Packaging Building Healthy Families for Community Implementation

NCT ID: NCT04719442

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-06-01

Brief Summary

There is a large body of literature regarding efficacious intervention strategies for treating childhood obesity. Unfortunately, the degree to which efficacious programs have been packaged for translation in micropolitan and surrounding rural areas is unclear-an important issue when considering the prevalence of obesity is higher in rural areas when compared to urban areas. Epstein's Traffic Light Diet (TLD) is likely the most studied pediatric weight management intervention (PWMI) and has demonstrated efficacy across a wide range of randomized controlled trials in children 6-12 years of age. Building Healthy Families (BHF) is an adaptation of the TLD and has been implemented in a micropolitan city and achieved clinically and statistically significant reductions in child BMI z-score (-0.27±0.22)-a similar magnitude of effect relative to previous efficacy trials. The investigators have created 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 to adopt, adapt and sustain it in other micropolitan/rural communities. The primary aim is to collaboratively refine and develop an intervention package for the BHF that includes materials necessary for others to implement the intervention in new metropolitan/rural locations. The second aim is to perform a rigorous, mixed-methods pilot implementation 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 while determining factors that predict adoption, implementation and sustainability. The investigators will also use a learning collaborative implementation strategy to improve implementation fidelity and local context and facilitation capacity in communities interested in delivering BHF. 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. 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.

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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Building Healthy Families

Intervention Type: BEHAVIORAL

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.

BHF-Program Only

Four other communities will be assigned to receive the packaged PWMI and training program only.

Group Type: ACTIVE_COMPARATOR

Building Healthy Families

Intervention Type: BEHAVIORAL

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.

Interventions

Building Healthy Families

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Building Healthy Families-Program Only

Eligibility Criteria

Inclusion Criteria

• Child 6 to 12 years of age
• Child with BMI percentile at or above the 95th percentile

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennie Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Kate Heelan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska at Kearney

References

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.

Reference Type: DERIVED

PMID: 35382891 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34569848 (View on PubMed)

Other Identifiers

1U18DP006431

Identifier Type: NIH

Identifier Source: secondary_id

View Link

121919-1

Identifier Type: -

Identifier Source: org_study_id