Families Improving Together (FIT) for Weight Loss

NCT01796067 | Completed DMC

• 2 other identifiers: Pro00016136R01HD072153
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese

Keywords

Motivational intervention; Positive Parenting Intervention; Obesity; Physical Activity; Diet; African American; Adolescent

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents

  Baseline to 4 months

• Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents

  Baseline to 4 months

• Change in Psychosocial Variables in Adolescents

  Baseline to 4 months

• Change in Moderate to Vigorous Physical Activity in Adolescents

  Baseline to 6-month Follow-up

• Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents

  Baseline to 6-month Follow-up

Study Arms (4)

Mot. & Fam. Weight Loss + Online Interv.

EXPERIMENTAL

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

Behavioral: Motivational and Family Weight Loss; Behavioral: Online Intervention

Mot. & Fam. Weight Loss + Online Control

EXPERIMENTAL

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

Behavioral: Motivational and Family Weight Loss; Behavioral: Online Control

Basic Health Educ. & Online Interv.

EXPERIMENTAL

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

Behavioral: Basic Health Education; Behavioral: Online Intervention

Basic Health Educ. & Online Control

ACTIVE COMPARATOR

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

Behavioral: Basic Health Education; Behavioral: Online Control

Interventions

Motivational and Family Weight Loss BEHAVIORAL

This group will receive the comprehensive motivational and family weight loss intervention.

Mot. & Fam. Weight Loss + Online Control; Mot. & Fam. Weight Loss + Online Interv.

Basic Health Education BEHAVIORAL

This group will receive the comprehensive basic health education intervention.

Basic Health Educ. & Online Control; Basic Health Educ. & Online Interv.

Online Intervention BEHAVIORAL

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.

Basic Health Educ. & Online Interv.; Mot. & Fam. Weight Loss + Online Interv.

Online Control BEHAVIORAL

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.

Basic Health Educ. & Online Control; Mot. & Fam. Weight Loss + Online Control

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Adolescents with chronic illness
• Adolescents who require a specialized diet may not be eligible
• Developmental delay
• Partaking currently in another weight loss program

Sponsors & Collaborators

• University of South Carolina: lead
• University of Michigan: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Obesity Research Group

Columbia, South Carolina, 29201, United States

Location

Related Publications (10)

• Quattlebaum M, Sweeney AM, Wilson DK. Ecological predictors of family mealtime over time among overweight African American adolescent-parent dyads. J Behav Med. 2025 Aug;48(4):630-643. doi: 10.1007/s10865-025-00571-0. Epub 2025 May 15.

  PMID: 40374860 DERIVED

• Kipp C, Wilson DK, Brown A, Quattlebaum M, Loncar H, Sweeney AM, Abshire DA. Compounding effects of stress on diet, physical activity, and wellbeing among African American parents: a qualitative study to inform the LEADS health promotion trial. J Behav Med. 2024 Aug;47(4):647-661. doi: 10.1007/s10865-024-00477-3. Epub 2024 Mar 9.

  PMID: 38460063 DERIVED

• Sweeney AM, Wilson DK, Resnicow K, Van Horn ML, Kitzman H. Engagement With Tailored Physical Activity Content: Secondary Findings From the Families Improving Together for Weight Loss Randomized Controlled Trial. J Med Internet Res. 2023 Apr 12;25:e42581. doi: 10.2196/42581.

  PMID: 37043271 DERIVED

• Brown A, Wilson DK, Sweeney AM, van Horn ML, Zarrett N, Pate RR. Buffering effects of protective factors on light and moderate-to-vigorous physical activity among african american women. J Behav Med. 2023 Jun;46(3):405-416. doi: 10.1007/s10865-022-00360-z. Epub 2022 Oct 19.

  PMID: 36260160 DERIVED

• 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.

  PMID: 33751355 DERIVED

• 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.

  PMID: 33738484 DERIVED

• 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.

  PMID: 32692356 DERIVED

• 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.

  PMID: 31126345 DERIVED

• 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.

  PMID: 30892641 DERIVED

• 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.

  PMID: 25835731 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Dawn K Wilson, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: February 21, 2013
• Study Start: July 1, 2012
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

US (1)