- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04719442
Packaging Building Healthy Families for Community Implementation (NECORD)
Translating Efficacious Pediatric Weight Management Interventions Into Rural & Micropolitan Communities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Since the early 1980s, a number of efficacious pediatric weight management interventions (PWMI) have been developed to reduce child weight status. Epstein's Traffic Light Diet (TLD) is likely the most studied PWMI and has demonstrated efficacy across a wide range of randomized controlled trials in children up to and older than 12 years of age. This work and the majority of efficacious PWMI have been based in large urban areas delivered through a hospital or medical center and the most recent childhood obesity treatment recommendations do not address geographically underserved audiences or settings where all members of an interdisciplinary team may not exist. As a result, there is no information on the degree to which evidence-based PWMIs have been translated into micropolitan (cities<50,000) and rural settings. This is an important issue when considering the prevalence of obesity is higher, socioeconomic status and access to preventive healthcare is lower, and 20% of the nation's populations reside in rural areas based on the most recent census data. A related issue is the potential mismatch between the resources and expertise used to deliver research and hospital-based PWMIs in urban, when compared to micropolitan and rural, areas. Thus, adoption, implementation, and sustainability may be limited in micropolitan and surrounding rural areas unless adaptations are made that leverage multiple systems within the community that interact with families and children and strategies include a balanced focus on reach and effectiveness to increase the likelihood of having a public health impact. To address these issues the research team has implemented an adapted version of the TLD in Kearney, Nebraska, developed and used training approaches for PWMI for underserved micropolitan settings, and conducted a number of implementation trials focused on planning for, and evaluating, PWMI reach, effectiveness, adoption, implementation and maintenance (RE-AIM). This includes research examining models of participant identification and engagement within settings where a large proportion of children are screened for obesity-schools and primary care pediatric clinics. Building Healthy Families (BHF), the investigators' TLD adaptation, includes the required or more contact hours through regular and frequent in-person contact with families and leverages the expertise and time of health professionals from a variety of local organizations. BHF has been implemented locally and successfully achieved clinically and statistically significant reductions in child BMI z-score (-0.27±0.22). Through collaborative efforts the research team has developed online resources for organizations interested in delivering PWMIs, training modules for related interventions, and participant-facing program materials that could be combined into a 'turn-key' approach for communities interested in reducing childhood obesity. The investigators preliminary work demonstrates that the adapted TLD intervention can achieve a similar magnitude of effect relative to previous efficacy trials, that the associated training materials and approaches can result in a high level of implementation fidelity, and that ongoing program adaptations to address local needs can be made. To date, the research team has not combined all of these approaches and materials as a turn-key package that could be adopted, adapted, and sustained in other micropolitan/rural communities.
The first aim is to collaboratively refine and develop an intervention package for the TLD that includes all of the materials necessary for others to implement the intervention in new micropolitan and rural locations. The second aim is to perform a rigorous, mixed-methods pilot implementation research study using an innovative community application process to identify 4 to 8 new communities to pilot test the utility of the packaged PWMI and training materials when coupled with a learning collaborative facilitation strategy and sustainability action planning process in supporting PWMI adoption, implementation, and sustainability when compared to receiving access to the packaged program and training materials alone. Additional outcomes will include start-up and ongoing costs while tracking intervention reach, representativeness, and effectiveness in reducing and maintaining child weight status relative to a matched cohort. The third aim is to use the pilot evaluation data and results of the sustainability action plan to refine program and training materials and develop a dissemination plan to move the program to other communities.
To complete these aims the investigators will engage an existing partnerships that includes local schools and pediatricians in Kearney, NE and the Great Plains IDeA Clinical and Translational Research Network Community Advisory Board who has identified childhood obesity treatment, particularly in rural areas, across North Dakota, South Dakota, and Nebraska as a priority. As is recommended, the approach will use an implementation research explanatory process, and outcome model to test hypotheses related to implementation and sustainability, engaging community/clinical partners in the implementation and sustainability process, and evaluate outcomes at both the individual and organizational level. Specifically, the Promoting Action on Research Implementation in Health Services (PARIHS) Framework will be used as the explanatory model and the RE-AIM framework to track individual reach, representativeness, effectiveness and organizational cost, adoption, implementation, and sustainability.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child 6 to 12 years of age
- Child with BMI percentile at or above the 95th percentile
- parents and/or guardian of child who meets the inclusion criteria
Exclusion Criteria:
- Child with major cognitive or physical impairments
- Child or parents/guardians with a contraindication for physical activity
- Families participating in a concurrent pediatric weight management intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BHF-LC
To test an innovative implementation strategy, four communities will be assigned to pilot test the packaged PWMI and training materials when coupled with a learning collaborative facilitation strategy and sustainability action planning process to support PWMI adoption, implementation, and sustainability (BHF-LC).
|
Building Healthy Families (BHF) is a family based obesity treatment program which includes key behavior change strategies including goal setting for both behavior change and weight loss, self-monitoring, rewards/contingency management, role modeling, and stimulus control/ modifying the environment.
BHF includes a minimum of 32 contact hours consisting of three main program components: nutrition education, behavior modification, and physical activity.
Participants and parents are expected to attend 12 continuous weeks of education (2 hours/session) followed by 12 weeks of relapse prevention refresher courses.
Relapse prevention refresher sessions are every three weeks for one hour to re-evaluate goals, discuss rewards/contingency management and changes in stimulus control with seasonal changes and holidays.
A final follow-up check-in session is conducted at 12 months for approximately 1 hour.
Other Names:
|
Active Comparator: BHF-Program Only
Four other communities will be assigned to receive the packaged PWMI and training program only.
|
Building Healthy Families (BHF) is a family based obesity treatment program which includes key behavior change strategies including goal setting for both behavior change and weight loss, self-monitoring, rewards/contingency management, role modeling, and stimulus control/ modifying the environment.
BHF includes a minimum of 32 contact hours consisting of three main program components: nutrition education, behavior modification, and physical activity.
Participants and parents are expected to attend 12 continuous weeks of education (2 hours/session) followed by 12 weeks of relapse prevention refresher courses.
Relapse prevention refresher sessions are every three weeks for one hour to re-evaluate goals, discuss rewards/contingency management and changes in stimulus control with seasonal changes and holidays.
A final follow-up check-in session is conducted at 12 months for approximately 1 hour.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Program Implementation
Time Frame: up to 12 weeks
|
% of objectives met during intervention sessions
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Mass Index percentile ranking
Time Frame: Calculated four times, baseline, 3-months, 6-months and 12 months
|
Using standardized calculation for degree of childhood obesity as a function of height, weight, age and gender
|
Calculated four times, baseline, 3-months, 6-months and 12 months
|
Reach
Time Frame: measured once at enrollment
|
number of children enrolled
|
measured once at enrollment
|
Height in Meters
Time Frame: Measured once at baseline
|
Measured in adults using a standard stadiometer
|
Measured once at baseline
|
Weight in Kilograms
Time Frame: Measured 4 times; baseline, 3 months, 6-months and 12 months.
|
Measured in adults using a research grade scale
|
Measured 4 times; baseline, 3 months, 6-months and 12 months.
|
Body Mass Index
Time Frame: Calculated 4 times; baseline, 3-months, 6-months and 12 months
|
Calculated for adults from height and weight.
|
Calculated 4 times; baseline, 3-months, 6-months and 12 months
|
Community Adoption
Time Frame: 1 time at 3 months
|
Number of communities and community organizations that respond to a call for applications
|
1 time at 3 months
|
Cohort Adoption
Time Frame: up to 24 months
|
The number of cohorts initiated in each community
|
up to 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost
Time Frame: up to 24 months
|
Cost of program adoption and implementation for communities will be tracked over the study using time tracking software to capture time spent on program activities for implementation staff.
|
up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennie Hill, PhD, University of Nebraska
- Principal Investigator: Kate Heelan, PhD, University of Nebraska at Kearney
Publications and helpful links
General Publications
- Michaud TL, Hill JL, Heelan KA, Bartee RT, Abbey BM, Malmkar A, Masker J, Golden C, Porter G, Glasgow RE, Estabrooks PA. Understanding implementation costs of a pediatric weight management intervention: an economic evaluation protocol. Implement Sci Commun. 2022 Apr 5;3(1):37. doi: 10.1186/s43058-022-00287-1.
- Hill JL, Heelan KA, Bartee RT, Wichman C, Michaud T, Abbey BM, Porter G, Golden C, Estabrooks PA. A Type III Hybrid Effectiveness-Implementation Pilot Trial Testing Dissemination and Implementation Strategies for a Pediatric Weight Management Intervention: The Nebraska Childhood Obesity Research Demonstration Project. Child Obes. 2021 Sep;17(S1):S70-S78. doi: 10.1089/chi.2021.0170.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 121919-1
- 1U18DP006431 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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