NCT04253977

Brief Summary

This project evaluates the effectiveness of an evidence-based intervention (HEALTH-P2) to prevent excessive weight gain from pregnancy through 12 months postpartum when disseminated and implemented in real-world settings, through Parents as Teachers. To enhance the impact of HEALTH-P2, the study also evaluates implementation outcomes from the training curriculum (implementation strategy) and external validity when HEALTH-P2 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
784

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Feb 2020

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

5.2 years

First QC Date

January 31, 2020

Last Update Submit

October 11, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in weight

    Mother's body weight

    12 months postpartum

Secondary Outcomes (1)

  • Fidelity of delivery to the intervention

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

Study Arms (2)

HEALTH-P2

EXPERIMENTAL

Along with PAT National Center, parent educators affiliated with PAT sites in HEALTH-P2; with be trained to use the HEALTH-P2 training curriculum (implementation strategy).

Behavioral: HEALTH-P2

Usual Care

ACTIVE COMPARATOR

Participants at usual care PAT sites will receive PAT as usual.

Behavioral: Usual Care

Interventions

HEALTH-P2BEHAVIORAL

The HEALTH-P2 curriculum includes evidence based lifestyle change strategies to prevent excess gestational weight gain and postpartum weight retention embedded within and delivered as part of home visits.

HEALTH-P2
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFor 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 gestational weight gain.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • At least 18 years of age
  • For the participants:
  • years of age
  • pregnant
  • overweight or obese (BMI over 25 kg/m2) before becoming pregnant
  • English or Spanish speaking
  • participating or willing to participate in PAT at a participating PAT site until baby turns 1
  • able to give informed consent for participation
  • planning to become pregnant again before their baby turns 1
  • unable to engage in a walking program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra Haire-Joshu, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Rachel G Tabak, PhD, RD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Tabak, PhD, RD

CONTACT

314-935-0153rtabak@wustl.edu

Cindy Schwarz, MPH,MS,RD

CONTACT

3149353063cschwarz@wustl.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Healthy Eating \& Active Living Taught at Home during Pregnancy and Postpartum (HEALTH-P2) embeds content related to healthy eating and activity within Parents as Teachers (PAT)'s existing home visits.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

February 3, 2020

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

US(1)