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

NCT05619705 | Recruiting DMC

• 2 other identifiers: IRB003074301P50MD017348-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in postpartum weight (retention)

  Difference between pre-pregnancy weight and weight at 6 months postpartum. Pre-pregnancy weight (baseline) will be self-reported and then confirmed by prenatal clinic medical records. 6 month postpartum weight will be obtained via BodyTrace study scales provided to all participants.

  Baseline and 6 months postpartum

Secondary Outcomes (11)

• Change in gestational weight (gain)

  Baseline and immediately before delivery

• Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ)

  Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum

• Change in maternal physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)

  Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum

• Maternal smoking habits as assessed by the Center for Disease Control and Prevention Pregnancy Risk Assessment Monitoring System (CDC PRAMS)

  Baseline

• Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)

  2 months postpartum, 4 months postpartum, 6 months postpartum

Study Arms (2)

Healthy for Two-Health Coaching (H42)

EXPERIMENTAL

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.

Behavioral: Healthy for Two-Health Coaching (H42)

Maintain Health in Pregnancy and Postpartum (mHIPP)

ACTIVE COMPARATOR

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.

Behavioral: Maintain Healthy in Pregnancy and Postpartum(mHIPP)

Interventions

Healthy for Two-Health Coaching (H42) BEHAVIORAL

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

Healthy for Two-Health Coaching (H42)

Maintain Healthy in Pregnancy and Postpartum(mHIPP) BEHAVIORAL

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

Also known as: "Usual Home Visiting Plus"

Maintain Health in Pregnancy and Postpartum (mHIPP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (1)

• Martin LM, McKinney CD, Escobar Acosta L, Coughlin JW, Jeffers NK, Solano-Umana A, Carson KA, Wang NY, Bennett WL, Bower KM. Remote Lifestyle Intervention to Reduce Postpartum Weight Retention: Protocol for a Community-Engaged Hybrid Type I Effectiveness-Implementation Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 7;14:e62847. doi: 10.2196/62847.

  PMID: 39773922 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain; Overweight; Obesity; Health Behavior

Interventions

Pregnancy; Postpartum Period

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Kelly Bower, PhD, MSN/MPH

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

• Wendy Bennett, MD,MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly M Bower, PhD, MSN/MPH

CONTACT

410-955-4280; kbower1@jhu.edu

Wendy Bennett, MD,MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The design of the study is a randomized, two parallel-arm clinical trial. The investigators will be applying principles of a hybrid type 1 effectiveness-implementation randomized control trial

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: April 25, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)