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NCT01796067 · ClinicalTrials.gov registry record · NA
Families Improving Together (FIT) for Weight Loss
A NA study of Overweight and Obese, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 241
- Enrollment target
- 1
- Study location
NCT01796067: Completed NA study of Overweight and Obese, sponsored by University of South Carolina.
NCT01796067 is a NA study of Overweight and Obese that has completed, run by University of South Carolina. The registered enrollment target is 241 participants, below the 1,322-participant average among 197 other Overweight trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01796067, a NA study of Overweight and Obese, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 241 participants
- Enrollment target
- 1
- Study location
Study 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-BM
Primary Outcome
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 2 months and whether there are group differences (i.e., M+FWL vs. BH groups) in change in BMI in adolescents.
Conditions Studied
Interventions
- BEHAVIORAL Motivational and Family Weight Loss
- BEHAVIORAL Basic Health Education
- BEHAVIORAL Online Intervention
- BEHAVIORAL Online Control
Study Locations (1)
South Carolina
- Obesity Research Group - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2012-07 |
| Est. Completion | 2019-03-08 |
| Phase | NA |
What the finished NCT01796067 record still lists
NCT01796067 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 1,322-participant average among 197 other Overweight trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Overweight appearing as the primary indexed condition, and to 4 interventions - of which Motivational and Family Weight Loss is the first listed.
NCT01796067 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT01796067 about?
NCT01796067 is a clinical study titled "Families Improving Together (FIT) for Weight Loss". 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 min...
What is the current status of trial NCT01796067?
This trial is currently completed. It is a NA study. The enrollment target is 241 participants. The study started on 2012-07. Estimated completion is 2019-03-08.
What conditions does trial NCT01796067 study?
This clinical trial studies the following conditions: Overweight, Obese.
What interventions are being tested in trial NCT01796067?
The interventions under investigation include: Motivational and Family Weight Loss (BEHAVIORAL), Basic Health Education (BEHAVIORAL), Online Intervention (BEHAVIORAL), Online Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT01796067?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01796067 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01796067's enrollment target sits among peer trials
241 67th of 197 higher than 131 of 197 other Overweight trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overweight trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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