CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 241 enrolled
Drug / intervention
Motivational and Family Weight Loss +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01796067
NCT01796067N/ACompleted

Families Improving Together (FIT) for Weight Loss

University of South Carolina·interventional·Posted Feb 21, 2013·Updated Apr 22, 2019

In Brief

A clinical study evaluating Motivational and Family Weight Loss, Basic Health Education, and 2 other interventions for Overweight and Obese. Completed, enrolled 241 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obese
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2013
Enrollment StartJul 1, 2012
Primary CompletionMar 8, 2019
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 13.4 years ago

Interventions

Motivational and Family Weight Lossbehavioral

This group will receive the comprehensive motivational and family weight loss intervention.

Basic Health Educationbehavioral

This group will receive the comprehensive basic health education intervention.

Online Interventionbehavioral

Participants will receive the online tailored weight loss intervention program after they have either received the motivational plus family weight loss program or basic health face-to-face program.

Online Controlbehavioral

Participants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program.