Clinical trial NCT01796067: Families Improving Together (FIT) for Weight Loss
Official title: Families Improving Together (FIT) for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: Motivational intervention
Positive Parenting Intervention
Obesity
Physical Activity
Diet
African American
Adolescent
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-02-21
Enrollment: 241
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Body Mass Index (z-BMI) in Adolescents
timeFrame: Baseline to 2 months
measure: Change in Body Mass Index (z-BMI) in Adolescents
timeFrame: Baseline to 4 months
measure: Change in Body Mass Index (z-BMI) in Adolescents
timeFrame: Baseline to 6-month follow-up
Secondary outcomes:
measure: Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
timeFrame: Baseline to 4 months
measure: Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents
timeFrame: Baseline to 4 months
measure: Change in Psychosocial Variables in Adolescents
timeFrame: Baseline to 4 months
measure: Change in Moderate to Vigorous Physical Activity in Adolescents
timeFrame: Baseline to 6-month Follow-up
measure: Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents
timeFrame: Baseline to 6-month Follow-up
measure: Change in Body Mass Index (z-BMI) in Parents
timeFrame: Baseline to 4 months
measure: Change in Body Mass Index (z-BMI) for Parents
timeFrame: Baseline to 6 Months Follow-up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Obesity Research Group
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Dawn K Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.