NCT05619705 · Johns Hopkins University
Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Healthy for Two-Health Coaching (H42)
The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
BEHAVIORAL
Maintain Healthy in Pregnancy and Postpartum(mHIPP)
A brief video on maternal warning signs that is available in English or Spanish.
Primary outcome measures
Change in postpartum weight (retention)
Time frame: Baseline and 6 months postpartum
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations