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临床试验/NCT01796067
NCT01796067已完成不适用

Families Improving Together (FIT) for Weight Loss

University of South Carolina2 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
2
主要终点
Change in Body Mass Index (z-BMI) in Adolescents

研究概览

简要总结

The increasing rate of obesity has become a major public health concern with national reports indicating 40% of African American adolescents are now overweight/obese. Little is known about effective weight loss interventions in ethnic minority adolescents. However, research has shown that ethnic minorities attend fewer intervention sessions, have higher attrition rates and lose less weight compared to Caucasians. Two fundamental problems related to this lack of progress are 1) lack of appropriate content of weight loss interventions for African American adolescents that integrate cultural issues, parenting skills, and motivational strategies for long-term change and, 2) poor dose of weight loss interventions because of participant fatigue and drop out. While previous weight loss studies for adolescents have been long lasting (12-25 weeks), our team developed a weight loss program that is a relatively brief (8-week) face-to-face intervention that integrates motivational (autonomy-support) and positive parenting skills (monitoring, social support, positive communication skills) for reducing z-BMI in overweight African American adolescents. Our team recently conducted a pilot study testing the feasibility of an 8-week on-line culturally tailored intervention, Thus, the goal of this project is to conduct a randomized controlled efficacy trial to address the problems with past studies by 1) making the face-to-face group intervention shorter, 2) using an on-line component to compliment the group-based intervention for increasing dose, and by 3) tailoring a motivational and parenting skills program directly to parents and adolescents skill levels and cultural background. 520 overweight African American adolescents and their parents will be recruited to participate. Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education program on reducing z-BMI and improving diet and physical activity (PA) in overweight African American adolescents. In phase II of the trial participants will be re-randomized to either an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention program will show the greatest maintenance in reducing z-BMI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Must have a parent or primary caregiver who lives in the same house as the adolescent
  • Live within 60 miles of the program's office
  • Have at least 3 grandparents who are African American
  • Access to the internet
  • Children between the ages of 11 and 16
  • Child must have BMI above 85th percentile and below 99th percentile
  • Have no medical condition that would limit participation in moderate intensity exercise including life-threatening illness (e.g., immobile, severely disabled, or bed ridden)
  • Available and able to participate in measures and intervention activities over the next year

排除标准

  • Adolescents with chronic illness
  • Adolescents who require a specialized diet may not be eligible
  • Developmental delay
  • Partaking currently in another weight loss program

研究组 & 干预措施

Basic Health Educ. & Online Interv.

Experimental

Participants are randomized to the basic health education program and then the online intervention program.

干预措施: Online Intervention (Behavioral)

Basic Health Educ. & Online Control

Active Comparator

Participants are randomized to the basic health education program and then to the online control program.

干预措施: Basic Health Education (Behavioral)

Basic Health Educ. & Online Control

Active Comparator

Participants are randomized to the basic health education program and then to the online control program.

干预措施: Online Control (Behavioral)

Mot. & Fam. Weight Loss + Online Interv.

Experimental

Participants are randomized to motivational and family weight loss program plus the online intervention.

干预措施: Motivational and Family Weight Loss (Behavioral)

Mot. & Fam. Weight Loss + Online Interv.

Experimental

Participants are randomized to motivational and family weight loss program plus the online intervention.

干预措施: Online Intervention (Behavioral)

Mot. & Fam. Weight Loss + Online Control

Experimental

Participants are randomized to motivational and family weight loss intervention and then the online control program.

干预措施: Motivational and Family Weight Loss (Behavioral)

Mot. & Fam. Weight Loss + Online Control

Experimental

Participants are randomized to motivational and family weight loss intervention and then the online control program.

干预措施: Online Control (Behavioral)

Basic Health Educ. & Online Interv.

Experimental

Participants are randomized to the basic health education program and then the online intervention program.

干预措施: Basic Health Education (Behavioral)

结局指标

主要结局

Change in Body Mass Index (z-BMI) in Adolescents

时间窗: Baseline to 6-month follow-up

We are investigating intervention effects on change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 6 months post-intervention. Specifically, we will examine whether there are group differences (i.e., M+FWL \& Intervention online, M+FWL \& Control online, BH \& Intervention online, BH \& Control online) in maintenance in BMI in adolescents.

次要结局

  • Change in Psychosocial Variables in Adolescents(Baseline to 4 months)
  • Change in Body Mass Index (z-BMI) for Parents(Baseline to 6 Months Follow-up)
  • Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents(Baseline to 4 months)
  • Change in Body Mass Index (z-BMI) in Parents(Baseline to 4 months)
  • Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents(Baseline to 4 months)
  • Change in Moderate to Vigorous Physical Activity in Adolescents(Baseline to 6-month Follow-up)
  • Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents(Baseline to 6-month Follow-up)

研究者

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

Dawn Wilson

Professor

University of South Carolina

研究点 (2)

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