FRESH-DOSE: Families Responsibility Education Support Health-Dual Options for Sustained Effectiveness

University of California San Diego

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Family Based Behavioral Treatment; Behavioral: Guided Self-Help Fam. Based Bx Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03096132

R01DK108686 (U.S. NIH Grant/Contract)

160289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

Family Based Behavioral Treatment

Active Comparator group

Description:

The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a weekly group setting.

Treatment:

Behavioral: Family Based Behavioral Treatment

Guided Self-Help Fam. Based Bx Treatment

Experimental group

Description:

The program includes information about diet and physical activity education, in addition to parent management skills and behavior therapy strategies in a guided self-help manual.

Treatment:

Behavioral: Guided Self-Help Fam. Based Bx Treatment