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Families Improving Together (FIT) for Weight Loss

University of South Carolina logo

University of South Carolina

Status

Completed

Conditions

Obese
Overweight

Treatments

Behavioral: Online Control
Behavioral: Online Intervention
Behavioral: Motivational and Family Weight Loss
Behavioral: Basic Health Education

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01796067
Pro00016136
R01HD072153 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

241 patients

Sex

All

Ages

11 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

241 participants in 4 patient groups

Mot. & Fam. Weight Loss + Online Interv.
Experimental group
Description:
Participants are randomized to motivational and family weight loss program plus the online intervention.
Treatment:
Behavioral: Motivational and Family Weight Loss
Behavioral: Online Intervention
Mot. & Fam. Weight Loss + Online Control
Experimental group
Description:
Participants are randomized to motivational and family weight loss intervention and then the online control program.
Treatment:
Behavioral: Motivational and Family Weight Loss
Behavioral: Online Control
Basic Health Educ. & Online Interv.
Experimental group
Description:
Participants are randomized to the basic health education program and then the online intervention program.
Treatment:
Behavioral: Online Intervention
Behavioral: Basic Health Education
Basic Health Educ. & Online Control
Active Comparator group
Description:
Participants are randomized to the basic health education program and then to the online control program.
Treatment:
Behavioral: Online Control
Behavioral: Basic Health Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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