Trial record 11 of 354 for:    Open Studies | "weight loss"

Families Improving Together (FIT) for Weight Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of South Carolina
Sponsor:
Collaborators:
University of Michigan
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01796067
First received: January 22, 2013
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The increasing rate of obesity has become a major public health concern with national reports indicating 40% of African American adolescents are now overweight or obese. Little is known about effective weight loss interventions in ethnic minority adolescents. In part, this is because 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) the 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) the poor dose of weight loss interventions because of participant fatigue and drop out. Previous weight loss studies among adolescents have been of relatively long duration lasting 12-25 weeks, however, our team has 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 has also recently conducted a pilot study testing the feasibility of an 8-week on-line intervention that is culturally tailored for African American families. 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. This design will allow us to test the effects of the M+FWL curriculum and the added effects of the on-line intervention component on reducing z-BMI in African American adolescents and their parents. 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. Psychosocial mediators of treatment effects will be examined as well as treatment effects related to parent changes in z-BMI and health behaviors (diet and PA).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Families Improving Together (FIT) for Weight Loss

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Change in Body Mass Index (z-BMI) in Adolescents [ Time Frame: Baseline to 2 months ] [ Designated as safety issue: No ]
    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.

  • Change in Body Mass Index (z-BMI) in Adolescents [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.

  • Change in Body Mass Index (z-BMI) in Adolescents [ Time Frame: Baseline to 6-month follow-up ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.

  • Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.

  • Change in Psychosocial Variables in Adolescents [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.

  • Change in Moderate to Vigorous Physical Activity in Adolescents [ Time Frame: Baseline to 6-month Follow-up ] [ Designated as safety issue: No ]
    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.

  • Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents [ Time Frame: Baseline to 6-month Follow-up ] [ Designated as safety issue: No ]
    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.

  • Change in Body Mass Index (z-BMI) in Parents [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]
    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.

  • Change in Body Mass Index (z-BMI) for Parents [ Time Frame: Baseline to 6 Months Follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 520
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational and Family Weight Loss plus Online Intervention
Participants are randomized to motivational and family weight loss program plus the online intervention.
Behavioral: Motivational and Family Weight Loss
This group will receive the comprehensive motivational and family weight loss 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.
Experimental: Motivation and Family Weight Loss plus Online Control
Participants are randomized to motivational and family weight loss intervention and then the online control program.
Behavioral: Motivational and Family Weight Loss
This group will receive the comprehensive motivational and family weight loss intervention.
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.
Experimental: Basic Health Education and Online Intervention
Participants are randomized to the basic health education program and then the online intervention program.
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.
Active Comparator: Basic Health Education and Online Control
Participants are randomized to the basic health education program and then to the online control program.
Behavioral: Basic Health Education
This group will receive the comprehensive basic health education intervention.
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.

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796067

Contacts
Contact: Dawn K Wilson, PhD 803-450-0FIT wilsondk@mailbox.sc.edu

Locations
United States, South Carolina
Obesity Research Group Recruiting
Columbia, South Carolina, United States, 29201
Contact: Kaya Outen       outenk@mailbox.sc.edu   
Principal Investigator: Dawn K Wilson, PhD         
Sponsors and Collaborators
University of South Carolina
University of Michigan
Investigators
Principal Investigator: Dawn K Wilson, PhD University of South Carolina
  More Information

No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01796067     History of Changes
Other Study ID Numbers: Project FIT, R01HD072153
Study First Received: January 22, 2013
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Data and Safety Monitoring Board

Keywords provided by University of South Carolina:
Motivational intervention
Positive Parenting Intervention
Obesity
Physical Activity
Diet
African American
Adolescent

Additional relevant MeSH terms:
Weight Loss
Overweight
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014