- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03513510
Development and Pilot Testing of a Childhood Obesity Treatment Program
December 15, 2023 updated by: Virginia Polytechnic Institute and State University
Participatory Development and Pilot Testing of iChoose: An Adaptation of an Evidence-Based Pediatric Weight Management Program for Community Implementation
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.
Study Overview
Detailed Description
The Dan River Region (DRR) is a federally designated medically under-served area/population with high rates of obesity.
In response to 3 comprehensive community needs assessments The Dan River Partnership for a Healthy Community (DRPHC) was established in 2010 'to foster community partnership to combat obesity in the Dan River Region through healthy lifestyle initiatives' (DRPHC mission statement).
To date the DRPHC (1) tested a successful adult weight control intervention, (2) initiated youth-focus community garden and instant recess initiatives, and (3) continues to complete a comprehensive audit of the food and physical activity environment across the DRR.
This RFA provided an opportunity to address an additional and complimentary area of need for the DRPHC-childhood obesity.
A newly formed subcommittee and community advisory board (CAB) of the DRPHC, Partnering for Obesity Planning and Sustainability (POPS), met in preparation of this proposal and discussed the need to engage systems where high need families received services and could participate in childhood obesity treatment.
The POPS-CAB came to consensus that using a systems-based approach, within the existing CBPR partnership would allow for the development of a contextually relevant intervention with the potential for long-term sustainability.
Systems-based approaches include, but also move beyond, a focus on initiative effectiveness and address broader contextual issues such as initiative adoption, implementation, and maintenance across settings and delivery staff as well as reach and maintenance of effects at the individual level.
The general goal of this proposal is to engage multiple systems through the DRPHC POPS-CAB and design and test prototype childhood obesity interventions.
The current membership of the POPS-CAB include Danville Pittsylvania Health District, Children's Healthcare Center, Danville Parks Recreation & Tourism, and Boys & Girls Club, along with an interdisciplinary team of academic investigators.
The first aim is to assess community capacity to develop, implement, and sustain a childhood obesity reduction initiative in the DRR.
To accomplish this aim a concurrent mixed-method study design will be used and guided dimensions of community capacity and organizational level dimensions of the RE-AIM framework (i.e., adoption, implementation, and maintenance).
The second aim is to determine the potential reach, effectiveness, feasibility and cost of the newly developed interventions.
Three stages of iterative intervention testing/formative feedback loops in a public health and healthcare system will be used to achieve this aim.
The partnership members will meet in an ongoing basis to discuss the qualitative & quantitative results and make adaptations to improve the strategies.
Indicators of success include reduced child BMI z-scores, the engagement of multiple systems, and regional capacity to evaluate research evidence and integrate this evidence into sustainable practices.
The end goal is a childhood obesity intervention that is ready for large scale testing across these systems in the DRR.
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iChoose
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Community capacity to identify, adapt, and implement a childhood obesity program.
Time Frame: 2 years
|
qualitative interviews
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
child BMI z-score
Time Frame: 6-months
|
This is a age and gender normed standardization of child weight status.
|
6-months
|
reach
Time Frame: 6-months
|
the proportion of eligible families that enroll in the trial and their representativeness to the larger population of eligible families.
|
6-months
|
cost
Time Frame: 6 months
|
cost of intervention delivery.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul A Estabrooks, PhD, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
June 27, 2015
Study Completion (Actual)
November 30, 2016
Study Registration Dates
First Submitted
April 19, 2018
First Submitted That Met QC Criteria
April 19, 2018
First Posted (Actual)
May 1, 2018
Study Record Updates
Last Update Posted (Estimated)
December 21, 2023
Last Update Submitted That Met QC Criteria
December 15, 2023
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VT IRB 12-977
- R24MD008005 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There is no current plan.
Though we will comply with requests consistent with NIH data sharing policies.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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