Recruiting

Health Coaching

Sponsor:

Johns Hopkins University

Code:

NCT05619705

Conditions

Postpartum Weight Retention

Pregnancy Weight Gain

Overweight and Obesity

Behavior, Health

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Healthy for Two-Health Coaching (H42)

Maintain Healthy in Pregnancy and Postpartum(mHIPP)

Study Details

Brief summary:

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.

Conditions

Postpartum Weight Retention

Pregnancy Weight Gain

Overweight and Obesity

Behavior, Health

Study ID

NCT05619705

Start date

Apr 25, 2023

Status verified date

Jun, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant, ≤33 weeks gestation
  • Singleton pregnancy
  • Pre pregnancy BMI≥25.0 Kg/m\^2 (calculated based on self-reported pre pregnancy height and weight)
  • Able to provide informed consent
  • English or Spanish speaking
  • Completion of screening and baseline data collection
  • Willing to participate in the intervention and data collection procedure (e.g., home weights)

Exclusion Criteria:

  • Type 1 diabetes or taking insulin prior to delivery
  • Pregnant with multiple fetuses
  • Unable to walk 1 block without pain or shortness of breath
  • Not cleared by the study's clinicians or home visiting program staff
  • Planning to relocate from area during next 1 year
  • Active substance abuse disorder (except marijuana)
  • Psychiatric or substance use related hospitalization in past 1 year
  • Active eating disorder

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Healthy for Two-Health Coaching (H42)

The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.

Maintain Healthy in Pregnancy and Postpartum(mHIPP)

A brief video on maternal warning signs that is available in English or Spanish.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kelly M Bower, PhD, MSN/MPH

410-955-4280kbower1@jhu.edu

Wendy Bennett, MD,MPH

410-502-6081wendy.bennett@jhmi.edu

Locations

Johns Hopkins School of Nursing

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Becka Richman, MSN/MPH

443-931-5082rrichma1@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Behavioral Intervention
  • Early Childhood Home Visiting
  • Overweight
  • Obesity
  • Postpartum
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-08.