Trials / Completed
CompletedNCT01796067
Families Improving Together (FIT) for Weight Loss
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 241 (actual)
- Sponsor
- University of South Carolina · Academic / Other
- Sex
- All
- Age
- 11 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Motivational and Family Weight Loss | This group will receive the comprehensive motivational and family weight loss intervention. |
| BEHAVIORAL | Basic Health Education | This group will receive the comprehensive basic health education intervention. |
| BEHAVIORAL | Online Intervention | 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. |
| BEHAVIORAL | Online Control | 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. |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2019-03-08
- Completion
- 2019-03-08
- First posted
- 2013-02-21
- Last updated
- 2019-04-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01796067. Inclusion in this directory is not an endorsement.