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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MD017348-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy for Two-Health Coaching (H42) | Behavioral | The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and immediately before delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Kelly Bower, PhD, MSN/MPH | Johns Hopkins School of Nursing | Principal Investigator |
| Wendy Bennett, MD,MPH | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Recruiting | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39773922 | Derived | 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. |
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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
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| Maintain Healthy in Pregnancy and Postpartum(mHIPP) | Behavioral | A brief video on maternal warning signs that is available in English or Spanish. |
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| 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. |
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 6 months after delivery |
| Infant healthcare utilization as assessed by Medicaid data extraction | Well-child visit appointments through six months of life. | Up to 6 months after delivery |
| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D050177 | Overweight |
| D009765 | Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011247 | Pregnancy |
| D049590 | Postpartum Period |
| ID | Term |
|---|---|
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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