Behavioral weight loss in emerging adults: Design and rationale for the Richmond Emerging Adults Choosing Health (REACH) randomized clinical trial

LaRose, Jessica Gokee; Leahey, Tricia M.; Lanoye, Autumn; Bean, Melanie K.; Tate, Deborah F.; Fava, Joseph L.; Evans, Ronald K.; Wickham, Edmond P.; Henderson, Megan M.; Hatley, Karen E.; Diamond, Molly

doi:10.1016/j.cct.2021.106426

Cited by 4 publications

(20 citation statements)

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“…A sample size of 381 was determined using an a priori power calculation; using estimates of variability from our pilot trials, we had 90% power to detect a clinically meaningful difference between groups, allowing for a 15% attrition rate and adjusting for 3 planned group comparisons. 30 The single-site trial was conducted in Richmond, Virginia, and funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. Enrollment occurred from February 2, 2016, to February 5, 2019; the trial was closed to accrual after reaching the predetermined sample size, and follow-up assessments continued through February 8, 2020 (Figure 1).…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…Study design and methods have been described elsewhere. 30 Participants were recruited using a multimethod approach spanning digital, social media, radio, print, and in-person outlets.…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…Those appearing to be eligible were invited to an orientation session followed by an informed consent process, culminating in written consent. 30 The REACH trial enrolled individuals aged 18 to 25 years with a BMI of 25 to 45. Exclusion criteria 30 centered on safety (eg, ability to engage in physical activity, no history of anorexia or bulimia or recent compensatory behaviors), with some exclusions for confounding (eg, taking weight loss medications) and practical considerations that would interfere with potential intervention benefit (eg, lack of consistent internet access).…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…The conceptual model and interventions have been described in detail. 30 Participants received the same core intervention grounded in behavioral self-regulation [31][32][33] that was adapted to meet the practical, developmental, and psychosocial needs of emerging adults, including changes to content, delivery mode, and increased personalization. 8,30 The core intervention included 1 group kickoff session (approximately 90 minutes) and 1 individual session to personalize goals (approximately 30 minutes), followed by a digital platform.…”

Section: Interventionmentioning

confidence: 99%

“…The second approach was rooted in self-determination theory (SDT) [27][28][29] and sought to enhance values-driven lifestyle change and support autonomy, competence, and relatedness. We report findings from a comparative efficacy trial 30 testing these lifestyle interventions on weight change at 6 months (primary outcome), as well as secondary cardiometabolic outcomes, including the proportion of participants achieving a weight loss of 5% or more, BMI, waist circumference, body fat, and blood pressure. Based on pilot evidence, 15,22 we hypothesized that both motivational enhancement groups would experience greater weight loss compared with the group receiving only the adapted standard after treatment (6 months).…”

Section: Introductionmentioning

confidence: 99%

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Effect of a Lifestyle Intervention on Cardiometabolic Health Among Emerging Adults

et al. 2022

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ImportanceThe 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.ObjectiveTo 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 ParticipantsIn 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.InterventionsParticipants 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 MeasuresThe 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.ResultsAmong 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT02736981

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Section: Study Design and Participantsmentioning

confidence: 99%

“…Study design and methods have been described elsewhere. 30 Participants were recruited using a multimethod approach spanning digital, social media, radio, print, and in-person outlets.…”

Section: Study Design and Participantsmentioning

confidence: 99%