Examining sociodemographic and health-related characteristics as moderators of an mHealth intervention on physical activity outcomes in young adult cancer survivors.

PURPOSE: This study explored whether sociodemographic and health-related characteristics moderated mHealth PA intervention effects on total and moderate-to-vigorous physical activity (MVPA) at 6 months, relative to a self-help condition among young adult cancer survivors (YACS). METHODS: We conducted exploratory secondary analyses of data from a randomized controlled trial among 280 YACS. All participants received digital tools; intervention participants also received lessons, adaptive goals, tailored feedback, text messages, and Facebook prompts. Potential moderators were assessed in baseline questionnaires. PA was measured at baseline and 6 months with accelerometers. Linear model repeated measures analyses examined within- and between-group PA changes stratified by levels of potential moderator variables. RESULTS: Over 6 months, the intervention produced MVPA increases that were ≥ 30 min/week compared with the self-help among participants who were males (28.1 vs. -7.7, p = .0243), identified with racial/ethnic minority groups (35.2 vs. -8.0, p = .0006), had baseline BMI of 25-30 (25.4 vs. -7.2, p = .0034), or stage III/IV cancer diagnosis (26.0 vs. -6.8, p = .0041). Intervention participants who were ages 26-35, college graduates, married/living with a partner, had a solid tumor, or no baseline comorbidities had modest MVPA increases over 6 months compared to the self-help (ps = .0163-.0492). Baseline characteristics did not moderate intervention effects on total PA. CONCLUSIONS: The mHealth intervention was more effective than a self-help group at improving MVPA among subgroups of YACS defined by characteristics (sex, race, BMI, cancer stage) that may be useful for tailoring PA interventions. IMPLICATIONS FOR CANCER SURVIVORS: These potential moderators can guide future optimization of PA interventions for YACS. GOV IDENTIFIER: NCT03569605.

Frailty and comorbidities among young adult cancer survivors enrolled in an mHealth physical activity intervention trial.

PURPOSE: The physical frailty phenotype identifies individuals at risk for adverse health outcomes but has rarely been assessed among young adult cancer survivors (YACS). This study describes frailty status among YACS participating in a physical activity (PA) intervention trial. METHODS: YACS were categorized at baseline using the 5-item FRAIL scale: fatigue; weight loss; illness; ambulation; resistance. Chi-square tests compared frailty and non-cancer comorbidities by characteristics. Prevalence rates (PRs) for the independent associations between characteristics, frailty, and comorbidities were estimated using modified Poisson regression models. RESULTS: Among 280 YACS (82% female; mean (M) age = 33.4 ± 4.8 years, M=3.7 ± 2.4 years post-diagnosis), 11% frail, 17% prefrail; the most frequent criteria were fatigue (41%), resistance (38%), and ambulation (14%). Compared to BMI < 25, higher BMI was associated with increased likelihood of frailty (BMI 25-30, PR: 2.40, 95% CI: 1.38-4.17; BMI > 30, PR: 2.95, 95% CI: 1.71-5.08). Compared to 0, ≥ 30 min/week of moderate-to-vigorous PA was associated with reduced frailty (PR: 0.39, 95% CI: 0.25-0.60). Most YACS (55%) reported ≥ 1 comorbidity, most frequently depression (38%), thyroid condition (19%), and hypertension (10%). Comorbidities were more common for women (59% vs. 37%) and current/former smokers (PR: 1.71, 95% CI: 1.29-2.28). CONCLUSION: Prevalence of frailty and comorbidities in this sample was similar to other YACS cohorts and older adults without cancer and may be an indicator of accelerated aging and increased risk for poor outcomes. IMPLICATIONS FOR CANCER SURVIVORS: Assessment of frailty may help identify YACS at increased risk for adverse health outcomes.

"My wellbeing-their wellbeing "- An eHealth intervention for managing obesity in early care and education: Protocol for the Go NAPSACC Cares cluster randomized control trial.

BACKGROUND: To fully leverage the potential of the early care and education (ECE) setting for childhood obesity prevention, initiatives must not intervene solely at the organizational level, but rather they should also address the health needs of the ECE workers. Workers suffer disproportionately high rates of obesity, and have reported low confidence in modeling and promoting healthy eating and activity behaviors. However, information regarding the effectiveness of improving ECE workers' health behaviors or whether such improvements elicit meaningful change in the ECE environment and/or the children in their care is limited. METHOD: The proposed study will integrate a staff wellness intervention into a nationally recognized, ECE obesity prevention initiative (Go NAPSACC). Go NAPSACC+ Staff Wellness program will be assessed using a clustered randomized controlled trial including 84 ECE centers, 168 workers, and 672 2-5-year-old children. Centers will be randomly assigned to 1) standard "Go NAPSACC" or 2) Go NAPSACC+ Staff Wellness. Outcome measures will assess impact on dietary intake and PA behaviors of 2-5-year-old children at 6 months (primary aim) and 12 months. Secondarily, we will compare the impact of the intervention on centers' implementation of healthy weight practices and the effect on ECE workers' diet quality and PA at 6- and 12 months. DISCUSSION: This trial expects to increase our understanding of how ECE worker's personal health behaviors impact the health behaviors of the children in their care and the ECE environment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05656807, registered on 19 December 2022. Protocol version 1.0, 22 March 2023.

Creating an appetite awareness and lifestyle modification intervention for Black women at risk for binge eating disorder: A pilot open trial.

Despite the availability of evidence-based interventions to improve binge eating, Black women have some of the lowest rates of access to care for eating disorders. Innovation is needed to offer accessible and culturally relevant treatment options. To this end, using an open trial design, we investigated the feasibility and acceptability of a group-based, appetite awareness training (AAT) + lifestyle modification (LM) programme in Black women at risk for BED in a primary care setting. Participants (n = 20) were Black women recruited from a family medicine centre affiliated with a local public university, and who reported at least two binge eating episodes in the last 28 days. Participants completed a 16-session AAT + LM programme over 4 months. Key outcomes were objective binge eating (assessed by the EDE and the EDE-Q), body dissatisfaction, and weight change, all assessed at baseline, four (post-treatment) and 6 months (2-month follow-up). Ninety-five percent of participants completed assessments at post-treatment and attended nearly 60% of intervention sessions. Among completers (n = 19), body dissatisfaction and objective binge eating decreased from baseline to post-treatment and this decrease was maintained at the 2-month follow-up. In exit interviews, participants reported programme satisfaction. Providing training in appetite awareness combined with lifestyle modification principles may be useful in the treatment of body dissatisfaction and binge eating among Black women.

Frailty and Comorbidities Among Young Adult Cancer Survivors Enrolled in an mHealth Physical Activity Intervention Trial.

Purpose: The physical frailty phenotype identifies individuals at risk for adverse health outcomes but has rarely been assessed among young adult cancer survivors (YACS). This study describes frailty status among YACS participating in a PA intervention trial. Methods: YACS were categorized by frailty status at baseline using the 5-item FRAIL index: fatigue; weight loss; illness; ambulation; resistance. Chi-square tests compared frailty and comorbidities by characteristics. Prevalence rates (PRs) for the independent associations between characteristics, frailty, and comorbidities were estimated using modified Poisson regression models. Results: Among 280 YACS (82% female, M=33.4±4.8 years, M=3.7±2.4 years post-diagnosis), 14% had frailty, and 24% prefrailty; the most frequent criteria were fatigue (70%), resistance (38%), and ambulation (14%). Compared to BMI <25, higher BMI (BMI 25-30, PR: 1.65, 95% CI: 1.02-2.65; BMI > 30, PR: 2.36, 95% CI: 1.46-3.81) was associated with increased frailty status. Compared to 0, 1-50 minutes/week of moderate-to-vigorous PA was associated with reduced frailty (PR: 0.62, 95% CI: 0.43-0.90). Most YACS (55%) reported > 1 comorbidity, most frequently depression (38%), thyroid condition (19%), and hypertension (10%). Men were less likely to report comorbidities (PR: 0.63, 95% CI: 0.42-0.93). Current/former smokers (PR: 1.29, 95% CI: 1.01-1.64) were more likely to have comorbidities. Conclusion: Prevalence of frailty and comorbidities in this sample was similar to other YACS cohorts and may be an indicator of accelerated aging and increased risk for poor outcomes. Implications for Cancer Survivors: Assessment of frailty may help identify YACS at risk for adverse health outcomes.

Physical activity maintenance among young adult cancer survivors in an mHealth intervention: Twelve-month outcomes from the IMPACT randomized controlled trial.

BACKGROUND: Most physical activity (PA) interventions in young adult cancer survivors (YACS) have focused on short-term outcomes without evaluating longer-term outcomes and PA maintenance. This study examined the effects of an mHealth PA intervention at 12 months, after 6 months of tapered contacts, relative to a self-help group among 280 YACS. METHODS: YACS participated in a 12-month randomized trial that compared self-help and intervention groups. All participants received an activity tracker, smart scale, individual videochat session, and access to a condition-specific Facebook group. Intervention participants also received lessons, tailored feedback, adaptive goal setting, text messages, and Facebook prompts for 6 months, followed by tapered contacts. Accelerometer-measured and self-reported PA (total [primary outcome], moderate-to-vigorous [MVPA], light, steps, sedentary behaviors) were collected at baseline, 6, and 12 months. Generalized estimating equation analyses evaluated group effects on outcomes from baseline to 12 months. RESULTS: From baseline to 12 months, there were no between- or within-group differences in accelerometer-measured total PA min/week, while increases in self-reported total PA were greater in the intervention versus self-help group (mean difference = +55.8 min/week [95% CI, 6.0-105.6], p = 0.028). Over 12 months, both groups increased accelerometer-measured MVPA (intervention: +22.5 min/week [95% CI, 8.8-36.2] vs. self-help: +13.9 min/week [95% CI, 3.0-24.9]; p = 0.34), with no between-group differences. Both groups maintained accelerometer-measured and self-reported PA (total, MVPA) from 6 to 12 months. At 12 months, more intervention participants reported meeting national PA guidelines than self-help participants (47.9% vs. 33.1%, RR = 1.45, p = 0.02). CONCLUSION: The intervention was not more effective than the self-help group at increasing accelerometer-measured total PA over 12 months. Both groups maintained PA from 6 to 12 months. Digital approaches have potential for promoting sustained PA participation in YACS, but additional research is needed to identify what strategies work for whom, and under what conditions.

Life events and stress among young adults in weight gain prevention trial.

OBJECTIVE: Young adults (YAs) are at high risk for weight gain and show high variability in treatment response. Life events and high perceived stress are common in YAs and could drive less favorable outcomes. The goal was to examine whether life events and stress were related to program engagement and weight outcomes in a weight gain prevention trial for YAs. METHOD: Secondary analysis from the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized clinical trial (N = 599, 18-35 years, BMI 21-30 kg/m²). Both intervention arms received 10 in-person sessions over 4 months, with long-term contact via web and SMS. Participants completed the CARDIA life events survey and Cohen Perceived Stress Scale-4 at 0 and 4 months; weight was objectively measured at 0, 4 months, and 1, 2, 3, and 4 years. RESULTS: Participants who experienced more life events prior to study entry had lower session attendance (p < .01) and retention (p < .01), although no differences in weight outcomes were observed (p = .39). Baseline perceived stress followed a similar pattern. Participants who experienced more life events and higher perceived stress during the initial in-person program (0-4 months) appeared to experience less favorable weight outcomes long-term (p = .05 for life events, p = .04 for stress). Very few associations differed by treatment arm. CONCLUSIONS: Experiencing more life events and stress was negatively associated with program engagement and may impair long-term weight outcomes for YAs. Future work should consider identifying YAs at highest risk and tailoring interventions to better meet their needs. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Identifying the behavior change techniques used in obesity interventions: An example from the EARLY trials.

Objective: The dissemination of effective obesity interventions requires the documentation of key elements of the intervention. But outcome papers and other published manuscripts often lack detail that allow the replication of the intervention. The Behavior Change Technique (BCT) Taxonomy (BCTTv1) is a widely used approach to identify key elements of an intervention study. This study compares the extent to which BCTs and domains identified in studies' intervention protocol are concordant with detail from corresponding intervention design and study outcome papers. Methods: Data come from four obesity interventions with complete intervention protocols as well as published intervention design and outcome papers. The number of domains and BCTs was calculated for each treatment arm and stratified by coding source. Emphasis of domains and BCTs was determined using an Analytical Hierarchy Process (AHP). Results: A review of each study's intervention protocol showed the mean number of domains and BCTs used in treatment arms as 11.8 and 26.7, respectively. Primary outcome papers had a mean loss of 34% of the reported domains and 43% of BCTS as compared with intervention protocl. Design papers showed a loss of 11% and 21% of domains and BCTs, respectively. Conclusions: The results confirm the limitations of using the BCTTv1 coding of outcome papers to describe obesity-related interventions. The results also highlight the need for mechanisms that allow for a full description of intervention content such as inclusion in a supplemental section of an online journal or the use of intervention-focused consort guidelines.

Outcomes of a Caregiver-Focused Short Message Service (SMS) Intervention to Reduce Intake of Sugar-Sweetened Beverages in Rural Caregivers and Adolescents.

This study examined enrollment, retention, engagement, and behavior changes from a caregiver short message service (SMS) component of a larger school-based sugar-sweetened beverage (SSB) reduction intervention. Over 22 weeks, caregivers of seventh graders in 10 Appalachian middle schools received a two-way SMS Baseline Assessment and four monthly follow-up assessments to report their and their child's SSB intake and select a personalized strategy topic. Between assessments, caregivers received two weekly one-way messages: one information or infographic message and one strategy message. Of 1873 caregivers, 542 (29%) enrolled by completing the SMS Baseline Assessment. Three-quarters completed Assessments 2-5, with 84% retained at Assessment 5. Reminders, used to encourage adherence, improved completion by 19-40%, with 18-33% completing after the first two reminders. Most caregivers (72-93%) selected a personalized strategy and an average of 28% viewed infographic messages. Between Baseline and Assessment 5, daily SSB intake frequency significantly (p < 0.01) declined for caregivers (-0.32 (0.03), effect size (ES) = 0.51) and children (-0.26 (0.01), ES = 0.53). Effect sizes increased when limited to participants who consumed SSB twice or more per week (caregivers ES = 0.65, children ES = 0.67). Findings indicate that an SMS-delivered intervention is promising for engaging rural caregivers of middle school students and improving SSB behaviors.

Motivating Weight Loss Among Black Adults in Relationships: Recommendations for Weight Loss Interventions.

BACKGROUND: Black men and women have the highest rates of obesity in the United States. Behavioral weight loss programs incorporating intimate partners may be effective in combating obesity among this population. Yet, current participation in these programs is low. Identifying motivations and triggers to weight loss may provide insight in designing programs to increase participation. AIM: To determine triggers and motivations for weight loss among Black men and women in committed relationships to inform development of weight loss interventions. METHOD: Twenty semi-structured interviews, based on an integrated theoretical framework of interdependence and communal coping and the social cognitive theory, were conducted among Black heterosexual couples where one or both individuals intentionally lost ≥5% of their body weight in the last 6 months in a metropolitan region in a southern state. Interviews were transcribed and coded. Themes were identified following multi-rater coding and direct and conventional content analysis. Recommendations were developed from emergent themes. RESULTS: Among individuals with recent weight loss, personal relevancy and awareness (health awareness and self-awareness) were identified as personal triggers for weight loss initiation. Health concerns and appearance were general motivations among the total sample. CONCLUSION: Emphasizing the impact of weight on daily functioning and quality of life, and increasing awareness of personal weight status and health consequences, may increase weight loss initiation and participation in weight loss programs among Black men and women in committed relationships. Findings also highlight strategies to improve recruitment and retention and guide intervention development and implementation for this population.

Effect of an mHealth intervention on physical activity outcomes among young adult cancer survivors: The IMPACT randomized controlled trial.

BACKGROUND: Physical inactivity is common in young adult cancer survivors (YACS), but evidence regarding effects of physical activity (PA) interventions among YACS is limited. The IMproving Physical Activity after Cancer Treatment (IMPACT) trial evaluated a theory-based mobile PA intervention on total PA minutes/week (primary) and secondary outcomes (moderate-to-vigorous PA [MVPA], light PA, steps, sedentary behaviors) at 6 months in YACS. METHODS: YACS (N = 280) were randomized to an intervention group or self-help group. All participants received digital tools (activity tracker, smart scale, access to arm-specific Facebook group) and an individual video chat session. Intervention participants also received a 6-month program with behavioral lessons, adaptive goal-setting, tailored feedback, tailored text messages, and Facebook prompts. PA was assessed via accelerometry and questionnaires at baseline and 6 months. Generalized estimating equation analyses tested between-group differences in changes over time. RESULTS: Of 280 YACS, 251 (90%) completed the 6-month accelerometry measures. Accelerometer-measured total PA minutes/week changed from 1974.26 at baseline to 2024.34 at 6 months in the intervention (mean change, 55.14 [95% CI, -40.91 to 151.19]) and from 1814.93 to 1877.68 in the self-help group (40.94 [95% CI, -62.14 to 144.02]; between-group p = .84). Increases in MVPA were +24.67 minutes/week (95% CI, 14.77-34.57) in the intervention versus +11.41 minutes/week in the self-help (95% CI, 1.44-21.38; between-group p = .07). CONCLUSION: Although the intervention did not result in significant differences in total PA, the increase in MVPA relative to the self-help group might be associated with important health benefits. Future research should examine moderators to identify for whom, and under what conditions, the intervention might be effective. CLINICALTRIALS: gov Identifier: NCT03569605. PLAIN LANGUAGE SUMMARY: Physical inactivity is common in young adult cancer survivors. However, few interventions have focused on helping young adult cancer survivors to get more physical activity. The IMproving Physical Activity after Cancer Treatment trial compared a mobile health physical activity intervention with a self-help group on total amount of physical activity at 6 months in a nationwide sample of young adult cancer survivors. Intervention participants did not improve their total amount of physical activity, but they did increase their moderate-to-vigorous intensity physical activity by twice as much as the self-help participants. This increase in activity may be associated with health benefits.

Earlier treatment in adults with high lifetime risk of cardiovascular diseases: What prevention trials are feasible and could change clinical practice? Report of a National Heart, Lung, and Blood Institute (NHLBI) Workshop.

More than half of U.S. young adults have low ten-year but high lifetime risk of cardiovascular disease (CVD). Improving primary prevention in young adulthood may help reduce persistent CVD disparities and overall CVD morbidity and mortality. The National Heart, Lung, and Blood Institute (NHLBI) convened a workshop in 2021 to identify potential trial opportunities in CVD prevention in young adults. The workshop identified promising interventions that could be tested, including interventions that focus on a single cardiovascular risk factor (e.g., lipids or inflammation) to multiple risk factor interventions (e.g., multicomponent lifestyle interventions or fixed-low dose combination of medications). Given the sample size and duration for a trial with hard endpoints, more research is needed on the utility of intermediate endpoints identified noninvasively such as subclinical coronary atherosclerosis as a surrogate endpoint. For now, clinical outcomes trials with hard endpoints will more likely change clinical practice. Trial efficiency depends on accurate identification of high-risk young adults, which can potentially be done using traditional risk equations, coronary artery calcium screening, computerized tomography coronary angiography, and polygenic risk scores. Trials in young adults should include enhanced recruitment strategies with intense community engagement to enroll a trial population that is racially, ethnically, geographically, and socially diverse. Despite the challenges in conducting large prevention trials in young adults, recent advances including innovation in clinical trial conduct, new therapies and successful interventions in older populations, and an increasing recognition of a lifespan approach to risk assessment have made such trials more feasible than ever. Disclosures: The views expressed in this manuscript are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services.

A cluster-randomized controlled trial of automated internet weight-loss programs in primary care: Role of automated provider feedback.

OBJECTIVE: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity. METHODS: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months. RESULTS: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP. CONCLUSIONS: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence.

Parent and child dietary changes in a 6-month mobile-delivered weight loss intervention with tailored messaging for parents.

Objective: To examine changes in parent and child dietary intake, associations between program adherence and parent dietary changes, and the association between parent and child dietary changes in a mobile-delivered weight loss intervention for parents with personalized messaging. Methods: Adults with overweight or obesity and who had a child aged 2-12 in the home were recruited for a randomized controlled trial comparing two types of dietary monitoring: calorie monitoring (Standard, n = 37) or "red" food monitoring (Simplified, n = 35). Parents received an intervention delivered via a smartphone application with lessons, text messages, and weekly personalized feedback, and self-monitoring of diet, activity, and weight. To measure associations between parent and child dietary changes, two 24-h recalls for parents and children at baseline and 6 months measured average daily calories, percent of calories from fat, vegetables, fruit, protein, dairy, whole grains, refined grains, added sugars, percent of calories from added sugars, and total Healthy Eating Index-2015 score. Results: Higher parent engagement was associated with lower parent percent of calories from fat, and greater days meeting the dietary goal was associated with lower parent daily calories and refined grains. Adjusting for child age, number of children in the home, parent baseline BMI, and treatment group, there were significant positive associations between parent and child daily calories, whole grains, and refined grains. Parent-child dietary associations were not moderated by treatment group. Conclusions: These results suggest that parent dietary changes in an adult weight loss program may indirectly influence child diet.

Effect of a Lifestyle Intervention on Cardiometabolic Health Among Emerging Adults: A Randomized Clinical Trial.

Importance: The prevalence of obesity has increased substantially among emerging adults, yet no previous large-scale behavioral weight loss trials have been conducted among this age group. Objective: To test the effect of 2 theory-based motivational enhancements on weight loss within a primarily digital lifestyle intervention designed for emerging adults. Design, Setting, and Participants: In this randomized clinical trial conducted at an academic medical research center, 382 participants aged 18 to 25 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45 were enrolled between February 2, 2016, and February 6, 2019. Data collection was completed February 8, 2020. Analysis was performed on an intention-to-treat basis. Interventions: Participants were randomized to 1 of 3 groups: developmentally adapted behavioral weight loss (aBWL), aBWL plus behavioral economics (aBWL + BE), or aBWL plus self-determination theory (aBWL + SDT). All groups received a 6-month intervention with 1 group session, 1 individual session, and a digital platform (digital tools for self-monitoring, weekly lessons, tailored feedback, text messages, and optional social media). The aBWL + BE group received modest financial incentives for self-monitoring and weight loss; the aBWL + SDT group received optional experiential classes. Coaching and message framing varied by group. Main Outcomes and Measures: The primary outcome was mean (SE) weight change (in kilograms) at 6 months. Secondary outcomes included proportion of participants achieving weight loss of 5% or more, percentage weight change, waist circumference, body composition, and blood pressure. Results: Among the 382 participants (mean [SD] age, 21.9 [2.2] years), 316 (82.7%) were female, mean (SD) BMI was 33.5 (4.9), 222 (58.1%) were of underrepresented race and/or ethnicity, and 320 (83.8%) were retained at the primary end point. There was a significant time effect for mean (SE) weight loss (-3.22 [0.55] kg in the aBWL group; -3.47 [0.55] kg in the aBWL + BE group; and -3.40 [0.53] kg in the aBWL + SDT group; all P < .001), but no between-group differences were observed (aBWL vs aBWL + BE: difference, -0.25 kg [95% CI, -1.79 to 1.29 kg]; P = .75; aBWL vs aBWL + SDT: difference, -0.18 kg [95% CI, -1.67 to 1.31 kg]; P = .81; and aBWL + SDT vs aBWL + BE: difference, 0.07 kg [95% CI, -1.45 to 1.59 kg]; P = .93). The proportion of participants achieving a weight loss of 5% or more was 40.0% in the aBWL group (50 of 125), 39.8% in the aBWL + BE group (51 of 128), and 44.2% in the aBWL + SDT group (57 of 129), which was not statistically different across groups (aBWL vs aBWL + BE, P = .89; aBWL vs aBWL + SDT, P = .45; aBWL + SDT vs aBWL + BE, P = .54). Parallel findings were observed for all secondary outcomes-clinically and statistically significant improvements with no differences between groups. Conclusions and Relevance: In this randomized clinical trial, all interventions produced clinically significant benefit, but neither of the motivational enhancements promoted greater reductions in adiposity compared with the developmentally adapted standard group. Continued efforts are needed to optimize lifestyle interventions for this high-risk population and determine which intervention works best for specific individuals based on sociodemographic and/or psychosocial characteristics. Trial Registration: ClinicalTrials.gov Identifier: NCT02736981.

Efficacy of a Commercial Weight Management Program Compared With a Do-It-Yourself Approach: A Randomized Clinical Trial.

Importance: Given the prevalence of obesity, accessible and effective treatment options are needed to manage obesity and its comorbid conditions. Commercial weight management programs are a potential solution to the lack of available treatment, providing greater access at lower cost than clinic-based approaches, but few commercial programs have been rigorously evaluated. Objective: To compare the differences in weight change between individuals randomly assigned to a commercial weight management program and those randomly assigned to a do-it-yourself (DIY) approach. Design, Setting, and Participants: This 1-year, randomized clinical trial conducted in the United States, Canada, and United Kingdom between June 19, 2018, and November 30, 2019, enrolled 373 adults aged 18 to 75 years with a body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 25 to 45. Assessors were blinded to treatment conditions. Interventions: A widely available commercial weight management program that included reduced requirements for dietary self-monitoring and recommendations for a variety of DIY approaches to weight loss. Main Outcomes and Measures: The primary outcomes were the difference in weight change between the 2 groups at 3 and 12 months. The a priori hypothesis was that the commercial program would result in greater weight loss than the DIY approach at 3 and 12 months. Analyses were performed on an intention-to-treat basis. Results: The study include 373 participants (272 women [72.9%]; mean [SD] BMI, 33.8 [5.2]; 77 [20.6%] aged 18-34 years, 74 [19.8%] aged 35-43 years, 82 [22.0%] aged 44-52 years, and 140 [37.5%] aged 53-75 years). At 12 months, retention rates were 88.8% (166 of 187) for the commercial weight management program group and 95.7% (178 of 186) for the DIY group. At 3 months, participants in the commercial program had a mean (SD) weight loss of -3.8 (4.1) kg vs -1.8 (3.7) kg among those in the DIY group. At 12 months, participants in the commercial program had a mean (SD) weight loss of -4.4 (7.3) kg vs -1.7 (7.3) kg among those in the DIY group. The mean difference between groups was -2.0 kg (97.5% CI, -2.9 to -1.1 kg) at 3 months (P < .001) and -2.6 kg (97.5% CI, -4.3 to -0.8 kg) at 12 months (P < .001). A greater percentage of participants in the commercial program group than participants in the DIY group achieved loss of 5% of body weight at both 3 months (40.7% [72 of 177] vs 18.6% [34 of 183]) and 12 months (42.8% [71 of 166] vs 24.7% [44 of 178]). Conclusions and Relevance: Adults randomly assigned to a commercial weight management program with reduced requirements for dietary self-monitoring lost more weight and were more likely to achieve weight loss of 5% at 3 and 12 months than adults following a DIY approach. This study contributes data on the efficacy of commercial weight management programs and DIY weight management approaches. Trial Registration: ClinicalTrials.gov Identifier: NCT03571893.

Persistent, High Levels of Social Jetlag Predict Poor Weight Outcomes in a Weight Gain Prevention Study for Young adults.

INTRODUCTION: Social jetlag (SJL), the discrepancy in sleep timing between weekdays and weekends, is associated with higher BMI and cardiometabolic risk and is common in young adults. We examined whether chronic SJL impacts weight gain in young adults participating in a weight gain prevention trial. METHODS: Young adults (n = 599, age 18-35; BMI: 21.0-30.9 kg/m2) completed assessments at 0, 4, 12, and 24 months. Multilevel mixed growth models were used to examine (1) associations between demographics and longitudinal SJL and (2) longitudinal SJL as a predictor of weight change and cardiometabolic outcomes. SJL was assessed as a continuous and clinically-significant dichotomous (< vs. ≥2 h) variable. RESULTS: 38% of participants had clinically-significant SJL at ≥ 1 timepoints (Baseline M ± SD = 1.3±0.89). Younger (b=-0.05, p < 0.001), female (b = 0.18, p = 0.037) and Black (compared to White, b = 0.23, p = 0.045) participants were more likely to have greater SJL. Individuals with high SJL (≥ 2 h; between-person effect) were more likely to have greater weight gain over 2 years (b = 0.05, p = 0.028). High SJL did not affect the rate of change in waist circumference or cardiometabolic markers over time. CONCLUSIONS: High SJL is associated with greater weight gain over time. Reducing SJL may positively impact weight status in young adults.

Uric acid as a predictor of weight gain and cardiometabolic health in the Study of Novel Approaches to Weight Gain Prevention (SNAP) study.

Young adulthood is often a period of substantial weight gain increasing risk for obesity and cardiometabolic disease. Uric acid (UA), a clinical marker of oxidative stress, is associated with cardiometabolic dysfunction in established CVD, type 2 diabetes, and CKD. Yet, few trials have examined UA as a predictor of cardiometabolic risk in young, healthy populations, particularly in the context of weight gain prevention intervention. The purpose of this ancillary study was to examine UA in the Study of Novel Approaches to Weight Gain Prevention (SNAP), a randomized, controlled trial of weight gain prevention strategies in young healthy adults. UA was examined as a predictor of weight and cardiometabolic outcomes over 6 years; the impact of weight gain prevention interventions on UA was also examined. We found that higher baseline UA was a significant predictor of less favorable BMI, triglycerides, HDL, glucose, insulin, and HOMA, independent of age, sex, baseline weight, baseline level of the outcome variable, and weight gain prevention intervention. Additionally, ≥1% weight loss was associated with lower UA. UA is a promising biomarker for future weight gain and cardiometabolic risk in young adults that may respond to weight gain prevention.Clinical trial registration: clinicaltrials.gov identifier NCT01183689.

Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention.

PURPOSE: Few studies have recruited young adult cancer survivors (YACS) from around the USA into remotely-delivered behavioral clinical trials. This study describes recruitment strategies used in the IMproving Physical Activity after Cancer Treatment (IMPACT) study, a 12-month randomized controlled trial of a mobile physical activity intervention for YACS. METHODS: We conducted formative work to guide development of recruitment messages and used a variety of methods and channels to recruit posttreatment YACS (diagnosed ages 18-39, participating in < 150 min/week of moderate-to-vigorous intensity activity). We used targeted social media advertisements, direct mailings, clinical referrals, and phone calls to potentially eligible individuals identified through local tumor registries. We also asked community organizations to share study information and advertized at a national conference for YACS. RESULTS: The final sample of 280 participants (23% identified as racial/ethnic minority individuals, 18% male, mean 33.4 ± 4.8 years) was recruited over a 14-month period. About 38% of those who completed initial screening online (n = 684) or via telephone (n = 63) were randomized. The top recruitment approach was unpaid social media, primarily via Facebook posts by organizations/friends (45%), while direct mail yielded 40.7% of participants. Other social media (paid advertisements, Twitter), email, clinic referrals, and conference advertisements each yielded 3% or fewer participants. The most cost-effective methods per participant recruited were unpaid social media posts and direct mailings. CONCLUSIONS: The IMPACT trial successfully met enrollment goals using a national strategy to recruit physically inactive YACS. Our approaches can inform recruitment planning for other remotely-delivered intervention trials enrolling YACS. TRIAL REGISTRATION: ClinicalTrials.gov NCT03569605 . Registered on 26 June 2018.

The Multi-Caregiver Role and Its Relationship to Behavioral Adherence and Weight Among Treatment Engaged Black Women.

PURPOSE: To examine the relationship between the multiple caregiver role and its perceived barriers to self-care on behavioral adherence in a weight loss intervention. DESIGN: A secondary analysis of data from a behavioral weight loss intervention. SETTING: The study was conducted in two cohorts from March 2016 to February 2017 at the University of North Carolina at Chapel Hill. SUBJECTS: Eighty-one Black women with overweight/obesity (age = 48.4 ± 10.9 years [M ± SD], BMI = 36.4 ± 4.5 kg/m2 [M ± SD]). MEASURES: Identification with the multiple caregiver role and barriers was assessed with the Multiple Caregiving Measurement Instrument. Weight was measured with a digital scale and height with a stadiometer. The Block food frequency questionnaire evaluated dietary intake. Moderate-to-vigorous physical activity (MVPA) was measured objectively with an accelerometer. Study adherence was measured by session attendance, self-weighing, and self-monitoring (diet and physical activity) frequency. ANALYSIS: Generalized linear models were used to examine the relationship between the multiple caregiver scales and the outcomes of interest, controlling for study arm, cohort, and income. Chi-square tests tested correlations. RESULTS: Greater identification with the multiple caregiver role was associated with decreased session attendance (ß = -.56 [SE = .27], P < .05) and a trend towards weight gain (ß = .36, [SE = .19], P = .07). Greater multiple caregiver barriers score predicted a decrease in fruit/vegetable intake (ß = -.17 [SE = .07], P < .05). All regression results are unstandardized. Negative correlations between multiple caregiver barriers and MVPA (r = -.24, P = .06) and daily self-weighing (r = -.19, P = .10) approached significance. CONCLUSIONS: Participants' identification with multiple caregiving role and barriers can reduce adherence, behavior and weight change. Interventions to address Black women's multiple roles and barriers during weight loss are needed to maximize outcomes.