Skip to main content
Clinical Trials/NCT01796067
NCT01796067
Completed
Not Applicable

Families Improving Together (FIT) for Weight Loss

University of South Carolina1 site in 1 country241 target enrollmentJuly 2012
ConditionsOverweightObese

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
University of South Carolina
Enrollment
241
Locations
1
Primary Endpoint
Change in Body Mass Index (z-BMI) in Adolescents
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
March 8, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dawn Wilson

Professor

University of South Carolina

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials