Skip to content

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

Disseminating and Implementing A Lifestyle Based Healthy Weight Program in a National Organization

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03758638
Acronym
HEALTH D&I
Enrollment
620
Registered
2018-11-29
Start date
2019-01-25
Completion date
2025-06-30
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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= 200 HEALTH; N= 200 usual care). Parent educators from 40 existing PAT sites (20 HEALTH, 20 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.

Interventions

BEHAVIORALHealthy 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.

BEHAVIORALUsual 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Weight24-monthsMother's body weight assessed by data collector

Secondary

MeasureTime frameDescription
Fidelity of Delivery to the Interventionthroughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomizedParent 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
349
Usual Care
Participants at usual care PAT sites will receive PAT as usual 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.
271
Total620

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up6054
Overall StudyPregnancy1725
Overall StudyProtocol Violation20
Overall StudyProviders not included in the primary outcome.183128
Overall StudyWithdrawal by Subject82

Baseline characteristics

CharacteristicUsual CareHealthy Eating & Active Living Taught at HomeTotal
Age, Continuous
Age of participant
31.2 Years
STANDARD_DEVIATION 6.1
30.3 Years
STANDARD_DEVIATION 5.6
30.7 Years
STANDARD_DEVIATION 5.8
Age, Continuous
Age of provider
40.11 Years
STANDARD_DEVIATION 12.04
39.75 Years
STANDARD_DEVIATION 12.05
39.93 Years
STANDARD_DEVIATION 12.05
Baseline Weight
Weight of participants
79.7 Kg83.6 Kg81.4 Kg
Baseline Weight
Weight of providers
76.66 Kg78.02 Kg77.11 Kg
Ethnicity (NIH/OMB)
Ethnicity of participant
Hispanic or Latino
62 Participants68 Participants130 Participants
Ethnicity (NIH/OMB)
Ethnicity of participant
Not Hispanic or Latino
67 Participants89 Participants156 Participants
Ethnicity (NIH/OMB)
Ethnicity of participant
Unknown or Not Reported
14 Participants9 Participants23 Participants
Ethnicity (NIH/OMB)
Ethnicity of provider
Hispanic or Latino
36 Participants58 Participants94 Participants
Ethnicity (NIH/OMB)
Ethnicity of provider
Not Hispanic or Latino
80 Participants114 Participants194 Participants
Ethnicity (NIH/OMB)
Ethnicity of provider
Unknown or Not Reported
12 Participants11 Participants23 Participants
Race (NIH/OMB)
Race of participants
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Race of participants
Asian
1 Participants4 Participants5 Participants
Race (NIH/OMB)
Race of participants
Black or African American
15 Participants25 Participants40 Participants
Race (NIH/OMB)
Race of participants
More than one race
9 Participants5 Participants14 Participants
Race (NIH/OMB)
Race of participants
Native Hawaiian or Other Pacific Islander
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Race of participants
Unknown or Not Reported
49 Participants38 Participants87 Participants
Race (NIH/OMB)
Race of participants
White
66 Participants93 Participants159 Participants
Race (NIH/OMB)
Race of providers
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race of providers
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Race of providers
Black or African American
10 Participants20 Participants30 Participants
Race (NIH/OMB)
Race of providers
More than one race
0 Participants6 Participants6 Participants
Race (NIH/OMB)
Race of providers
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Race of providers
Unknown or Not Reported
28 Participants26 Participants54 Participants
Race (NIH/OMB)
Race of providers
White
88 Participants128 Participants216 Participants
Sex: Female, Male
Sex of participant
Female
143 Participants166 Participants309 Participants
Sex: Female, Male
Sex of participant
Male
0 Participants0 Participants0 Participants
Sex: Female, Male
Sex of provider
Female
128 Participants182 Participants310 Participants
Sex: Female, Male
Sex of provider
Male
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3490 / 271
other
Total, other adverse events
0 / 3490 / 271
serious
Total, serious adverse events
0 / 3490 / 271

Outcome results

Primary

Change in Weight

Mother's body weight assessed by data collector

Time frame: 24-months

ArmMeasureValue (MEAN)Dispersion
Healthy Eating & Active Living Taught at HomeChange in Weight-0.24 KgStandard Deviation 9.75
Usual CareChange in Weight0.49 KgStandard Deviation 11.87
Secondary

Fidelity of Delivery to the Intervention

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

Time frame: throughout intervention delivery, which can range from 2-4 years for parent educators depending on when their site is randomized

ArmMeasureCategoryValue (COUNT_OF_UNITS)
Healthy Eating & Active Living Taught at HomeFidelity of Delivery to the InterventionHigh67 Visit recordings
Healthy Eating & Active Living Taught at HomeFidelity of Delivery to the InterventionLow12 Visit recordings
Healthy Eating & Active Living Taught at HomeFidelity of Delivery to the InterventionOther/NA/Missing9 Visit recordings

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026