resulted negative. Lifestyle intervention and metformin were associated with an incremental net monetary benefit (INMB) of 1,451.57 US$ and 2,439.33 US$, respectively, compared with placebo at the threshold of once the national gross domestic product per capita per QALY. Lifestyle intervention compared with metformin was cost-saving with an INMB of 987,76 US$. The results were robust to structural changes and modifications in the lifestyle intervention group. The outcomes revealed constantly low levels of uncertainty. The results indicate that lifestyle intervention is a highly cost-effective alternative to treat prediabetes in obese adults in Mexico. However, its clinical effectiveness in Mexicans needs to be examined more thoroughly and a multi-sectoral approach to combat obesity and diabetes should be considered to overcome barriers to the successful implementation.

Pointer‐ZZZ: Sleep ancillary to U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk of Alzheimer's disease

AbstractBackgroundNon‐pharmacological approaches that target modifiable risks through lifestyle interventions provide the most promising evidence to delay disease. In older adults, chronic sleep disturbances marked by sleep‐disordered breathing (SDB) and sleep fragmentation are associated with impaired hippocampal functioning, increased beta‐amyloid burden, and greater Alzheimer’s risk. These and other sleep abnormalities are associated with reduced vascular health. Although some evidence suggests that diet, exercise, and cardiovascular risk reduction can improve sleep and improved sleep benefits cognition in older adults, these effects have not been confirmed in a rigorous clinical trial.MethodsThe U.S. study to PrOtect brain health through lifestyle INTErvention to Reduce risk (U.S. POINTER), funded by the Alzheimer’s Association, was launched in the Fall of 2018. It is investigating whether lifestyle interventions ‐ Self‐Guided (SG) versus a Structured (STR) lifestyle intervention ‐ influence cognitive trajectories over 2 years in 2000 older cognitively normal adults (aged 60‐79 yrs) who are at increased risk for cognitive decline, Alzheimer’s disease and other dementias. The NIH‐funded POINTER‐zzz ancillary study adds in‐home objective sleep assessments for 700 participants to examine the effects of lifestyle modification and cardiovascular risk management on sleep disturbances that are linked to cognitive decline and Alzheimer’s disease and that may improve with U.S. POINTER interventions.ResultsPOINTER‐zzz methods and study design will be presented, which will permit over 2000 objective sleep assessments to be completed over 2 years. These assessments will provide extensive oximetry and actigraphy data for analysis by lifestyle intervention group assignment. Sleep data will be examined relative to intervention effects on cognition and other parent trial and ancillary study outcomes, including MRI and amyloid/tau PET brain imaging. POINTER‐zzz leverages resources provided by the parent trial and other funded ancillary studies, and by well‐established collaborations with sleep experts.ConclusionsPOINTER‐zzz provides an unparalleled opportunity to test the effects of a multi‐domain lifestyle intervention on sleep abnormalities that are linked to cognitive decline and Alzheimer’s in a well‐characterized, diverse cohort of at‐risk older adults. The study may identify an effective strategy for improving sleep that could have important consequences for reduced risk of Alzheimer’s disease and related dementias.

Feasibility of a Lifestyle Intervention Program for Prevention of Diabetes Among Women With Prior Gestational Diabetes Mellitus (LIVING Study) in South Asia: A Formative Research Study.

Aim: To refine and contextually adapt a postpartum lifestyle intervention for prevention of type 2 diabetes mellitus (T2DM) in women with prior gestational diabetes mellitus (GDM) in Bangladesh, India, and Sri Lanka.Materials and Methods: In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted with women with current diagnosis of GDM, and health care professionals involved in their management, to understand relevant local contextual factors for intervention optimization and implementation. This paper describes facilitators and barriers as well as feedback from participants on how to improve the proposed intervention. These factors were grouped and interpreted along the axes of the three main determinants of behavior–capability, opportunity, and motivation. IDIs and FGDs were digitally recorded, transcribed, and translated. Data-driven inductive thematic analysis was undertaken to identify and analyze patterns and themes.Results: Two interrelated themes emerged from the IDIs and FGDs: (i) The lifestyle intervention was acceptable and considered to have the potential to improve the existing model of care for women with GDM; and (ii) Certain barriers such as reduced priority of self-care, and adverse societal influences postpartum need to be addressed for the improvement of GDM care. Based on the feedback, the intervention was optimized by including messages for family members in the content of the intervention, providing options for both text and voice messages as reminders, and finalizing the format of the intervention session delivery.Conclusion: This study highlights the importance of contextual factors in influencing postpartum care and support for women diagnosed with GDM in three South Asian countries. It indicates that although provision of postpartum care is complex, a group lifestyle intervention program is highly acceptable to women with GDM, as well as to health care professionals, at urban hospitals.

Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability

Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers. To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending. This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending. Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial. Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility. This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03). This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending. ClinicalTrials.gov Identifier: NCT03952728.

Telomere Length Change in a Multidomain Lifestyle Intervention to Prevent Cognitive Decline: A Randomized Clinical Trial.

BackgroundShorter leukocyte telomere length (LTL) is associated with aging and dementia. Impact of lifestyle changes on LTL, and relation to cognition and genetic susceptibility for dementia, has not been investigated in randomized controlled trials (RCTs).MethodsFinnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability is a 2-year RCT enrolling 1260 participants at risk for dementia from the general population, aged 60–77 years, randomly assigned (1:1) to multidomain lifestyle intervention or control group. The primary outcome was cognitive change (Neuropsychological Test Battery z-score). Relative LTL was measured using quantitative real-time polymerase chain reaction (trial registration: NCT01041989).ResultsThis exploratory LTL substudy included 756 participants (377 intervention, 379 control) with baseline and 24-month LTL measurements. The mean annual LTL change (SD) was −0.016 (0.19) in the intervention group and −0.023 (0.17) in the control group. Between-group difference was nonsignificant (unstandardized β-coefficient 0.007, 95% CI −0.015 to 0.030). Interaction analyses indicated better LTL maintenance among apolipoprotein E (APOE)-ε4 carriers versus noncarriers: 0.054 (95% CI 0.007 to 0.102); younger versus older participants: −0.005 (95% CI −0.010 to −0.001); and those with more versus less healthy lifestyle changes: 0.047 (95% CI 0.005 to 0.089). Cognitive intervention benefits were more pronounced among participants with better LTL maintenance for executive functioning (0.227, 95% CI 0.057 to 0.396) and long-term memory (0.257, 95% CI 0.024 to 0.489), with a similar trend for Neuropsychological Test Battery total score (0.127, 95% CI −0.011 to 0.264).ConclusionsThis is the first large RCT showing that a multidomain lifestyle intervention facilitated LTL maintenance among subgroups of older people at risk for dementia, including APOE-ε4 carriers. LTL maintenance was associated with more pronounced cognitive intervention benefits.Clinical Trials Registration NumberNCT01041989

Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial.

As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone. In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters. From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks. A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.

Results of a Pilot Trial of a Lifestyle Intervention for Stroke Survivors: Healthy Eating and Lifestyle after Stroke

ObjectivesAlthough healthy lifestyle practices mitigate recurrent stroke risk and mortality, few stroke survivors adhere to them, particularly among socioeconomically disadvantaged communities. We developed and pilot tested a occupational therapy-based lifestyle management intervention, Healthy Eating And Lifestyle after Stroke (HEALS), to improve stroke survivors’ self-management skills relating to diet and physical activity and evaluated it in a diverse safety-net population. Materials and MethodsOne hundred English- or Spanish-speaking participants with stroke or transient ischemic attack were randomized to a 6-week occupational therapist-led group lifestyle intervention vs. usual care. Each of the six 2-h group sessions included didactic presentations on diet and physical activity, peer exchange, personal exploration with goal setting, and direct experience through participation in a relevant activity. Primary outcomes at 6 months were change in body mass index, fruit/vegetable intake, and physical activity. Secondary outcomes included change in waist circumference, smoking, blood pressure, high-density lipoprotein, low-density lipoprotein, triglyceride, total cholesterol, glycosylated hemoglobin levels, quality of care, and perceptions of care. Effect sizes were determined in preparation for a larger randomized controlled trial powered to detect a difference in primary outcomes. A nested formative evaluation assessed facilitators and barriers to implementation, acceptance, and intervention adherence. ResultsThere were no significant changes in primary or secondary outcomes at 6 months. Effect sizes for all outcomes were small (< 0.2). Focus group participants recommended extending the intervention program duration with more sessions, additional information on stroke and vascular risk factors, an interdisciplinary approach, additional family involvement, and incentives. Providers recommended longer program duration, more training, fidelity checks to ensure standardized program delivery, and additional incentives for participants. ConclusionsThe HEALS intervention was feasible in a safety-net setting, but effect sizes were small. A longer-duration intervention, with intervener fidelity checks may be warranted. Trial RegistrationNCT01550822.

Report from an effort to prevent type 2 diabetes development in primary care

BackgroundIn a clinical trial 2009–2012, individuals with prediabetes were randomised to a lifestyle intervention (LI) focused on physical activity or care as usual (CAU), with the aim of reducing development of type 2 diabetes (T2DM). At study termination after three years, there was a significantly less of an increase in insulin resistance in LI compared with the CAU group. The aim of this extended follow-up was to investigate whether positive results concerning metabolic variables remained five years after study termination. MethodAll participants from the original study were contacted for a new follow-up with an oral glucose tolerance test, anthropometric measurements, blood pressure and blood samples. Questionnaires about lifestyle were completed. ResultsA total of 69 of the original 123 participants were examined, and personal data for another five participants were collected from the medical charts (n = 74). The LI group showed a decrease in diastolic blood pressure (−4 mmHg, CI 95% 0.8–6.8, p = 0.014) and body weight (−3 kg, CI 95% 1.2–4.9, p = 0.002) since base-line. Weight loss in the LI group was significantly greater compared with weight loss in the CAU group (−3 kg, CI 0.1–5.9, p = 0.044). Insulin resistance markers and incident T2DM were similar among the groups. ConclusionAlthough without modifying the incidence of diabetes or the level of insulin resistance, a physical activity intervention may be used to induce sustainable weight change in subjects with prediabetes at the primary care level.

Associations of Lifestyle Intervention Effect with Blood Pressure and Physical Activity among Community-Dwelling Older Americans with Hypertension in Southern California.

A healthy lifestyle and regular physical activity are highly recommended for older adults. However, there has been limited research into testing lifestyle intervention effects on physical activity in older adults with hypertension. The purpose of this study was to assess the association of lifestyle intervention effects with physical activity and blood pressure in older adults with hypertension, accounting for social support and perceived stress as control variables. This study performed a secondary analysis of a two-arm randomized controlled trial. A total of 196 participants were randomly assigned to a six-month lifestyle intervention group or a control group. Hierarchical multiple regression analyses demonstrated that lifestyle intervention effects were not significantly associated with improvements in physical activity and blood pressure, but the final regression models were statistically significant (all p < 0.001). The result revealed that only physical activity frequency at baseline was significantly related to improvement in physical activity. Systolic blood pressure (SBP) at baseline and monthly income were significantly associated with change in SBP, while age and diastolic blood pressure (DBP) at baseline were significantly related to change in DBP. The findings provide empirical evidence for developing and optimizing lifestyle interventions for future research and clinical practice in this population.

Effects of a Lifestyle-Modification Program on Blood-Glucose Regulation and Health Promotion in Diabetic Patients: A Randomized Controlled Trial.

BackgroundWe aimed to investigate the efficacy of the lifestyle intervention (LSI) program in controlling blood glucose regulation and health promotion in type 2 diabetic (T2D) patients.MethodsThirty adults with a diagnosed with diabetes were randomly assigned to LSI and control groups. The LSI group maintained their daily routines after participating twice in the LSI program, while control group maintained 4 weeks of daily life without participating in an intervention.ResultsHbA1c levels in the LSI group decreased significantly after participation (p = 0.025) compared with levels before the study, but there was no significant difference between the groups. The weight and body mass index (BMI) of the LSI group tended to decrease significantly compared with the control group (p = 0.054 and p = 0.055, respectively), and the waist circumference (WC) of the LSI group decreased significantly compared with that of the control group (p = 0.048). In the effects of the LSI program according to the polymorphism of GCKR genes, changes in glycated albumin (GA) (%), HbA1c, WC, BMI, and weight showed a significant decrease in the non-risk (TT genotype) GCKR group compared with the risk group (CC and TC genotype).ConclusionApplication of the four-week LSI program to diabetics revealed positive effects on blood-glucose control and improvement in obesity indicators. In particular, the risk group with variations in the GCKR gene was associated with more genetic effects on indicators such as blood glucose and obesity than was the non-risk group.

Prediabetes Conversion to Normoglycemia Is Superior Adding a Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention—A 12-Month Subanalysis of the ACOORH Trial

Lifestyle interventions have been shown to reverse hyperglycemia to normoglycemia. However, these effects are not long-lasting and are accompanied with high dropout rates. As formula diets have been shown to be simple in usage and effective in improving glycemic control, we hypothesised that adding a low-carbohydrate and energy deficit formula diet to a low-intensity lifestyle intervention is superior in reversing prediabetes compared with lifestyle intervention alone. In this predefined subanalysis of an international, multicenter randomised controlled trial (Almased Concept against Overweight and Obesity and Related Health Risk (ACOORH) study (ID DRKS00006811)), 141 persons with prediabetes were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 45) or a lifestyle intervention group accompanied with a formula diet (INT, n = 96). Both groups were equipped with telemonitoring devices. INT received a low-carbohydrate formula diet substituting three meals/day (~1200 kcal/day) within the first week, two meals/day during week 2–4, and one meal/day during week 5–26 (1300–1500 kcal/day). Follow-up was performed after 52 weeks and 105 participants (75%, INT: n = 74; CON: n = 31) finished the 26-week intervention phase. Follow-up data after 52 weeks were available from 93 participants (66%, INT: n = 65; CON: n = 28). Compared with CON, significantly more INT participants converted to normoglycemia after 52 weeks (50% vs. 31%; p < 0.05). The risk reduction led to a number-needed-to-treat of 5.3 for INT. Lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than lifestyle intervention alone and is effective for type 2 diabetes prevention.

104-OR: Lifestyle Interventions in Persons with IGT Prolong the Time Free of Major Diabetes-Related Complications: 30-Year Results of the Da Qing Diabetes Prevention Outcome Study (DQDPOS)

Lifestyle interventions in persons with impaired glucose tolerance (IGT) delay the onset of diabetes, but freedom from complications is a major goal of diabetes prevention and management. The extent that lifestyle intervention can delay the onset of the common but serious complications of diabetes is ill-defined. We assessed freedom from any serious diabetes-related complication in the 30-year follow-up data from the Da Qing Diabetes Prevention study in which 576 adults with IGT, randomized to control or lifestyle intervention groups for six-years, were followed from the time of randomization to determine the onset of diabetes and occurrence of any serious diabetes-related complication defined as CVD events or death, severe retinopathy, nephropathy, neuropathy, or death due to acute diabetes complications or infection. We estimated differences between the intervention and control groups in the incidence and time free of serious complications. Lifestyle interventions significantly increased the time free of major serious diabetes-related complications (Table). The study provides yet further evidence supporting the value of implementing lifestyle interventions in persons with IGT. Disclosure Q. Gong: None. P. Zhang: None. J. Wang: None. Y. Chen: None. Y. An: None. X. Feng: None. Y.J. Cheng: None. J. Ma: None. P.H. Bennett: Advisory Panel; Self; World Health Organization. Stock/Shareholder; Self; Eli Lilly and Company, Pfizer Inc., Unilever, UnitedHealth Group. Other Relationship; Self; American Diabetes Association, European Association for the Study of Diabetes, European Diabetic Nephropathy Study Group, International Diabetes Federation, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health. G. Li: None.

2026-P: Efficacy of Internet-Based Intensive Weight Management or Exenatide Treatment on Weight Loss and Metabolism in Overweight/Obese PCOS

To evaluate efficacy of internet-based intensive weight management or exenatide treatment on weight loss and metabolism in overweight/obese patients with polycystic ovary syndrome(PCOS). The study recruited 50 overweight/obese patients with PCOS into intensive lifestyle intervention group(ILI) for internet-based intensive weight management, which characterized with strict-energy and low-carbohydrate diets(1100-1400 kcal of total energy and less than 50g of carbohydrates per day), nutritional meal-replacement diets for lunch and dinner, online reporting followed by nutrionists, exercises, behavioral intervention and medication(metformin, 500mg Tid), for 3 months. 50 BMI matched subjects assigned to 3 months of exenatide injection (10μg bid)in our previous study were recruited as control group (EXE group). Oral glucose tolerance test were performed to assess glucose tolerance and insulin sensitivity. Anthropometric, glycolipid metabolic markers, sex hormone level and inflammatory state were measured and compared between two intervention. After 3 months of intervention, decreases of weight(ILI group 10.02 ± 3.06 kg vs. EXE group 6.15 ± 2.28 kg), BMI (ILI group 3.98±1.26 kg/m2 vs. EXE group 2.54±1.05 kg/m2), HOMA-IR(2.60 ± 2.37 vs. 1.06 ± 2.04), WC, FBG, FINS, TG and UA in ILI group were more statistically significant than EXE group. There were no significant differences in decreases of 2hPBG, 2hINS, testosterone and hs-CRP between two groups(P&amp;gt; 0.05). There were no statistically differences in improvements of total cholesterol, LDL-C, ALT, and AST in both groups (P&amp;gt; 0.05). It is suggested that internet-based intensive weight management in overweight/obese PCOS can significantly reduce weight, improve central obesity and insulin resistance. These effects were significantly better than exenatide treatment. However there were no significant differences in improvements of testosterone level and inflammatory state. Disclosure S. Zheng: None. Y. Zhang: None. R. Li: None. J. Xue: None. H. Shen: None.

Effect of a Mediterranean Diet Intervention with and Without Weight Loss on the Gut Microbiota in Obese, Older Adults

Abstract Objectives Evidence suggests that the gut microbiome has profound implications on human health and is modifiable by diet and weight loss. The objective of this study was to determine the impact of an 8-month Mediterranean diet (Med Diet) intervention with and without weight loss, compared to a control group, on the diversity and abundance of gut bacteria in obese, older adults. We hypothesized that adoption of an energy-restricted Med Diet to promote weight loss would impact gut microbial structure and composition the most. Methods Subjects are a subset from a larger trial that were randomized (2:2:1, respectively) to one of the following 8-month interventions: (1) Med Diet group lifestyle intervention (n = 10); (2) Med Diet plus energy restriction group lifestyle intervention (n = 10); or (3) Control (n = 5). Anthropometrics, body composition, circulating metabolic and immune markers, body composition, lifestyle behaviors, and stool were collected at pre- and post-intervention. Sequencing of the microbial 16S rRNA V4 region was performed. SAS, DADA2 and R were used to examine Med Diet adherence, weight loss, and fecal microbiota structural and compositional changes post-intervention. Results Mean BMI at baseline was 35.8 kg/m2 (SD = 4.0) and mean age was 64.8 years (SD = 6.3). The subjects were primarily female (88%) and self-described as African American (96%). At post-intervention, the mean increase in Med Diet adherence for groups (1), (2), and (3) was 3.1, 3.8, and -0.8 points, respectively, and mean % weight loss was -2.8%, -7.2%, and 0.7%, respectively. Metagenomic analysis revealed that species richness, diversity and the relative abundance of the genera Lachnoclostridium, Veillonella, and Bifidobacterium and Blautia caecimuris increased significantly post-intervention among only the energy restricted Med Diet group. Conclusions Our study shows that an energy-restricted Med Diet that promotes weight loss in older, obese adults increases gut microbial species richness and diversity, which may have positive implications for human health. Funding Sources RO1 from National Institutes of Health- National Heart, Lung, and Blood Institute.