Enhancing Emotion Regulation to Support Weight Control Efforts in Adolescents With Overweight and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 172
- 试验地点
- 6
- 主要终点
- Change in BMI from baseline to 12 months post-intervention
研究概览
简要总结
The prevalence of obesity in adolescents is remarkably high, with 38.7% of youth 12-15 years of age and 41.5% of 16-19 year olds meeting criteria for overweight or obesity. Behavioral weight control interventions for adolescents have had limited impact on this field and there is considerably more that needs to be done. Notably, adolescents who have difficulty managing their feelings have been found to consume higher caloric foods and report greater amounts of sedentary time. Poor emotion management among adolescents has also been associated with more rapid weight gain and higher BMI. Data from adolescents with overweight/obesity attending our outpatient weight management program (N=124) indicate that 82% of these youth report emotion regulation scores that are comparable to youth with significant mental health problems. Despite documented relationships between adolescent weight control and emotion regulation, no proven adolescent weight management programs targeting emotion regulation exist. To fill this gap, our laboratory developed and piloted an adolescent weight control intervention (HealthTRAC) that combines two previously tested effective interventions, one targeting emotion regulation skill building, the other focused on behavioral weight control. Findings from our small pilot trial are promising and indicate that the newly created HealthTRAC intervention is acceptable to parents and teens, easy to deliver, and leads to modest weight loss and improved emotion management skills compared to a standard behavioral weight control (SBWC) program. These data suggest that emotion regulation is related to weight management and may assist adolescents with overweight/obesity who are seeking to lose weight. The current multi-site study builds on this previous work and will examine the impact of the developed HealthTRAC intervention on improving emotion regulation skills and reducing adolescent BMI in a larger sample with longer term follow-up (18 months after starting the intervention). Adolescents will receive 27.5 hours of intervention time over a 12- month period. We expect that adolescents enrolled in the HealthTRAC intervention will show greater reduction in BMI over the 12-month program and will sustain these losses up to 18 months after starting the intervention compared to teens enrolled in SBWC. The information learned from this project will help us better understand how helping adolescents manage their emotions can improve weight loss outcomes.
详细描述
Participants will be assigned to one of two treatment conditions (HealthTRAC or Standard Behavioral Weight Control) using urn randomization procedure. Participants assigned to either condition will receive a 12-month weight control intervention that includes 12 weekly sessions and 2 bi-weekly sessions (14 primary sessions delivered over 4-months), followed by 8 months of maintenance sessions. Both conditions will also include parents at sessions 1, 7, and 14, and maintenance sessions at 6-8-,10-, and 12 months.
Both interventions will be delivered using a group-based treatment model. We selected a control condition that offers a more rigorous test of the program than a treatment as usual condition, commonly included in efficacy trials. Few studies have examined the combined impact of targeting emotion regulation skills and standard behavioral weight control strategies. Given the literature documenting the relationship between emotion regulation and weight-related behaviors, and the evidence from adult weight management studies, targeting this construct in adolescent populations may facilitate improved weight management outcomes via a reduction in emotional eating and sedentary time and improvement in overall diet quality.
The timing of study assessments immediately following intervention and at 12 months are justified by improvements in primary weight status outcomes observed in the treatment development study that was the immediate precursor of the proposed trial. Our previous work delivering adolescents weight control interventions supports our ability to retain participants through this study period. We have included an 18-month follow-up to examine sustainability of intervention effects. Few weight control interventions with adolescents include outcomes out to 18 months, and those that do, often have low rates of retention. Following established protocols, we anticipate approximately 80% retention at 18-month follow-up.
Participants will be enrolled into the efficacy trial continuously between Year 1, Month 6 and Year 4, Month 37. Consistent with the HealthTRAC pilot trial, we will recruit participants from primary care clinics and subspecialty clinics affiliated with children's hospitals, as well as through community advertisements. The majority of adolescent referrals to the treatment development study came from pediatric health care clinics at Hasbro Children's Hospital in Providence, RI (90%), with local advertisements accounting for the remainder. We anticipate that health care clinics will serve as a primary source for recruitment for the current trial. We will use parallel procedures to enroll participants in Providence, RI and Portland, OR. The PIs will work with representative staff from Hasbro Children's Hospital (RI) and Doernbecher Children's Hospital (OR) to distribute Consent to Contact forms, which can be completed by interested families. Families recruited in these settings will receive follow-up calls, emails, or texts (based on preference) to further determine initial eligibility and schedule consent/assents. Study brochures and advertisements will also be sent to adolescents who receive care within these various settings via direct home mailings. In addition to these successful approaches from the HealthTRAC pilot trial, we will also advertise through Facebook ads directed at parents. This strategy has been very effective in recent enrollment of adolescents to a behavioral weight control trial.
Initial evaluations will be conducted at the Weight Control and Diabetes Research Center or the University of Oregon Portland campus. Parents will undergo a brief interview and parents and adolescents will complete questionnaire measures. Adolescents will also complete computerized emotion regulation tasks. Parent questionnaires will focus on socio-demographic variables, the teen's dieting and medical history, any psychiatric history and treatment and emotion regulation abilities. Adolescent questionnaires will focus on emotion regulation abilities, mental health symptoms, and emotional eating. The first of the 24-hour dietary recalls will also be conducted during this visit, and adolescents will be provided instruction regarding completing 7-day accelerometry. Adolescent height and weight will be obtained at the end of the evaluation. Participants will be asked to return accelerometers after one week of wear or at the first intervention session, depending on the timing. Adolescents and parents will be informed of randomization condition at the first intervention session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in BMI from baseline to 12 months post-intervention
时间窗: baseline and 12 months after randomization
Weight (kilograms) and height (meters\^2) will be used to calculate body mass index (BMI; kg/m\^2)
次要结局
- Examine the impact of HealthTRAC relative to SBWC on dietary intake(baseline and 4-, 12-, 18- months after randomization)
- Examine the impact of HealthTRAC relative to SBWC on screen time(baseline and 4-, 12-, 18- months after randomization)
- Examine the impact of HealthTRAC relative to SBWC on emotion regulation(baseline and 4-, 12-, 18- months after randomization)
- Examine the impact of HealthTRAC relative to SBWC on emotional eating(baseline and 4-, 12-, 18- months after randomization)
- Examine the impact of HealthTRAC relative to SBWC on physical activity and sedentary behavior(baseline and 4-, 12-, 18- months after randomization)
