Trial Of Lifestyle Intervention Research Articles

A pilot randomised controlled trial of a multidomain lifestyle intervention for outpatients with chronic or severe mental illness.

A pilot randomised controlled trial of a multidomain lifestyle intervention for outpatients with chronic or severe mental illness.

Abstract B052: Exploring supplement utilization patterns among African American prostate and breast cancer survivors

Abstract Introduction: The American Cancer Society (ACS) defines dietary supplements as “vitamins and minerals, herbs and other botanicals, amino acids, enzymes, and more.” ACS advises against supplement use for cancer prevention, with no suggestions for survivors. Regardless, 64-81% of cancer survivors and 14-32% of recently diagnosed cancer patients in the U.S. will begin taking supplements to improve health outcomes. Despite this prevalence, few studies have examined supplement use in African American cancer survivors, and studies that have been done include small samples. This project examines supplement use across two genders and two cancer types within a population group historically underrepresented in research. Given the dearth of research to date, this project adds novel findings to the literature and informs future research.Objectives: This study describes supplement use in African American breast and prostate cancer survivors engaged in lifestyle intervention trials, identifies potential correlates of supplement use; and compares supplement use between the two populations. Methods: Men Moving Forward (MMF) is an ongoing lifestyle intervention study for African American prostate cancer survivors. Moving Forward (MF) is a completed lifestyle intervention study that included African American breast cancer survivors. Both studies examine the efficacy of a community-based intervention that promotes adherence to the American Cancer Society Nutrition and Physical Activity Guidelines. At baseline, study participants completed interviews that included a measure of supplement use including type, dose, frequency, and reason for use. Supplements were then categorized by type (e.g., Vitamin D, Vitamin B12) and descriptive analyses were conducted to examine most common types of supplements used, potential correlates of use, and to compare the two cancer survivor groups. Results: 114 men currently enrolled in the MMF study, and 223 women enrolled in MF completed the supplement use measure. Average ages of participants are 66.2 years (SD=7.5) for MMF and 57.5 years (SD=10.1) for MF. Supplement use was common, with 64.0% of MMF participants and 65.9% of MF participants using at least one supplement at baseline. Mean number of supplements was 1.62 (SD=1.9) for MMF and 1.76 (SD=2.0) for MF. The most used supplements were the same across survivor groups: Vitamin D (37.7% MMF, 38.1% MF), Multivitamins (27.2% MMF, 32.7% MF) and Omega-3 Fatty Acids (8.8% MMF, 19.3% MF). Age, education, and income will be explored as predictors of usage. Conclusions: Supplement use was prevalent among both survivor groups, consistent with national data for adult cancer survivors who report supplement use. However, our sample had higher usage rates compared to Non-Hispanic Black US adults without cancer (39.3% of men, 56.2% of women) from the 2023 National Health Statistics Report. Understanding supplement use in cancer survivors can identify potential risks and benefits of use, enhance patient-provider communication, and improve the quality-of-care patients receive. Citation Format: Carlene Kranjac, Estefania Alonso, Margaret Tovar, Sandra Contreras, Iwalola Awoyinka, Patricia Sheean, Melinda Stolley. Exploring supplement utilization patterns among African American prostate and breast cancer survivors [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B052.

Breastfeeding behaviours in women with obesity; associations with weight retention and the serum metabolome: a secondary analysis of UPBEAT.

Maternal obesity is associated with a decreased intention and initiation of breastfeeding as well as a shortened duration of breastfeeding. This analysis was undertaken to identify breastfeeding behaviours, and relationships with maternal anthropometry and the serum metabolome at 6-months postpartum in an ethnically diverse cohort of women with obesity. A cohort analysis of 715 women from the UK Pregnancies Better Eating and Activity Trial (UPBEAT); a multi-centre randomised controlled trial of an antenatal lifestyle intervention in women with obesity. Maternal data were collected in early pregnancy and included body mass index (BMI), socio-demographic characteristics and anthropometry. At 6-months postpartum, breastfeeding behaviours, anthropometry and 158 maternal metabolic measures from blood samples were recorded. Kaplan-Meier curves of breastfeeding duration were constructed and were stratified by obesity class (I: BMI 30.0-34.9 kg/m2, II: 35.0-39.9 kg/m2, III: ≥40.0 kg/m2). Relationships between breastfeeding behaviours, socio-demographic characteristics, the metabolome, and anthropometry were determined using regression analyses. Eighty-two percent (591/715) of the cohort-initiated breastfeeding and at the 6-month follow-up 40% (283/715) were breastfeeding exclusively or partially. Duration of exclusive breastfeeding decreased with increasing BMI: Compared to BMI class I (mean 90.4 ± 64 days) the difference in mean for classes II and III were -15.8 days (95% confidence interval: -28.5, -3.1, p < 0.05) and -16.7 (95% CI: -32.0 to -1.35, p < 0.05), respectively. Compared to no breastfeeding, any breastfeeding at 6-months postpartum was associated with improvements in metabolites towards a healthier profile, reduced weight retention by -1.81 kg (95% CI -0.75, -2.88, p < 0.05 ) and reduced anthropometric measures, including mid-upper arm and hip circumferences. The breastfeeding related changes in anthropometry were not evident in women of Black ethnicity. Greater emphasis on enabling breastfeeding for women with obesity could improve duration, women's weight management and metabolic health. The lack of breastfeeding related anthropometric effects in Black women requires further investigation. ISRCTN reference 89971375.

Optimizing the Implementation of a Lifestyle Dementia Prevention Intervention for Older Patients in an Academic Healthcare System.

Interventions that promote healthy lifestyles are critical for the prevention of Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD). However, knowledge of the best practices for implementing AD/ADRD prevention in healthcare settings remains limited. We aimed to qualitatively identify barriers and facilitators to implementing a clinical trial of a novel lifestyle intervention (My Healthy Brain) in our medical center for older patients with subjective cognitive decline who are at-risk for AD/ADRD. We conducted focus groups with 26 healthcare professionals (e.g., physicians, psychology, nursing) from 5 clinics that treat older patients (e.g., memory care, psychiatry). Our qualitative analysis integrated two implementation frameworks to systematically capture barriers and facilitators to AD/ADRD prevention (Consolidated Framework for Implementation Science Research) that impact implementation outcomes of acceptability, appropriateness, and feasibility (Proctor's framework). We found widespread support for an RCT of My Healthy Brain and AD/ADRD prevention. Participants identified barriers related to patients (stigma, technological skills), providers (dismissiveness of "worried well," doubting capacity for behavior change), clinics (limited time and resources), and the larger healthcare system (underemphasis on prevention). Implementation strategies guided by Expert Recommendations for Implementing Change (ERIC) included: developing tailored materials, training staff, obtaining buy-in from leadership, addressing stigmatized language and practices, identifying "champions," and integrating with workflows and resources. The results will inform our recruitment, enrollment, and retention procedures to implement the first randomized clinical trial of My Healthy Brain. Our study provides a blueprint for addressing multi-level barriers to the implementation of AD/ADRD prevention for older patients in medical settings.

Non-diabetes status after diagnosis of impaired glucose tolerance and risk of long-term death and vascular complications: A post hoc analysis of the Da Qing Diabetes Prevention Outcome Study.

The association between years of non-diabetes status after diagnosis of impaired glucose tolerance (IGT) and the risk of long-term death and cardiovascular outcomes needed to be clarified. In this post hoc analysis, we included 540 individuals with IGT who participated in the original Da Qing Diabetes Prevention Study (DQDPS). In the DQDPS, all participants were diagnosed with IGT by a 75 g oral glucose tolerance test and randomized to intervention or control groups with a 6-year lifestyle intervention trial. After the completion of the trial, death, cardiovascular events, and microvascular complications were monitored over a 30-year follow-up. In this post hoc analysis, the Cox analysis assessed the extended risk of these outcomes in individuals who either remained non-diabetes status or progressed to diabetes at the end of 2, 4, and 6 years after diagnosis of IGT. In all participants, the difference in the cumulative incidence rate of the outcomes between the diabetes and non-diabetes group gradually increased over 30 years. Compared with the diabetes group, a significantly lower risk of all-cause death (hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.57 to 0.97, p = 0.026), cardiovascular events (HR: 0.63; 95% CI: 0.49 to 0.82, p < 0.001), and microvascular complications (HR: 0.62; 95% CI: 0.45 to 0.86, p = 0.004) first emerged in individuals who remained non-diabetes at the 4 years visit, whereas the significant risk reduction in cardiovascular death was first observed at the end of 6 years (HR: 0.56; 95% CI: 0.39 to 0.81, p = 0.002) after adjustment for age, sex, smoking status, BMI, systolic blood pressure, blood glucose, total cholesterol, intervention, and medications (including insulin plus oral hypoglycaemics, antihypertensives, and lipid-lowering agents). The results in the original intervention group alone were similar to the whole group. The main limitations of our study are the limited number of participants and the sole ethnicity of the Chinese population. In this study, we observed that maintaining several years of non-diabetes status after IGT diagnosis was associated with a significant reduction in long-term risk of death and vascular complications, and for most of these outcomes, maintaining at least 4 years of non-diabetes status may be needed to achieve a significant risk reduction.

Maternal depressive symptom trajectories and associations with child feeding

BackgroundResponsive feeding, when caregivers attend to children’s signals of hunger and satiation and respond in an emotionally supportive and developmentally appropriate way, is associated with the development of healthy eating behaviors, improved diet quality, and healthy weight status for children. However, gaps in the literature remain on how factors, such as maternal depressive symptoms and child temperament, influence feeding interactions.MethodsThis longitudinal secondary data analysis explored the association between maternal depressive symptom trajectory and child temperament with maternal feeding practices in women with obesity who participated in a prenatal lifestyle intervention trial. Mothers self-reported depressive symptoms at baseline, 35 weeks gestation, and 6, 12, and 18 months postpartum. At 18- and 24-months postpartum, mothers completed self-reported assessments of feeding practices and child temperament and completed in-home video-recorded meals with their child, coded using the Responsiveness to Child Feeding Cues Scale. We used group-based trajectory modeling to identify distinct trajectories of depressive symptoms and generalized regressions to assess the association between symptom trajectory group and feeding. We also explored interactions between depressive symptoms and child temperament.ResultsThree distinct trajectories of depressive symptoms were identified: No-Minimal and Decreasing, Mild-Moderate and Stable, and Moderate-Severe and Stable. At 18-months, when compared to the No-Minimal and Decreasing group, membership in the Moderate-Severe and Stable group was associated with higher observed responsiveness to child satiation cues (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$B$$\\end{document} =2.3, 95%CI = 0.2, 4.4) and lower self-reported pressure to eat (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$B$$\\end{document}=-0.4, 95%CI= -0.7, 0.0). When compared to the No-Minimal and Decreasing group, membership in the Mild-Moderate and Stable group was associated with higher self-reported restriction (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$B$$\\end{document} =0.4, 95%CI = 0.0,0.7). The associations between trajectory group membership and feeding practices did not reach statistical significance at 24 months. Associations between depressive symptoms and restriction were moderated by child effortful control at 18 months \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$(B=0.2, 95\\% CI (0.0, 04)$$\\end{document}) and surgency at 24 months \\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$B=-0.3, 95\\% CI (-0.6, 0.0)$$\\end{document}).ConclusionA Moderate-Severe and Stable depressive symptom trajectory was associated with more responsive feeding practices and a Mild-Moderate and Stable trajectory was associated with higher restrictive feeding. Preliminary evidence suggests that depressive symptoms impact mothers’ ability to match their use of restriction to the temperamental needs of their child.

Effects of genetic risk on incident type 2 diabetes and glycemia: the T2D-GENE lifestyle intervention trial.

Lifestyle intervention prevents or delays type 2 diabetes (T2D) in subjects at a high risk of T2D. However, it is not known whether genetic variants modify the effect on incident T2D during lifestyle intervention. To investigate whether a low or high genetic risk has effects on incident T2D in a group-based lifestyle intervention study. The T2D-GENE trial involved 973 men from the Metabolic Syndrome in Men (METSIM) cohort, aged 50-75 years, body mass index ≥25 kg/m2, fasting plasma glucose 5.6-6.9 mmol/l, and HbA1c <48 mmol/mol and either a low or high genetic risk score for T2D. There were two intervention groups, a low (n=315) and high genetic risk for T2D (n=313). They were provided with a 3-year group-based intervention with access to a web portal focused on healthy diet and physical activity. There were also corresponding population-based control groups at low (n=196), and high genetic risk for T2D (n=149) who had two laboratory visits (0 and 3 years) and general health advice as a part of their METSIM cohort protocol. The primary outcome was incident T2D, and a secondary outcome glycemia. The intervention significantly lowered the risk of T2D among the participants with a high genetic risk for T2D (HR 0.30, 95% CI 0.16-0.56, p<0.001) whereas in the low genetic risk group the effect was not significant (HR 0.69, 95% CI 0.36-1.32, p=0.262). The intervention effect was not significantly different between the high and low genetic risk groups (p=0.135). The intervention significantly ameliorated the worsening of glycemia and decreased weight both in the low and high genetic risk groups. Our results showed that individuals with a high genetic risk for T2D benefited from a low-cost group-based intervention focusing on healthy diet and physical activity. Therefore, all individuals at risk of T2D should be encouraged to make lifestyle changes regardless of genetic risk.

A multidomain lifestyle intervention to maintain optimal cognitive functioning in Dutch older adults—study design and baseline characteristics of the FINGER-NL randomized controlled trial

BackgroundEvidence on the effectiveness of multidomain lifestyle interventions to prevent cognitive decline in older people without dementia is mixed. Embedded in the World-Wide FINGERS initiative, FINGER-NL aims to investigate the effectiveness of a 2-year multidomain lifestyle intervention on cognitive functioning in older Dutch at risk individuals.MethodsMulti-center, randomized, controlled, multidomain lifestyle intervention trial with a duration of 24 months. 1210 adults between 60–79 years old with presence of ≥ 2 modifiable risk factors and ≥ 1 non-modifiable risk factor for cognitive decline were recruited between January 2022 and May 2023 via the Dutch Brain Research Registry and across five study sites in the Netherlands. Participants were randomized to either a high-intensity or a low-intensity intervention group. The multidomain intervention comprises a combination of 7 lifestyle components (physical activity, cognitive training, cardiovascular risk factor management, nutritional counseling, sleep counseling, stress management, and social activities) and 1 nutritional product (Souvenaid®) that could help maintain cognitive functioning. The high-intensity intervention group receives a personalized, supervised and hybrid intervention consisting of group meetings (on-site and online) and individual sessions guided by a trained lifestyle coach, and access to a digital intervention platform that provides custom-made training materials and selected lifestyle apps. The low-intensity intervention group receives bi-monthly online lifestyle-related health advice via the digital intervention platform. Primary outcome is 2-year change on a cognitive composite score covering processing speed, executive function, and memory.ResultsWithin 17 months, participant recruitment has been successfully completed (N = 1210; mean age: 67.7 years (SD: 4.6); 64% female). Modifiable risk factors commonly present at baseline were physical inactivity (89%), low mental/cognitive activity (50%), low social engagement (39%), hypertension (39%) and high alcohol consumption (39%). The mean body mass index of participants was 28.3 (SD: 4.2) and the total serum cholesterol was 5.4 mmol/L (SD: 1.2).ConclusionsBaseline lifestyle and clinical measurements showed successful recruitment of participants with sufficient potential for prevention. Results of FINGER-NL will provide further insight into the efficacy of a multidomain lifestyle intervention to prevent cognitive decline in older adults.Trial registrationClinicalTrials.gov (ID: NCT05256199)/2022–01-11.

Postpartum life interventions to prevent type 2 diabetes in women with gestational diabetes: A systematic review and meta-analysis.

Type 2 diabetes mellitus is a major metabolic disease that seriously endangers life and health, but women with gestational diabetes mellitus are at increased risk for developing type 2 diabetes mellitus. This study aimed to evaluate the effectiveness of postpartum lifestyle intervention on the prevention of type 2 diabetes mellitus, and the effect of lifestyle intervention on glycemic outcomes and anthropometric measures. We searched PubMed and other databases to retrieve articles published before May 21, 2023, on randomized controlled trials of postnatal lifestyle interventions (diet and/or physical activity) in women with gestational diabetes mellitus. We estimated the pooled odds ratios using fixed or random effects models and conducted a subgroup analysis of the different intervention methods to explore differences in the different lifestyle interventions. The review included 17 randomized controlled trials. Overall, lifestyle changes started after a pregnancy complicated by gestational diabetes mellitus an 11% (RR = 0.89; 95% CI: 0.74-1.07) reduction in diabetes risk; significant differences were found for weight (MD = -1.33; 95% CI: [-1.76; -0.89], P < 0.00001) body mass index (MD = -0.53; 95% CI: [-0.74, -0.32], P < 0.00001), and waist circumference change (MD = -1.38; 95% CI: [-2.12; -0.64], P = 0.0002) but not for fasting glucose (MD = -0.06; 95% CI: [-0.19; 0.06], P = 0.32), 2 h glucose (MD = -0.12; 95% CI: [-0.30; 0.06], P = 0.19), and hemoglobin A1c (MD = -0.11; 95% CI: [-0.23; 0.02], P = 0.09). Subgroup analyses showed no significant differences in the effects of different lifestyle interventions on the incidence of type 2 diabetes, blood glucose levels, and anthropometric parameters. Our comprehensive meta-analysis of lifestyle interventions can improve modifiable anthropometric measures in women with gestational diabetes. We need further research to provide more intensive lifestyle intervention, more scientific intervention methods, and to reduce the incidence of type 2 diabetes in patients with gestational diabetes.

Abstract PO2-25-12: Production of a bespoke muscle resistance exercise (MRE) programme for use in a future clinical trial, following a detailed patient engagement program (PEP) in patients with advanced breast cancer (ABC)

Abstract Background: MRE investigations in early breast cancer have been undertaken but there has been little evaluation in ABC. Cancer guidelines suggest the use of physical activity, including MRE, to improve fatigue (National Comprehensive Cancer Network, 2.2020; European Society of Medical Oncology 2020) but improvement in other outcomes in ABC is less clear. In clinical trials, adherence to exercise intervention has been a challenge and has hampered investigation of other outcomes and little data exists evaluating the possible reasons for this poor adherence and compliance. In preparation for an exercise component as part of lifestyle intervention trial in ABC, a PEP was undertaken to evaluate an on-line web-based exercise program. Results would support continued usage of the program or creation of a new program. Methods: A commercially available program was used containing a library of exercises created for multiple disease types. There was no voice over. Using an exercise science professional, 2 sets of muscular resistance exercise programmes were created (A &amp;B), selecting exercises for upper and lower limb major muscle groups. Set A and B differed , with A involving younger leaner demonstrators and B older, less lean. Volunteers were asked to view the sets and complete a survey. The results of the survey, involving 21 volunteers of which 43% were over 60 years and presented previously, indicated that the following main modifications were needed to a program: use of demonstrators similar to patient's habitus and use of a voice-over to guide exercises. A short test video was produced incorporating these and other visual changes and viewed by a focus group of four volunteers. Results: The focus group concluded that the new visual and audio changes would allow them to more easily perform the exercises and increase the likelihood of compliance compared to the on-line program. The group advised involvement of a more diverse demonstrator group and further improvements to the voice-over. A professionally produced video has now been made with all the above changes. Conclusions: This PEP indicates that is necessary to review exercise programmes with patients and not assume they are all suitable for use in clinical trials. We believe a PEP of this kind with the resultant bespoke video is the first produced involving patients with ABC. This video will now be evaluated in a much larger diverse PPE which will help the development of a national UK clinical trial of exercise in ABC. Citation Format: Amanda Clarke, Jennifer Glendenning, Glen Davison, Catherine Harper-Wynne. Production of a bespoke muscle resistance exercise (MRE) programme for use in a future clinical trial, following a detailed patient engagement program (PEP) in patients with advanced breast cancer (ABC) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-25-12.

Examination of eating competence in a geo-diverse sample with metabolic syndrome

Eating competence (EatC) is an intra-individual approach to eating attitudes and behaviors associated with greater well-being. EatC research has not included persons with confirmed metabolic syndrome (MetS). Therefore, EatC of persons with MetS was explored to identify unique associations and inform implementation of MetS lifestyle interventions using baseline data from a multisite, randomized trial of a 2-year lifestyle intervention with MetS. EatC, measured with the Satter Eating Competence Inventory 2.0 (ecSI 2.0™), was examined for relationships with bioclinical measures (e.g., blood pressure, lipids), medication use, BMI, waist circumference, fruit/vegetable intake, and psychosocial factors, (e.g., stress, mindfulness). Data were collected in person and video call by trained research personnel. EatC was examined as a continuous score and as a categorical variable with ecSI 2.0™ scores ≥ 32 considered eating competent. Participants (n = 618) were predominantly female (76%), White (74%), college educated (60%). Mean age was 55.5 ± 11 y. Mean ecSI 2.0™ was 29.9 ± 7.4 and 42% were eating competent. EatC was greater for males, persons who were older and food secure. Competent eaters (vs. non-eating competent) had lower waist circumference (112.7 ± 12.5 cm vs.116.8 ± 16.0 cm; P < 0.001) and BMI (35.0 ± 6.1 vs. 37.5 ± 7.3; P < 0.001). Serum triglycerides, HDL-cholesterol, fasting blood glucose, HbA1c, and blood pressure did not differ by EatC status. Compared to non-eating competent persons, competent eaters perceived less stress, were more mindful, indicated better physical function, and more habitual vegetable intake (all P < 0.001) and sensory awareness (P < 0.05). EatC in MetS paralleled the non-MetS profile. EatC was associated with a healthier psychosocial profile, waist circumference and BMI. Findings support further research to examine the mediational or moderating influence of EatC in the treatment of MetS.

Medical Nutrition Therapy, In-Person, or Telephone Group Lifestyle Intervention for Type 2 Diabetes? A Qualitative Study of Patient Perceptions and Treatment Preferences.

The purpose of the study was to explore the thoughts, feelings, motivations, and assignment preferences of community health center patients with type 2 diabetes considering participation in a 2-year lifestyle intervention trial aimed at weight loss and increased physical activity. The reasons for patients' delivery mode preferences were also explored to aid in the design of future interventions for controlled trials. Using structured telephone interview guides, 57 patients with type 2 diabetes receiving primary care at 3 community health centers affiliated with an academic medical center were interviewed regarding the perceived pros and cons of each of the 3 possible treatment assignments: telephone conference group, in-person group, or individual medical nutrition therapy. The interview data were organized using NVIVO and analyzed using content analysis. Findings on whether preferences varied by age, gender, or diabetes duration were also examined. Six categories related to patient treatment preferences were identified: (1) perception of time, (2) learning style, (3) comfort, (4) prior experience with weight loss programs and conference calls, (5) desire for support/idea exchange, and (6) accountability. Preferences did not seem to vary by age, gender, or diabetes duration. Key factors influencing preference of treatment assignment included schedule demands, belief about learning style, and past experiences. These findings demonstrate the importance of having a variety of nutrition and lifestyle treatment options available to meet the needs of people with type 2 diabetes.

A meta-analysis of healthy lifestyle interventions addressing quality of life of cancer survivors in the post treatment phase.

This study's primary aim was to investigate whether including a mental health component to healthy lifestyle interventions are associated with greater effects on quality of life (QoL) for post-treatment cancer survivors than addressing physical activity and/or nutrition alone. PsycINFO, Scopus, Medline, CINAHL, and Google Scholar were searched to identify randomised control trials of healthy lifestyle interventions for post-treatment cancer survivors, with a usual care or waitlist control, and measured QoL. Meta-analyses quantified the effects of interventions vs controls at post-treatment on total QoL, physical, emotional, and social well-being. Subgroup analyses compared interventions with vs without a mental health component, modes of delivery, and duration. The quality of the included studies was assessed using the Cochrane Risk of Bias 2. Eighty-eight papers evaluating 110 interventions were included: 66 effect sizes were extracted for meta-analysis, and 22 papers were narratively synthesised. The pooled effect size demonstrated a small, significant effect of healthy lifestyle interventions in comparison to control for all QoL outcomes (total g = 0.32, p >.001; physical g = 0.19, p = 0.05; emotional g = 0.20, p >.001; social g = 0.18, p = 0.01). There was no significant difference between interventions with vs without a mental health component. Face-to-face delivered interventions were associated with greater total QoL and physical well-being compared to other modalities. Interventions delivered ≤12 weeks were associated with greater physical well-being than those delivered ≥13 weeks. Overall, studies had substantial levels of heterogeneity and 55.9% demonstrated high risk of bias. Participating in a healthy lifestyle intervention following cancer treatment improves QoL. Few trials addressed mental health or evaluated online or telephone modalities; future research should develop and evaluate interventions that utilise these features. Brief healthy lifestyle interventions can be recommended for cancer survivors, particularly those interested in improving physical well-being.

Perceived stress and progression of cardiometabolic risk factors among South Asians with prediabetes in a lifestyle intervention trial

AimsTo examine associations between perceived stress and cardiometabolic risk factors in South Asians with prediabetes and assess whether a diabetes prevention program mitigates the impact of stress on cardiometabolic health. MethodsWe conducted a secondary analysis of the Diabetes Community Lifestyle Improvement Program, a lifestyle modification trial for diabetes prevention in India (n = 564). Indicators for cardiometabolic health (weight, waist circumference, blood pressure, glucose, HbA1c, and lipids) were measured at each visit while perceived stress was assessed via questionnaire at baseline. Multivariable linear regression assessed associations between stress and cardiometabolic parameters at baseline and 3-year follow up. ResultsAt baseline, perceived stress was associated with higher weight (b=0.16; 95% CI: 0.04, 0.29) and waist circumference (b=0.11; 95% CI: 0.01, 0.21) but lower 30-minute postload glucose (b=−0.44; 95% CI: −0.76, −0.14) and LDL cholesterol (b=−0.40; 95% CI: −0.76, −0.03). Over the study period, perceived stress was associated with weight gain (b=0.20; 95% CI: 0.07, 0.33) and increased waist circumference (b=0.14; 95% CI: 0.04, 0.24). Additionally, higher perceived stress was associated with lower HDL cholesterol among the control arm (pinteraction = 0.02). ConclusionsBaseline stress was associated with negative cardiometabolic risk factor outcomes over time in those with prediabetes.

Early-life family meal participation and anthropometric measures at 4 years of age.

Early-life family meal participation has been associated with several aspects of nutritional health, but longitudinal associations with linear growth have not yet been investigated. The aim of this study was to investigate whether family meal participation at 12 months of age associates with anthropometric measures 3 years later. We used follow-up data from children born to mothers in the Norwegian Fit for Delivery trial (NFFD) and included 368 first-borns with dietary and anthropometric data at 12 months and 4 years of age. We treated the sample as a cohort and conducted subgroup analyses by randomization status. A family meal participation score was used as exposure, and weight, height, and body mass index (BMI) as outcomes in crude and multivariable linear regression models adjusted for maternal education, randomization status, and child sex.Higher family meal participation score at 12 months was positively associated with length at 12 months (B = 0.198, 95% CI 0.028, 0.367, p = 0.022) and 4 years (B = 0.283, 95% CI 0.011, 0.555, p = 0.042) in multivariable models. After additional adjustment for maternal height the associations attenuated and were no longer significant. An inverse association with BMI at 4 years of age was observed in children born to mothers that had been exposed to the NFFD intervention (B = -0.144, 95% CI -0.275, -0.014, p = 0.030), but attenuated after adjustment for maternal BMI.The longitudinal association observed between early family meal participation and child height was largely explained by maternal height. The relationship with BMI differed according to maternal participation in a lifestyle intervention trial during pregnancy.

"Simply complicated": Uncovering the processes of lifestyle behavior change among college and university students with access to a digital multiple lifestyle intervention.

One approach to promoting healthy lifestyle behaviors is to target students with digital interventions. One of these is the digital intervention Buddy. This study aimed to understand why college and university students' chose to participate in a digital multiple lifestyle behavior intervention trial (Buddy), and their subsequent experiences of the behavior-change process. College and university students taking part in a trial of the Buddy intervention were individually interviewed after completing the 4-month intervention. Participants were guided to narrate their experiences and actions that followed signing up. Altogether, 50 interviews were conducted via telephone. The verbatim transcribed texts were analyzed qualitatively. The analysis generated seven personas, which illustrated the students' different levels of engagement with the intervention and the behavior-change process. These were: the Occupied, the Kickstarter, the Aimless, the Reflective, the Goal-oriented, the Compliant, and the Personally developed. Buddy worked best for students who had clear ideas about what they wanted to change and why, and who were aware of their needs, and those who could translate information and reflection into action and had the mental and physical energy needed to make changes. The progress of behavior change depends on the interaction between the digital mode of delivery, the intervention materials of Buddy, the individual's expectations, needs, and skills, and their current life situation. This suggests that designing lifestyle interventions could benefit from more often considering the various personas' different intentions, knowledge, and contexts. By doing so, interventions are likely to emerge that can better match different needs in the target population.

THE IMPACT OF GROUP-LED YOGA AND MINDFULNESS ON MENTAL AND PHYSICAL HEALTH IN SOUTH ASIAN WOMEN

Abstract One in five South Asians (people from India, Pakistan, and Bangladesh) living in the U.S. report experiencing a mental illness, with women reporting a three-fold greater risk of distress than men. South Asian women commonly interpret mental health symptoms as physical illnesses and resist seeking medical help. Yoga is a multifaceted, effective practice promoting well-being by integrating mind and body. This study aims to determine the feasibility and impact of a 12-week (Jan-April 2023) yoga and mindfulness intervention on mental and physical health outcomes in South Asian women. Thirty community-dwelling South Asian immigrant women, age ≥45 years were recruited to complete weekly 90-minute sessions of Ashtanga yoga including meditation and mindfulness practice. We are currently reporting baseline and 6-week data of mindfulness and physical activity self-reported questionnaires as the intervention is ongoing, but 12-week data will be available for the final presentation. At baseline, participants were 53±6 years old and a majority (80%) were overweight/obese with BMI ≥25kg/m2. At 6 weeks, twenty-eight (93%) participants continued with the study and twenty-five (83%) attended ≥4 of the 6 sessions. By 6 weeks, participants’ scores improved on Five Facet Mindfulness by 17% (p&amp;lt; 0.001) and Godin Leisure-Time Exercise by 15% (p&amp;gt;0.05) from baseline. These results suggest the preliminary feasibility, retention, and potential impact of the intervention on mental health outcomes in this population. Future directions include developing a large-scale, randomized lifestyle intervention trial to delay/manage mental health outcomes in South Asian women of all ages.

Innovative recruitment strategies for a multi‐domain lifestyle intervention trial (FINGER‐NL) via the Dutch Brain Research Registry

AbstractBackgroundFinding eligible participants for dementia prevention trials is challenging, resulting in prolonged recruitment periods, underpowered studies, and excessive costs. The Dutch Brain Research Registry (DBRR) is an online platform to facilitate recruitment of research participants. We evaluated different recruitment strategies with the ambition to optimize recruitment for the multi‐domain lifestyle intervention trial FINGER‐NL.MethodDBRR registrants were prescreened for FINGER‐NL based on available profile information. Potentially eligible registrants received an automatic study invitation. Those interested were contacted for additional telephonic screening and, if eligible, included in the trial. Five recruitment strategies within 2022 were executed with the goal to increase the number of DBRR registrants: 1) a paid Facebook‐campaign, 2) referral via (patient)‐organizations, 3) newspaper articles, 4) live‐events, and 5) national television appearance (W.F&amp;E.S.). Recruitment source was traced (online; UTM tags) and/or reported by the participant. For most recruitment strategies, we involved a nationally well‐known ambassador (E.S.) who advocates a healthy lifestyle to improve brain‐health (Figure 1). For each strategy, we described the number of individuals registered, eligible and included in FINGER‐NL. We calculated efficiency (%eligible/prescreened) as a reflection of the proportion of eligible participants reached, and effectiveness (%included/registered) as a reflection of the proportion of participants included in FINGER‐NLResultIn 2022, the DBRR recruited 11234 new registrants. The highest numbers of registrants and highest number of inclusions were reached with national television appearance and the Facebook‐campaign (Table 1). In particular, the Facebook advertisement with a lifestyle theme and well‐known ambassador outperformed all other advertisements in number of registrations (Figure 1). After initial prescreening, between 18‐35% of registrants were eligible. Most efficient were national television and the Facebook‐campaign. Between 4‐12% of new registrants were included in the trial. Most effective strategies were national television appearance and referrals via patient‐organizationsConclusionOur results show that mass‐media, i.e. tailor‐made Facebook‐campaigns, national television appearance and events, are efficient ways to reach large numbers of eligible participants, especially when well‐known ambassador(s) were included. Recruitment strategies with detailed information about in‐ and exclusion of the trial are most effective. The DBRR provides an efficient and effective recruitment and prescreening process for the FINGER‐NL trial.

Virtual Design of the Brain Health Support Program and CAN‐THUMBS UP

AbstractBackgroundModifiable lifestyle factors account for ∼40% of the population attributable risk of dementia. This provides a strong rationale to develop remotely administered, personally tailored, home‐based interventions to reduce these risk factors. CAN‐THUMBS UP (CTU) is a fully remote program that has enrolled a cohort of individuals at risk of dementia, developed an interactive online educational intervention to address personalized risk factors and their modification, and supports an open platform trial to test and compare the efficacy of multidomain interventions. CTU is reaching a broader geography with potential for inclusion of more representative research populations and with an easier and less demanding participant experience.MethodCTU’s two research intervention programs include: a) The Brain Health Support Program (BHSP) with individuals at increased risk of dementia participating in the Brain Health PRO, a 12‐month online educational program which focuses on lifestyle and dementia risk factors; b) Synchronizing, Exercises and Remedies to Gain Cognition (SYNERGIC), a clinical trial intervention platform whose RCTs are investigating personalized multidomain interventions including those administered fully remotely. In SYNERGIC‐2, the BHPro educational intervention is used as an active control to a more personalized and tailored interventional approach. CTU programs are informed by initial pilot studies, have extensive community input, and incorporate innovative features including an interactive E‐consent platform, remote cognitive testing, wearable technology for sleep and activity monitoring, and home saliva collection for genomics.ResultTarget enrollment of 350 participants in BHSP has been rapidly achieved within 8 months utilizing geotargeted mailing and a coordinated national media campaign. Participants are recruited from all regions of Canada. Pilot studies demonstrated the feasibility of conducting a 100% remote study with high rates of participant satisfaction and completion rates across various virtual outcomes. Results of each of these components of the remote program will be detailed in this FRS.ConclusionCTU demonstrates the feasibility and high rate of participant acceptance in fully remote, comprehensive, online programs that include an educational intervention as well as fully remote, multi‐domain lifestyle intervention trials. The adoption of the various technologies has exceeded expectations and supports further clinical trial development with this approach.

The association of race, sex, and neighborhood disadvantage with baroreflex sensitivity in the U.S. POINTER Neurovascular ancillary study

AbstractBackgroundThe arterial baroreflex maintains stable blood flow to the brain. Reduced baroreflex sensitivity for modulation of heart rate (BRS) has been observed in patients with Alzheimer’s disease (AD) and mild cognitive impairment and may be impacted by race, ethnicity, sex, and socioeconomic factors such as the Area Deprivation Index (ADI), a validated, neighborhood‐level composite index that incorporates 17 social determinants of health. However, these relationships have not been well described.MethodThis study utilized baseline data from 196 participants enrolled in the U.S. POINTER Neurovascular study, an ancillary to the parent U.S. POINTER multi‐site lifestyle intervention trial that adds assessments of autonomic function and vascular structure and function. BRS was calculated from continuous blood pressure and electrocardiogram recording using the slope of the regression line between changes in systolic blood pressure and RR interval values in the same direction, with higher BRS indicating better autonomic function. ADI scores ranging from 1 to 10 were calculated using 9‐digit zip codes, with 10 indicating the greatest disadvantage. Analysis of variance and linear regression were used to evaluate associations between measures of interest.ResultThe average age of the study population was 67.9 ± 5.4 years, 64 (17%) were males, and 60 (30.6%) identified as people of color (POC). Overall, the mean BRS was 9.2 ± 4.6 ms/mmHg, and the average ADI score was 4.56 ± 2.69 (range: 1 to 10), corresponding to a national ADI percentile of 40.7 ± 26.1 (range: 3 to 100). Less than a quarter of participants (n = 42, 21.4%) had an ADI percentile &gt;67, indicating a moderate to high level of neighborhood disadvantage. White participants had lower BRS compared to POC (8.60 ± 4.49 vs. 10.60 ± 4.61 ms/mmHg, p = 0.0048). In a multiple regression model adjusting for demographics and ADI, sex (p = 0.0283), race and ethnicity (p = 0.0049), and education (p = 0.0196) were significantly associated with BRS, indicating better autonomic function in men, POC, and those with higher education. ADI was not associated with BRS.ConclusionRace, ethnicity, and education impact autonomic function. Further investigations are needed to assess the impact of other demographic and socioeconomic factors on neurovascular health.