A Trial of Two Family-based Childhood Obesity Treatment Programs

NCT03245775 | Completed Results DMC

• 1 other identifier: 19748
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to determine the relative effectiveness in child BMI z-scores at 3, 6, and 12-months post baseline of iChoose+ versus Family Connections. Secondary aims are to determine (1) ongoing reach, fidelity, and implementation costs, (2) community capacity for implementation and sustainability, (3) relative impact on family eating/physical activity and parental weight, and (4) relative adherence and potential dose response relationships.

Conditions

Obesity, Childhood

Keywords

health disparities; community-based participatory research

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Child Body Mass Index (BMI) Z-score at 6 Months

  child BMI is converted to a BMI Z score which uses a standardized distribution. A BMI z score of 0 indicates an average BMI for the childs height, weight, age, and gender. Positive z-scores indicate the number of standard deviations above the norm, while negative numbers indicate the number of standard deviations below the norm. Higher z scores indicate a greater BMI status for the child. The primary outcome is a change score, or the difference between the 6 month BMI z-score and the Baseline BMI z-score. A negative score will indicate BMI z score status reductions and is a positive finding.

  Baseline and 6-months

Secondary Outcomes (3)

• Change From Baseline of Parent Body Mass Index (BMI) at 6 Months

  Baseline and 6-months

• Change From Baseline in the Pediatric Quality of Life Inventory for Children Score at 6 Months

  Baseline and 6-months

• Change From Baseline in the Healthy Days Core Module for Parents at 6 Months

  Baseline and 6-months

Study Arms (2)

iChoose

EXPERIMENTAL

12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only

Behavioral: iChoose

Family Connections

EXPERIMENTAL

2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only

Behavioral: Family Connections

Interventions

iChoose BEHAVIORAL

12 bi-weekly sessions \& 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only

iChoose

Family Connections BEHAVIORAL

2 in-person sessions spaced one week apart \& 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only

Family Connections

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/child dyads will be eligible for participation if they reside in the Dan River Region
• English speaking
• child with a BMI percentile ranking of 85 or higher
• Cohort 3 age eligibility changed from 8-12 to 5-15

You may not qualify if:

• children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity.

Sponsors & Collaborators

• University of Virginia: lead
• University of Nebraska: collaborator
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908-0717, United States

Location

Related Publications (1)

• Zoellner JM, You W, Hill JL, Brock DP, Yuhas M, Alexander RC, Price B, Estabrooks PA. A comparative effectiveness trial of two family-based childhood obesity treatment programs in a medically underserved region: Rationale, design & methods. Contemp Clin Trials. 2019 Sep;84:105801. doi: 10.1016/j.cct.2019.06.015. Epub 2019 Jun 28.

  PMID: 31260792 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jamie Zoellner, Professor of Public Health Sciences
• Organization: University of Virginia

jz9q@virginia.edu

4349624488

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: June 1, 2017
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2020
• Last Updated: June 28, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)