Clinical trial NCT03096132: FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness
Official title: Effect of Treatment Dose on Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Obesity
Overweight
Overeating
Body Mass Index
Treatment
Intervention
Family Based Therapy
Weight
Children
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
First posted: 2017-03-30
Enrollment: 151
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate whether a less intensive intervention, Guided Self-Help Family Based Treatment (gshFBT), is non-inferior to the more intensive Family Based Treatment (FBT) for childhood obesity on child weight loss over 18-months. Cost-effectiveness of both treatments will also be compared.

Detailed description: The primary aim of this project is to determine whether gshFBT is non-inferior to FBT for childhood obesity on child weight loss. Four assessments will be conducted; baseline (month 0), month 6 (post-treatment), and at month 12 and month 18. Assessments will include the following for child and parent: anthropometry, physical activity, nutrition, and cost-effectiveness. Cost-effectiveness will be calculated from a societal perspective and a third party payor perspective. This program of research has the potential to advance the standard of practice for children who are overweight or obese by providing a less intensive but more cost-effective intervention.

Eligibility criteria: 1. An overweight child age 7-12, whose BMI is ≥ 85th percentile but does not meet criteria for severe obesity (i.e., BMI ≥120% of the 95th percentile or an absolute BMI ≥ 35 kg/m2 , whichever is lower for age and gender)
2. The parent willing to participate can read English at a minimum of a 5th grade level
3. Parent and Child willing to commit to attending all treatment and assessment sessions and be randomized to either treatment arm
4. Child or parent is free from psychiatric illness than may affect participation;
5. Child does not have any medical conditions that impact weight or may affect participation in physical activity or treatment
6. Child is not taking medications that may impact their weight (unless medication dosage is stable and not for the purpose of impacting weight and appetite)

Primary outcomes:
measure: Child weight loss
timeFrame: Change from baseline to month 6, 12 and 18
measure: Cost-effectiveness
timeFrame: Baseline to month 6, 12 and 18
Secondary outcomes:
measure: Parent BMI
timeFrame: Change from baseline to month 6, 12 and 18
measure: Child Physical Activity - minutes of moderate-vigorous activity
timeFrame: Change from baseline to month 6, 12 and 18
measure: Parent Physical Activity - minutes of moderate-vigorous activity
timeFrame: Change from baseline to month 6, 12 and 18
measure: Child Nutrition-measured as servings of fruit and vegetables per day
timeFrame: Change from baseline to month 6, 12 and 18
measure: Parent Nutrition-measured as servings of fruit and vegetables per day
timeFrame: Change from baseline to month 6, 12 and 18
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: UCSD
name: Kerri Boutelle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Accurso EC, Norman GJ, Crow SJ, Rock CL, Boutelle KN. The role of motivation in family-based guided self-help treatment for pediatric obesity. Child Obes. 2014 Oct;10(5):392-9. doi: 10.1089/chi.2014.0023. Epub 2014 Sep 2.
citation: Boutelle KN, Norman GJ, Rock CL, Rhee KE, Crow SJ. Guided self-help for the treatment of pediatric obesity. Pediatrics. 2013 May;131(5):e1435-42. doi: 10.1542/peds.2012-2204. Epub 2013 Apr 1.