Childhood ObesityNCT03513510
Development and Pilot Testing of a Childhood Obesity Treatment Program
A study testing iChoose in people with Childhood Obesity, run by Virginia Polytechnic Institute and State University.
Trial 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.… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- iChoose
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- iChoose
- Keywords
- evidence-based programs, community-based participatory research, program adoption
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iChooseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: iChoose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community capacity to identify, adapt, and implement a childhood obesity program.
qualitative interviews
Measured: 2 years
Secondary outcomes (3)
child BMI z-score
This is a age and gender normed standardization of child weight status.
Measured: 6-months
reach
the proportion of eligible families that enroll in the trial and their representativeness to the larger population of eligible families.
Measured: 6-months
cost
cost of intervention delivery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Jan 2013
- Primary completion27 Jun 2015
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Pittsylvania/Danville Health District, National Institute on Minority Health and Health Disparities (NIMHD), Children's Healthcare Center, Boys and Girls Club of Danville, Danville Parks and Recreation
- Responsible party
- Sponsor
- Investigators
- Paul A Estabrooks, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513510
- Sponsor's protocol ID
- VT IRB 12-977
- Other IDs
- R24MD008005
- Status last verified
- Feb 2019
- First submitted
- 19 Apr 2018
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan. Though we will comply with requests consistent with NIH data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Participatory Development and Pilot Testing of iChoose: An Adaptation of an Evidence-Based Pediatric Weight Management Program for Community Implementation
- ClinicalTrials.gov ID
- NCT03513510
- Acronym / sponsor ID
- VT IRB 12-977
- Conditions
- Childhood Obesity
- Keywords
- evidence-based programs, community-based participatory research, program adoption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Pittsylvania/Danville Health District, National Institute on Minority Health and Health Disparities (NIMHD), Children's Healthcare Center, Boys and Girls Club of Danville, Danville Parks and Recreation
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 27 Jun 2015 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iChoose | Experimental | Behavioral: iChoose6 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 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- children with a major cognitive impairment and parents or children with a medical contraindication for moderate physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iChoose | Behavioural | iChoose |
Primary outcome
Community capacity to identify, adapt, and implement a childhood obesity program.
Time frame: 2 years
qualitative interviews
3 secondary outcomes
child BMI z-score
Time frame: 6-months
reach
Time frame: 6-months
cost
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No. There is no current plan. Though we will comply with requests consistent with NIH data sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Estabrooks, PhD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing iChoose in people with Childhood Obesity, run by Virginia Polytechnic Institute and State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community capacity to identify, adapt, and implement a childhood obesity program. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.