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Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I) (HEALTH D&I)

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ClinicalTrials.gov Identifier: NCT03758638
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE November 26, 2018
First Posted Date  ICMJE November 29, 2018
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE January 25, 2019
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Change in Weight [ Time Frame: 24-months ]
Mother's body weight assessed by data collector
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03758638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2018)
Fidelity of delivery to the intervention [ Time Frame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized ]
Parent educators' fidelity to the intervention will all be assessed using a coding document (developed for the current study), which will be applied to audio-recordings of study visits, and will document the following components: adherence, quality of delivery, exposure to the intervention, and participant responsiveness or involvement, all of which share a common unit of measure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Eating and Active Living Taught at Home (HEALTH) Dissemination & Implementation (D&I)
Official Title  ICMJE Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization
Brief Summary This project evaluates the effectiveness of an evidence-based intervention (HEALTH) to prevent weight gain and promote weight loss when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH is implemented within this national home visiting organization. This partnership has potential for significant impact on obesity and chronic diseases such as cardiovascular disease and diabetes.
Detailed Description Excessive weight gain among young adult women age 18-35 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period women tend to gain disproportionally large amounts of weight compared to men and other life periods. A lifestyle modification intervention (HEALTH) that prevented weight gain, promoted sustained weight loss, and reduced waist circumference was developed in partnership with Parents as Teachers (PAT), a national home visiting, community based organization with significant reach in this population. PAT provides parent-child education and services free-of-charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten. This study will extend these findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation of HEALTH across three levels (mother, parent educator, PAT site) to achieve widespread impact. The pragmatic cluster randomized controlled trial will evaluate HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the US (N= 252 HEALTH; N= 252 usual care). Parent educators from 28 existing PAT sites (14 HEALTH, 14 usual care) will receive the HEALTH training curriculum through the PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation research will characterize determinants that influence HEALTH dissemination and implementation at three levels: mother, parent educator, PAT site to enhance external validity (reach and maintenance) and population level impact. The findings from this innovative study will have significant potential to help reverse the trend of excessive weight gain among young adult women, a critical priority target in battling the epidemics of obesity and chronic disease, by reaching women with an evidence-based intervention nation-wide.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Healthy Eating & Active Living Taught at Home (HEALTH) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: Healthy Eating & Active Living Taught at Home
    PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
  • Behavioral: Usual Care
    The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
    Other Name: Parents as Teachers
Study Arms  ICMJE
  • Experimental: Healthy Eating & Active Living Taught at Home

    PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum (implementation strategy).

    Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits.

    Intervention: Behavioral: Healthy Eating & Active Living Taught at Home
  • Active Comparator: Usual Care
    Participants at usual care PAT sites will receive PAT as usual
    Intervention: Behavioral: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2018)
728
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For Parent educators:

Inclusion Criteria:

  • Deliver PAT at a site participating in the study
  • Provide informed consent

Exclusion Criteria:

  • At least 18 years of age

For Participants:

Inclusion Criteria:

  • 18-45 years of age
  • overweight or obese (BMI 25-45 kg/m2)
  • English or Spanish speaking
  • participating or willing to participate in PAT at a participating PAT site for 2 years
  • able to give informed consent for participation

Exclusion Criteria:

  • currently pregnant or planning to become pregnant in the next 24 months
  • unable to speak English or Spanish
  • unable to engage in a walking program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: For the participants (i.e., not the parent educators), only women will be included: Including only female participants is scientifically justified, as the study focus is addressing the dramatic weight gain women experience in early adulthood, which is not experienced to the same extent among men. Further, HEALTH was tested and demonstrated effectiveness only in mothers, and the very small number of fathers who participate in PAT will not provide an adequate sample to evaluate HEALTH in this population.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rachel G Tabak, PhD, RD 3149350153 rtabak@wustl.edu
Contact: Cindy D Schwarz, MPH, MS, RD 314-935-3063 cschwarz@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03758638
Other Study ID Numbers  ICMJE 201810157-1R01HL143360
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:
  • Only data with identifiers removed will be shared publicly.
  • Any identified data to be shared will only be done so in coordination with the Human Research Protection Office at Washington University in St. Louis and the Institutional Review Board (IRB) at the requesting investigator's institution.
  • Datasets with identifiers will only be accessible to study team members with appropriate Human Subjects training.
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachel G Tabak, PhD, RD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP