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

NCT03096132 | Completed DMC

• 2 other identifiers: 160289R01DK108686
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Obesity; Overweight; Overeating; Body Mass Index; Treatment; Intervention; Family Based Therapy; Weight; Children

Outcome Measures

Primary Outcomes (2)

• Child weight loss

  BMI; BMIz

  Change from baseline to month 6, 12 and 18

• Cost-effectiveness

  Cost per .1 BMIz change in child weight including health care costs, participant costs and treatment costs.

  Baseline to month 6, 12 and 18

Secondary Outcomes (5)

• Parent BMI

  Change from baseline to month 6, 12 and 18

• Child Physical Activity - minutes of moderate-vigorous activity

  Change from baseline to month 6, 12 and 18

• Parent Physical Activity - minutes of moderate-vigorous activity

  Change from baseline to month 6, 12 and 18

• Child Nutrition-measured as servings of fruit and vegetables per day

  Change from baseline to month 6, 12 and 18

• Parent Nutrition-measured as servings of fruit and vegetables per day

  Change from baseline to month 6, 12 and 18

Study Arms (2)

Family Based Behavioral Treatment

ACTIVE COMPARATOR

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.

Behavioral: Family Based Behavioral Treatment

Guided Self-Help Fam. Based Bx Treatment

EXPERIMENTAL

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.

Behavioral: Guided Self-Help Fam. Based Bx Treatment

Interventions

Family Based Behavioral Treatment BEHAVIORAL

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.

Also known as: FBT

Family Based Behavioral Treatment

Guided Self-Help Fam. Based Bx Treatment BEHAVIORAL

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.

Also known as: gshFBT

Guided Self-Help Fam. Based Bx Treatment

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UCSD Center for Healthy Eating and Activity Research (CHEAR)

La Jolla, California, 92093, United States

Location

Related Publications (2)

• 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.

  PMID: 25181608 BACKGROUND

• 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.

  PMID: 23545372 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Hyperphagia; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Kerri Boutelle, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 30, 2017
• Study Start: April 18, 2017
• Primary Completion: January 5, 2023
• Study Completion: February 3, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

US (1)