Development and Pilot Testing of a Childhood Obesity Treatment Program

NCT03513510 | Completed

• 2 other identifiers: VT IRB 12-977R24MD008005
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aims were to assess community capacity to develop, implement, and sustain a childhood obesity reduction initiative in the health-disparate Dan River Region as well as to pilot test iChoose to determine the potential reach (i.e., proportion of target population \& representativeness), effectiveness (i.e., changes in child BMI z-scores over a 6 month period), feasibility (i.e., the degree to which the intervention can be adopted, implemented, and sustained as intended) and cost (i.e., resource and staffing costs) of the newly developed intervention.

Conditions

Childhood Obesity

Keywords

evidence-based programs; community-based participatory research; program adoption

Outcome Measures

Primary Outcomes (1)

• Community capacity to identify, adapt, and implement a childhood obesity program.

  qualitative interviews

  2 years

Secondary Outcomes (3)

• child BMI z-score

  6-months

• reach

  6-months

• cost

  6 months

Study Arms (1)

iChoose

EXPERIMENTAL

6 biweekly family sessions, 6 biweekly telephone support calls to parents, 6 biweekly newsletters for children, and 3 supervised exercise sessions per week/3 months; delivers intervention to parents and children only

Behavioral: iChoose

Interventions

iChoose BEHAVIORAL

iChoose

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/child dyads were eligible for participation if they resided in the Dan River Region
• English speaking
• child with a BMI percentile ranking of 85 or higher

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

• Virginia Polytechnic Institute and State University: lead
• Pittsylvania/Danville Health District: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Children's Healthcare Center: collaborator
• Boys and Girls Club of Danville: collaborator
• Danville Parks and Recreation: collaborator

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

Study Officials

• Paul A Estabrooks, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: January 1, 2013
• Primary Completion: June 27, 2015
• Study Completion: November 30, 2016
• Last Updated: December 21, 2023

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share