Sequential Multiple Assignment Randomized Trial (SMART) to Construct Weight Loss Interventions for African American Adolescents

Abstract

Objective To develop an adaptive behavioral treatment for African American adolescents with obesity. Method In a sequential multiple assignment randomized trial, 181 youth ages 12 to 16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, non-responders to first phase treatment were re-randomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression Results There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for non-responders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. Conclusions More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population.

Recruitment Strategies and the Retention of Obese Urban Racial/Ethnic Minority Adolescents in Clinical Trials: The FIT Families Project, Michigan, 2010–2014

“…FIT Families was a 6-month sequential multiple assignment randomized trial (SMART) (18) focusing on weight loss among obese African American adolescents (19). Recruitment began in November 2010, the first data collection took place in January 2011, and the last data collection took place in March 2014.…”

“…Each participating family received $50 for completion of data collection at 3 points (baseline, 7 months, and 9 months) and $10 for completion of data collection at 3 months. Details on the intervention are described elsewhere (19). …”

“…Overview of sequential multiple assignment randomized trial (SMART) design (19) for the FIT Families study, Michigan, 2010–2014. The first randomization took place at baseline and the second at 3 months.…”

“…After research staff confirmed eligibility in person during the home visit, which included a screening for the potential participant’s level of safety in engaging in physical activity, the researcher obtained informed consent from the caregivers and assent from the adolescents. Because of the complex SMART study design, extra attention was paid to explain the 6 intervention arms to study participants (19). Differences between compensation for data collection and intervention visits were also explained.…”

Behavioral Economic Factors Related to Pediatric Obesity

“…Our team is investigating the role of RRV in basic research and as a moderator of intervention treatment effects in African American adolescents. In our sequential multiple assignment randomized trial (SMART), 54 African American adolescents (12-16 y/o) with obesity (BMI≥95 th percentile) completed 3 months of motivational interviewing plus skills building with their caregivers in their home or clinic (first randomization). Adolescents who did not lose at least 3% of their baseline body weight were re-randomized to complete three months of contingency management (reinforcement for weight loss) or additional skill building in their home.…”