Families Improving Together (FIT) for Weight Loss

Overweight Clinical Trial

Official title:

Families Improving Together (FIT) for Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796067
• Other study ID #: Pro00016136
• Secondary ID: R01HD072153
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: March 8, 2019

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Overweight
• Weight Loss

Intervention

Behavioral:
• Motivational and Family Weight Loss
This group will receive the comprehensive motivational and family weight loss intervention.
• Basic Health Education
This group will receive the comprehensive basic health education intervention.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Obesity Research Group	Columbia	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Mass Index (z-BMI) in Adolescents	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.	Baseline to 2 months
Primary	Change in Body Mass Index (z-BMI) in Adolescents	We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in adolescents.	Baseline to 4 months
Primary	Change in Body Mass Index (z-BMI) in Adolescents	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.	Baseline to 6-month follow-up
Secondary	Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents	Minutes per day; We are investigating whether there is change of physical activity from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in MVPA in parents and adolescents.	Baseline to 4 months
Secondary	Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents	We are investigating whether there is change of Kcals at 4 months. We are looking at these effects for fruit and vegetable intake, as well as total fat intake and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in diet in parents and adolescents.	Baseline to 4 months
Secondary	Change in Psychosocial Variables in Adolescents	Examine the effects of psychosocial variables (autonomy-support, monitoring, communication) as potential mediators of the intervention effects on changes in z-BMI, dietary intake, and MVPA in adolescents.	Baseline to 4 months
Secondary	Change in Moderate to Vigorous Physical Activity in Adolescents	Minutes per day; We are investigating whether there is change of physical activity at the 6-month follow-up and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in MVPA in adolescents.	Baseline to 6-month Follow-up
Secondary	Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents	We are investigating whether there is change of Kcals at 6-month follow-up. We are specifically looking at effects for fruit and vegetable intake, as well as total fat intake in adolescents, and vegetable intake, as well as total fat intake and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in diet in adolescents.	Baseline to 6-month Follow-up
Secondary	Change in Body Mass Index (z-BMI) in Parents	We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in parents.	Baseline to 4 months
Secondary	Change in Body Mass Index (z-BMI) for Parents	We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 6 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in parents.	Baseline to 6 Months Follow-up