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

NCT03096132 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2023-05-15

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Family Based Behavioral Treatment

Treatment includes 20 90 minute visits over 6 months which include 60 min parent and child separate groups and 30 min behavioral coaching. FBT includes information regarding nutrition and physical activity, as well as behavior therapy skills, including parenting skills, self-monitoring, problem solving skills, motivation systems, emotional regulation, stress management, stimulus control, and relapse prevention.

BEHAVIORAL

Guided Self-Help Fam. Based Bx Treatment

Treatment includes 14 20 minute visits over 6 months. gshFBT is delivered to parent/child dyads and includes the same content in the FBT groups but it is provided in a manual. The 20-minute visits focus on clarifying information in the manuals, collecting weight and self-monitoring logs, and problem solving any barriers to implementation.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Kerri Boutelle, PhD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2023-01-05
Completion
2023-02-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096132 on ClinicalTrials.gov