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Families Improving Together (FIT) for Weight Loss

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational and Family Weight Loss
Basic Health Education
Online Intervention
Online Control
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Motivational intervention, Positive Parenting Intervention, Obesity, Physical Activity, Diet, African American, Adolescent

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Obesity Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Mot. & Fam. Weight Loss + Online Interv.

Mot. & Fam. Weight Loss + Online Control

Basic Health Educ. & Online Interv.

Basic Health Educ. & Online Control

Arm Description

Participants are randomized to motivational and family weight loss program plus the online intervention.

Participants are randomized to motivational and family weight loss intervention and then the online control program.

Participants are randomized to the basic health education program and then the online intervention program.

Participants are randomized to the basic health education program and then to the online control program.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 22, 2013
Last Updated
April 18, 2019
Sponsor
University of South Carolina
Collaborators
University of Michigan, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01796067
Brief Title
Families Improving Together (FIT) for Weight Loss
Official Title
Families Improving Together (FIT) for Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
University of Michigan, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
Motivational intervention, Positive Parenting Intervention, Obesity, Physical Activity, Diet, African American, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mot. & Fam. Weight Loss + Online Interv.
Arm Type
Experimental
Arm Description
Participants are randomized to motivational and family weight loss program plus the online intervention.
Arm Title
Mot. & Fam. Weight Loss + Online Control
Arm Type
Experimental
Arm Description
Participants are randomized to motivational and family weight loss intervention and then the online control program.
Arm Title
Basic Health Educ. & Online Interv.
Arm Type
Experimental
Arm Description
Participants are randomized to the basic health education program and then the online intervention program.
Arm Title
Basic Health Educ. & Online Control
Arm Type
Active Comparator
Arm Description
Participants are randomized to the basic health education program and then to the online control program.
Intervention Type
Behavioral
Intervention Name(s)
Motivational and Family Weight Loss
Intervention Description
This group will receive the comprehensive motivational and family weight loss intervention.
Intervention Type
Behavioral
Intervention Name(s)
Basic Health Education
Intervention Description
This group will receive the comprehensive basic health education intervention.
Intervention Type
Behavioral
Intervention Name(s)
Online Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (z-BMI) in Adolescents
Description
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.
Time Frame
Baseline to 2 months
Title
Change in Body Mass Index (z-BMI) in Adolescents
Description
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.
Time Frame
Baseline to 4 months
Title
Change in Body Mass Index (z-BMI) in Adolescents
Description
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.
Time Frame
Baseline to 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Description
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.
Time Frame
Baseline to 4 months
Title
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents
Description
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.
Time Frame
Baseline to 4 months
Title
Change in Psychosocial Variables in Adolescents
Description
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.
Time Frame
Baseline to 4 months
Title
Change in Moderate to Vigorous Physical Activity in Adolescents
Description
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.
Time Frame
Baseline to 6-month Follow-up
Title
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents
Description
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.
Time Frame
Baseline to 6-month Follow-up
Title
Change in Body Mass Index (z-BMI) in Parents
Description
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.
Time Frame
Baseline to 4 months
Title
Change in Body Mass Index (z-BMI) for Parents
Description
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.
Time Frame
Baseline to 6 Months Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn K Wilson, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obesity Research Group
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33751355
Citation
Loncar H, Wilson DK, Sweeney AM, Quattlebaum M, Zarrett N. Associations of parenting factors and weight related outcomes in African American adolescents with overweight and obesity. J Behav Med. 2021 Aug;44(4):541-550. doi: 10.1007/s10865-021-00208-y. Epub 2021 Mar 9.
Results Reference
derived
PubMed Identifier
33738484
Citation
Kipp C, Wilson DK, Sweeney AM, Zarrett N, Van Horn ML. Effects of Parenting and Perceived Stress on BMI in African American Adolescents. J Pediatr Psychol. 2021 Aug 19;46(8):980-990. doi: 10.1093/jpepsy/jsab025.
Results Reference
derived
PubMed Identifier
32692356
Citation
Brown A, Wilson DK, Sweeney AM, Van Horn ML. The Moderating Effects of Social Support and Stress on Physical Activity in African American Women. Ann Behav Med. 2021 Apr 7;55(4):376-382. doi: 10.1093/abm/kaaa051.
Results Reference
derived
PubMed Identifier
31126345
Citation
Sweeney AM, Wilson DK, Loncar H, Brown A. Secondary benefits of the families improving together (FIT) for weight loss trial on cognitive and social factors in African American adolescents. Int J Behav Nutr Phys Act. 2019 May 24;16(1):47. doi: 10.1186/s12966-019-0806-5.
Results Reference
derived
PubMed Identifier
30892641
Citation
Wilson DK, Sweeney AM, Law LH, Kitzman-Ulrich H, Resnicow K. Web-Based Program Exposure and Retention in the Families Improving Together for Weight Loss Trial. Ann Behav Med. 2019 Mar 20;53(4):399-404. doi: 10.1093/abm/kay047.
Results Reference
derived
PubMed Identifier
25835731
Citation
Wilson DK, Kitzman-Ulrich H, Resnicow K, Van Horn ML, St George SM, Siceloff ER, Alia KA, McDaniel T, Heatley V, Huffman L, Coulon S, Prinz R. An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families. Contemp Clin Trials. 2015 May;42:145-57. doi: 10.1016/j.cct.2015.03.009. Epub 2015 Mar 30.
Results Reference
derived

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Families Improving Together (FIT) for Weight Loss

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