Postpartum Weight RetentionNCT05619705
Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women
A study testing Healthy for Two-Health Coaching (H42) and Maintain Healthy in Pregnancy and Postpartum(mHIPP) in people with Postpartum Weight Retention and Pregnancy Weight Gain, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Weight Retention, Pregnancy Weight Gain, Overweight and Obesity
- What is being tested?
- Healthy for Two-Health Coaching (H42) and Maintain Healthy in Pregnancy and Postpartum(mHIPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
Becka Richman, MSN/MPH, 443-931-5082, rrichma1@jh.edu
About this study
Official title: Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services
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.
Read the detailed description
There are four components of the H42-HV intervention: 1) Health coaching calls; 2) H42 web-based app for learning activities and goal setting functions; 3) Tracking of health behaviors (diet, exercise), and 4) Self-weighing (weekly). The overarching behavioral goals of the intervention are for participants to have lower postpartum weight retention at 6 months after delivery. Weight and behavioral goals will be promoted through the COACH Plan, a behavioral model guiding coaching calls, behavioral tracking targets and learning activities. Coaches will refer to home visitors for additional support and community resources, based on an established protocol.
- Telephone health coaching calls by trained health coaches. Calls start at enrollment, between 20-33-weeks gestation through 6 months postpartum. Although coaching calls will occur by phone or Zoom (~20 mins), when possible, some coach contact could occur at the time of home visits in person.
- Online interactive learning activities. Literacy adaptation ensured Learning Activities are at <5th grade reading level. All activities are translated into Spanish and culturally adapted to create a parallel program. Online learning activities contain embedded images (people and settings) that reflect the diversity of the investigators' target population, examples of activities that are readily available in the community and maximize the use of white space, large text and simple graphics to enhance readability and accessibility of the educational content. The investigators enhanced the platform to enable an interactive goal-setting functionality for participants to set health goals paced with participants' Learning Activities and calls. The online program is maintained and monitored by the study's health coach managers.
- Health behavior tracking (diet and exercise). Participants will receive specific skill-building on how to track diet and exercise behaviors via mainstream mobile app or paper/pencil, using procedures from the investigators' current trial. Coaches will be able to discuss tracking data with participants. Mainstream tracking apps are available in both Spanish and English.
- Weekly self-weighing. Participants will be asked to weigh themselves weekly at home using the participants' study scale.
- Conditions
- Postpartum Weight Retention, Pregnancy Weight Gain, Overweight and Obesity, Behavior, Health
- Being tested
- Healthy for Two-Health Coaching (H42), Maintain Healthy in Pregnancy and Postpartum(mHIPP)
- Keywords
- Behavioral Intervention, Early Childhood Home Visiting, Overweight, Obesity, Postpartum, Pregnancy
- Medical subject headings
- Gestational Weight Gain, Overweight, Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy for Two-Health Coaching (H42)Behavioural
The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
Maintain Healthy in Pregnancy and Postpartum(mHIPP)Behavioural
Also called "Usual Home Visiting Plus"
A brief video on maternal warning signs that is available in English or Spanish.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Maintain Healthy in Pregnancy and Postpartum(mHIPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months postpartum
Secondary outcomes (11)
Change in gestational weight (gain)
Difference between pre-pregnancy weight and delivery weight. Pre-pregnancy weight will be self-reported and then confirmed by prenatal clinic records. Delivery weight will be obtained via BodyTrace study scales provided to each participant.
Measured: Baseline and immediately before delivery
Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ)
Dietary intake will be assessed using the NHANES 2009-10 Dietary Screener Questionnaire (DSQ) Eating Habits Questionnaire (28-items). Scoring equations exist to estimate daily intake of fruits/vegetables, dairy, added sugars, whole grains, and calcium.
Measured: 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)
The Short Form International Physical Activity Questionnaire contains 9 items to collect data on health-related physical activity in the past seven days. Physical activity is categorized as high (at least one hour of moderate intensity exercise daily), moderate (approximately 30 minutes of moderate intensity exercise most days), or low (not meeting the criteria of high or moderate exercise).
Measured: 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)
A four-item portion of the PRAMS survey will be utilized to determine cigarette use before and during pregnancy.
Measured: Baseline
Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)
A 4-item portion of the CDC IFPS will be used at 2,4, and 6 months postpartum to assess current breastfeeding practice.
Measured: 2 months postpartum, 4 months postpartum, 6 months postpartum
Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)
A two-item portion of the CDC IFPS will be used to assess breastfeeding intention.
Measured: 37 weeks gestation
Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale
The Edinburgh Postpartum Depression scale is a 10-item measure assessing changes in mood over the past seven days. The last question related to suicidal ideation has been removed. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.
Measured: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item questionnaire assessing sleep habits in the past seven days. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score (0-21) and higher scores indicate worse sleep quality.
Measured: Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum
Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ)
The FSSQ is an 8-item measure that evaluates confidant support and affective support. Responses are scored 1-5 and an average is calculated based on the response from all eight items. A higher score indicates greater perceived social support.
Measured: Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum
Maternal healthcare utilization as assessed by Medicaid data extraction
Postpartum OBGYN visit and primary care provider visit by six months.
Measured: Up to 6 months after delivery
Infant healthcare utilization as assessed by Medicaid data extraction
Well-child visit appointments through six months of life.
Measured: Up to 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start25 Apr 2023
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Weight RetentionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Kelly Bower, PhD, MSN/MPH, Principal investigator, Johns Hopkins School of NursingWendy Bennett, MD,MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619705
- Sponsor's protocol ID
- IRB00307430
- Other IDs
- 1P50MD017348-01
- Status last verified
- Jun 2026
- First submitted
- 9 Nov 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39773922
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services
- ClinicalTrials.gov ID
- NCT05619705
- Acronym / sponsor ID
- IRB00307430
- Conditions
- Postpartum Weight Retention, Pregnancy Weight Gain, Overweight and Obesity, Behavior, Health
- Keywords
- Behavioral Intervention, Early Childhood Home Visiting, Overweight, Obesity, Postpartum, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
There are four components of the H42-HV intervention: 1) Health coaching calls; 2) H42 web-based app for learning activities and goal setting functions; 3) Tracking of health behaviors (diet, exercise), and 4) Self-weighing (weekly). The overarching behavioral goals of the intervention are for participants to have lower postpartum weight retention at 6 months after delivery. Weight and behavioral goals will be promoted through the COACH Plan, a behavioral model guiding coaching calls, behavioral tracking targets and learning activities. Coaches will refer to home visitors for additional support and community resources, based on an established protocol.
- Telephone health coaching calls by trained health coaches. Calls start at enrollment, between 20-33-weeks gestation through 6 months postpartum. Although coaching calls will occur by phone or Zoom (~20 mins), when possible, some coach contact could occur at the time of home visits in person.
- Online interactive learning activities. Literacy adaptation ensured Learning Activities are at <5th grade reading level. All activities are translated into Spanish and culturally adapted to create a parallel program. Online learning activities contain embedded images (people and settings) that reflect the diversity of the investigators' target population, examples of activities that are readily available in the community and maximize the use of white space, large text and simple graphics to enhance readability and accessibility of the educational content. The investigators enhanced the platform to enable an interactive goal-setting functionality for participants to set health goals paced with participants' Learning Activities and calls. The online program is maintained and monitored by the study's health coach managers.
- Health behavior tracking (diet and exercise). Participants will receive specific skill-building on how to track diet and exercise behaviors via mainstream mobile app or paper/pencil, using procedures from the investigators' current trial. Coaches will be able to discuss tracking data with participants. Mainstream tracking apps are available in both Spanish and English.
- Weekly self-weighing. Participants will be asked to weigh themselves weekly at home using the participants' study scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Healthy for Two-Health Coaching (H42) | Experimental | Behavioral: 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. |
| Maintain Health in Pregnancy and Postpartum (mHIPP) | Active comparator | Behavioral: Maintain Healthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy for Two-Health Coaching (H42)The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking. | Behavioural | Healthy for Two-Health Coaching (H42) |
| Maintain Healthy in Pregnancy and Postpartum(mHIPP)Also: "Usual Home Visiting Plus"A brief video on maternal warning signs that is available in English or Spanish. | Behavioural | Maintain Health in Pregnancy and Postpartum (mHIPP) |
Primary outcome
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.
11 secondary outcomes
Change in gestational weight (gain)
Time frame: Baseline and immediately before delivery
Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ)
Time frame: 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)
Time frame: 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)
Time frame: Baseline
Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)
Time frame: 2 months postpartum, 4 months postpartum, 6 months postpartum
Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)
Time frame: 37 weeks gestation
Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale
Time frame: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum
Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ)
Time frame: Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum
Maternal healthcare utilization as assessed by Medicaid data extraction
Time frame: Up to 6 months after delivery
Infant healthcare utilization as assessed by Medicaid data extraction
Time frame: Up to 6 months after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 39773922Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Bower, PhD, MSN/MPH principal investigator
Johns Hopkins School of Nursing
Wendy Bennett, MD,MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy for Two-Health Coaching (H42) and Maintain Healthy in Pregnancy and Postpartum(mHIPP) in people with Postpartum Weight Retention and Pregnancy Weight Gain, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly M Bower, PhD, MSN/MPH (410-955-4280, kbower1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postpartum weight (retention) (time frame: Baseline and 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.