Families Improving Together (FIT) for Weight Loss

• ClinicalTrials.gov Identifier: NCT01796067
• Recruitment Status: Completed
• First Posted: February 21, 2013
• Last Update Posted: April 22, 2019
• Sponsor: University of South Carolina
• Collaborators: University of Michigan; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Dawn Wilson, University of South Carolina

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.

Condition or disease	Intervention/treatment	Phase
Overweight; Obese	Behavioral: Motivational and Family Weight Loss; Behavioral: Basic Health Education; Behavioral: Online Intervention; Behavioral: Online Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 241 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Families Improving Together (FIT) for Weight Loss
• Study Start Date: July 2012
• Actual Primary Completion Date: March 8, 2019
• Actual Study Completion Date: March 8, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mot. & Fam. Weight Loss + Online Interv.; 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: Mot. & Fam. Weight Loss + 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 Educ. & Online Interv.; 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 Educ. & 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Body Mass Index (z-BMI) in Adolescents [ Time Frame: Baseline to 2 months ]
   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.
2. Change in Body Mass Index (z-BMI) in Adolescents [ Time Frame: Baseline to 4 months ]
   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.
3. Change in Body Mass Index (z-BMI) in Adolescents [ Time Frame: Baseline to 6-month follow-up ]
   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 :

1. Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents [ Time Frame: Baseline to 4 months ]
   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.
2. Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents [ Time Frame: Baseline to 4 months ]
   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.
3. Change in Psychosocial Variables in Adolescents [ Time Frame: Baseline to 4 months ]
   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.
4. Change in Moderate to Vigorous Physical Activity in Adolescents [ Time Frame: Baseline to 6-month Follow-up ]
   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.
5. Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents [ Time Frame: Baseline to 6-month Follow-up ]
   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.
6. Change in Body Mass Index (z-BMI) in Parents [ Time Frame: Baseline to 4 months ]
   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.
7. Change in Body Mass Index (z-BMI) for Parents [ Time Frame: Baseline to 6 Months Follow-up ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 11 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, South Carolina

Obesity Research Group

Columbia, South Carolina, United States, 29201

Sponsors and Collaborators

University of South Carolina

University of Michigan

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Dawn K Wilson, PhD; University of South Carolina

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

• Responsible Party: Dawn Wilson, Professor, University of South Carolina
• ClinicalTrials.gov Identifier: NCT01796067
• Other Study ID Numbers: Pro00016136; R01HD072153 ( U.S. NIH Grant/Contract )
• First Posted: February 21, 2013
• Last Update Posted: April 22, 2019
• Last Verified: April 2019

Keywords provided by Dawn Wilson, University of South Carolina:

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

Additional relevant MeSH terms:

Overweight; Weight Loss; Body Weight; Body Weight Changes