跳至主要内容
临床试验/NCT07839832
NCT07839832招募中不适用

Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

Stanford University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Change in body mass index from baseline to 12 months

研究概览

简要总结

Past modest, transient and highly variable outcomes from many behavioral treatments for pediatric obesity may be, in part, because of the psychological barriers children with obesity face when trying to control their weight. The goal of this randomized controlled trial is to test whether adding two innovative, brief, social psychological activities (termed "wise" interventions) to a high quality, family-based, group behavioral weight control program, will produce better outcomes among participating children with obesity.

The primary hypothesis is that children who receive the family-based, group, behavioral weight control program plus the wise social psychological interventions will have significantly less body mass index growth over 12 months than children who receive the family-based, group, behavioral weight control program plus additional educational content.

Participants will be asked to do participate in the six month treatment program and complete measurements at the beginning of the study, after 3 months, after 6 months (the end of the behavioral treatment program), and after 12 months (6 months after completing the behavioral treatment program).

This study has the potential to substantially improve the outcomes of pediatric weight control treatments and significantly reduce concurrent and future health, psychological and social harms from childhood obesity.

详细描述

We propose a 2-arm, parallel group, randomized controlled trial to test the efficacy of adding two innovative "wise" social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care family-based, group behavioral intervention for weight control in children with obesity, to reduce body mass index trajectory over 12 months, compared to the usual care behavioral intervention alone.

A total of 200 10-15-year-old children with obesity (BMI ≥ 95th percentile) will participate. All children will participate with their parents in a usual care six-month, family-based, group, behavioral weight control program. In addition, families randomized to the wise intervention condition will receive two, innovative social psychological interventions-growth mindset and self-affirmation-strategically selected and timed to enhance the behavioral intervention.

There remains a great need for innovative approaches to increase and sustain weight loss among children with obesity. We propose that existing weight control interventions are limited in their success with many children in part because of the many psychological barriers and threats they face when attempting to manage their weight. One novel and potentially effective and efficient way to enhance the success of behavioral treatments may be to focus on changing the mindsets and preparedness of the participant.

Measures will be collected at baseline, 3 months, 6 months (end of the behavioral treatment), and 12 months (follow-up 6 months after the end of treatment) from children and parents. Body mass index (BMI) trajectory over the entire 12 months is the primary outcome measure. Secondary outcome measures and potential moderating and/or mediating variables include waist circumference and triceps skinfold thickness, parent weight outcomes, physical activity (accelerometery), energy intake (24-hour dietary recalls), screen time, and hypothesized mediators of the behavioral intervention and the two social psychological interventions. We propose highly rigorous and transparent RCT methods.

Primary Hypothesis: Compared to children randomized to receive the usual care family-based, group behavioral weight control program alone, children randomized to receive the usual care family-based, group behavioral weight control program plus the wise social psychological interventions will have a significantly attenuated BMI trajectory over 12 months.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •- 10-15 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. - Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate

排除标准

  • •Medical conditions affecting growth
  • •Medications affecting growth
  • •Conditions limiting participation in the interventions
  • •Conditions limiting participation in the assessments
  • •Unable to read, understand or complete informed consent in English or Spanish

研究组 & 干预措施

Wise interventions plus behavioral Rx

Experimental

Wise social psychological interventions (growth mindset and values self-affirmation) plus a usual care family-based, group, behavioral intervention for weight control.

干预措施: Wise interventions -- values self-affirmation and growth mindset -- plus usual care behavioral treatment (Behavioral)

Education plus behavioral Rx

Active Comparator

Health education plus a family-based, group, usual care behavioral intervention for weight control

干预措施: Education plus usual care behavioral treatment (Behavioral)

结局指标

主要结局

Change in body mass index from baseline to 12 months

时间窗: Change from baseline to 12 months

body mass index = weight in kilograms divided by the squared height in meters

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Robinson

Professor

Stanford University

研究点 (1)

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