Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05619705
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Healthy for Two-Health Coaching (H42) — BEHAVIORAL
    The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
  • Maintain Healthy in Pregnancy and Postpartum(mHIPP) — BEHAVIORAL
    A brief video on maternal warning signs that is available in English or Spanish.

Study Details

The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services in reducing postpartum weight retention (difference between pre-pregnancy weight and weight at 6 months postpartum) among pregnant and postpartum participants. The overall goal is to improve long-term cardiometabolic health.

Key Dates

Start date
Apr 25, 2023
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Healthy for Two-Health Coaching (H42)
    Those assigned to the intervention group will receive the 8 to 11 month H42 health coaching intervention in addition to usual home visiting and usual prenatal and postpartum care clinical services. Intervention duration will depend on the participant's gestational age at the of enrollment. Participants can be enrolled as early in pregnancy as 20 weeks gestation and as late as 33 weeks gestation. All participants would be enrolled for 6 months postpartum. Therefore, the minimum time in the intervention would be 8 months and maximum would be 11 months.
  • Active Comparator: Maintain Health in Pregnancy and Postpartum (mHIPP)
    Those assigned to the "usual home visiting plus" comparison group, called maintain health in pregnancy and postpartum (mHIPP), will receive the typical, evidence-based experience in participants' home visiting program in addition to the participants' usual prenatal and postpartum care clinical services. In addition, the investigators will provide a brief (less than 5 minutes) maternal warning signs educational video that is available in English or Spanish. The video was developed for a home visiting client audience and is publicly available, https://mdmom.org/warningsigns.

Primary Outcome Measure

Change in postpartum weight (retention) [ Time Frame: Baseline and 6 months postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of NursingBaltimoreMaryland21205
Becka Richman, MSN/MPH
[email protected]
443-931-5082

Find similar trials in Baltimore, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Johns Hopkins School of Nursing· Baltimore, MD

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