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Pediatric ObesityNECORDNCT04719442

Packaging Building Healthy Families for Community Implementation

A study testing Building Healthy Families in people with Pediatric Obesity, run by University of Nebraska.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity
What is being tested?
Building Healthy Families
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jun 2021to 1 Jun 2021
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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Translating Efficacious Pediatric Weight Management Interventions Into Rural & Micropolitan Communities

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.

Read the 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.

Being tested
Building Healthy Families
Keywords
Obesity, Type III Hybrid Effectiveness Implementation, Rural
Medical subject headings
Pediatric Obesity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Building Healthy FamiliesBehavioural

    Also called Building Healthy Families-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.

Study groups in NCT04719442
Study groupRoleWhat they receive
BHF-LCExperimentalTo 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).
Receives: Behavioral: Building Healthy Families
BHF-Program OnlyActive comparatorFour other communities will be assigned to receive the packaged PWMI and training program only.
Receives: Behavioral: Building Healthy Families

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Program Implementation

    % of objectives met during intervention sessions

    Measured: up to 12 weeks

Secondary outcomes (7)
  1. Body Mass Index percentile ranking

    Using standardized calculation for degree of childhood obesity as a function of height, weight, age and gender

    Measured: Calculated four times, baseline, 3-months, 6-months and 12 months

  2. Reach

    number of children enrolled

    Measured: measured once at enrollment

  3. Height in Meters

    Measured in adults using a standard stadiometer

    Measured: Measured once at baseline

  4. Weight in Kilograms

    Measured in adults using a research grade scale

    Measured: Measured 4 times; baseline, 3 months, 6-months and 12 months.

  5. Body Mass Index

    Calculated for adults from height and weight.

    Measured: Calculated 4 times; baseline, 3-months, 6-months and 12 months

  6. Community Adoption

    Number of communities and community organizations that respond to a call for applications

    Measured: 1 time at 3 months

  7. Cohort Adoption

    The number of cohorts initiated in each community

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Jun 2021
  4. Study completion1 Jun 2021

Why it stopped: Started record under wrong IRB account. Registered under UNMC, but actually at UNKearney.

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04719442
Sponsor's protocol ID
121919-1
Other IDs
1U18DP006431
Acronym
NECORD
Status last verified
Aug 2024
First submitted
2 Jul 2020
Last updated
3 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data collected during the trial after deidentification.

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.

    PubMed 35382891
  • 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.

    PubMed 34569848

Questions about this trial

What is this clinical trial studying?

A study testing Building Healthy Families in people with Pediatric Obesity, run by University of Nebraska.

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 3 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: withdrawn, as of the sponsor's last update on 3 Sep 2024. 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 was withdrawn before enrolling participants, so there are no results.

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?

Program Implementation (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04719442, which also lists 2 linked publications.

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 3 Sep 2024.

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