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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK122416-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.
Despite two decades of public health efforts to combat obesity, rates continue to rise and racial disparities persist. There is an urgent need to re-focus obesity prevention efforts onto young adults, particularly reproductive age women. 23% of women (vs. 13% of men) gain ≥20 kg from age 18 to 55 years, with the highest weight gain in African American women who gain > 1kg/year. Importantly, weight gain of ≥20 kg is associated with development of type 2 diabetes (DM), other obesity-related comorbidities and greater mortality. For women who become pregnant, pregnancy provides an important opportunity for obesity and DM prevention, as excessive gestational weight gain (GWG) and pregnancy complications [e.g. gestational diabetes (GDM)], increase future DM risk. Promoting healthy GWG through behavioral interventions may prevent these pregnancy complications, but importantly has great potential for long-term, sustainable benefits to prevent postpartum weight retention (PPWR) and future obesity and DM, in women and the women's children.
With the publication of the LIFE-Moms consortium's results, there is now strong evidence from efficacy trials showing that limiting GWG is achievable and associated with improved exercise and dietary behaviors. Several notable research gaps and next steps have emerged from the LIFE-Moms' studies, which the investigators address in this pragmatic trial. Because these studies were designed to test the efficacy of behavioral weight management on GWG, interventions were resource intensive (i.e. in-person counseling and with limited online and mobile technologies), without a focus on program implementation and sustainability in routine prenatal care settings and lacking intervention in the vulnerable postpartum period. To address these critical evidence gaps and reduce obesity associated with the pregnancy/postpartum periods, the next step is to integrate and test an evidence-based lifestyle intervention in pregnancy and postpartum that utilizes remote delivery of counseling, enables self-monitoring by patients using mobile and online technologies and supports obstetric providers and clinics to optimize care for women at high risk for obesity and future DM.
The investigators' experienced team created and tested Healthy for Two / Healthy for You (H42/H4U). H42/H4U is an innovative evidence-based pregnancy/postpartum health coaching intervention that is remotely-delivered (phone coaching using motivational interviewing + web-based platform + mobile phone behavioral tracking). The aim of this R18 pragmatic randomized controlled trial (RCT) is to embed H42/H4U into prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches and community health workers (CHWs), to test its effectiveness and implementation.
The investigators hypothesize that women in the H42/H4U arm will have lower GWG and lower rates of GDM, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable. The investigators will rigorously test this hypothesis through the following Specific Aims:
Aim 1. Test the effectiveness of H42/H4U integrated into prenatal care compared with Usual Care among 380 pregnant and postpartum women enrolled from 6 prenatal clinics on:
A. Primary outcome: GWG (37 week minus baseline pregnancy [≤15 week gestation] weight) B. Maternal secondary outcomes: Proportion with excessive GWG; GDM incidence; PPWR at 6 months after delivery C. Infant secondary outcomes: Weight at birth, 4 and 6 months. D. Other outcomes: Maternal health behaviors (diet, physical activity, breastfeeding); Maternal wellness (depression, sleep and stress)
Aim 2. Assess organizational factors that impact the implementation of the intervention into prenatal care clinics, including costs of intervention delivery and provider and staff satisfaction to inform future dissemination.
A. Provider and staff perspectives, including satisfaction, workflow barriers and potential for sustainability, using qualitative semi-structured interviews (n=15 at baseline and end of study).
B. Cost analysis to assess intervention delivery costs and the return on investment (ROI) of H42/H4U.
This study will advance a potentially powerful, prenatal care-based strategy to reduce obesity in young adult childbearing women and thereby the intergenerational effects on the women's children. The investigators' interdisciplinary team brings together engaged academic and community-based obstetricians, the investigators' health system's population health program and researchers with experience in developing, testing and implementing behavioral interventions in both pregnant and non-pregnant adults in real world settings to enable wide dissemination. Ultimately, the investigators' goal is to design and produce an effective and scalable behavioral strategy, integrated into clinical practice that will: 1) reduce excessive GWG and its associated pregnancy complications, 2) reduce future obesity, DM and other obesity-related complications in mothers and the mothers' children, and 3) ensure high quality care delivery that prevents obesity and DM through a population health approach to prenatal care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy for Two/Healthy for You (H42/H4U) | Experimental | Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum. |
|
| Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP) | No Intervention | Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy for Two/Healthy for You | Behavioral | ~10 month (early pregnancy to 12 weeks postpartum), remotely-delivered, behavioral lifestyle intervention including health coach contacts (via phone, videoconference, and email/MyChart) and an interactive web-based platform. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Total Gestational Weight Gain | Observed difference between weight (lbs) at 37 weeks and baseline first trimester weight, measured prior to 15 weeks gestation. | At 37 weeks in pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Incidence of Gestational Diabetes Mellitus | Defined and validated by electronic health record diagnosis. | At 37 weeks in pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy L Bennett, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Health System and University | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40752820 | Result | Drabo EF, McKinney CD, Martin LM, Nair D, Coughlin JW, Chen T, Borahay MA, Wang NY, Bennett WL. Protocol for the economic evaluation of the "Healthy for Two/Healthy for You" pragmatic lifestyle intervention in prenatal care to reduce gestational weight gain and gestational diabetes mellitus. Contemp Clin Trials. 2025 Sep;156:108037. doi: 10.1016/j.cct.2025.108037. Epub 2025 Jul 31. | |
| 34896296 | Result | Bennett WL, Coughlin JW, Henderson J, Martin S, Yazdy GM, Drabo EF, Showell NN, McKinney C, Martin L, Dalcin A, Sanders R, Wang NY. Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent obesity in the prenatal care setting. Contemp Clin Trials. 2022 Feb;113:106647. doi: 10.1016/j.cct.2021.106647. Epub 2021 Dec 8. |
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Of 534 pregnant women consented, 384 met the inclusion criteria and were randomized.
Participants were recruited based on clinical referral at 9 academic and community-based obstetrics practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy for Two/Healthy for You (H42/H4U) | Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum. |
| FG001 | Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP) | Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Full Maternal Follow-up Period |
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| Postpartum Infant Follow-up Period |
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Data collected for pregnant women only
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy for Two/Healthy for You (H42/H4U) | Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum. |
| BG001 | Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Observed Total Gestational Weight Gain | Observed difference between weight (lbs) at 37 weeks and baseline first trimester weight, measured prior to 15 weeks gestation. | Complete cases from the intention-to-treat population (all participants randomized to H42/H4U or mHIP with non-missing outcome data) at 37 weeks of gestation. | Posted | Mean | Standard Deviation | lb | At 37 weeks in pregnancy |
|
Baseline (<= 15 weeks of gestation) to end of follow-up (6 months postpartum)
Adverse events monitored for pregnant women and their infants. Per protocol, events affect both the mother and infant they are counted as one AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy for Two/Healthy for You (H42/H4U) | Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital heart defects in infant | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Life-threatening events or Inpatient hospitalization or prolongation of existing hospitalization or a persistent or significant disability/incapacity or congenital anomaly or birth defect or other important medical events based upon medical judgement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visits, hospitalizations or other events requiring medical evaluation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
Level of data missingness may introduce selection bias for the outcomes, and results based on multiple imputation should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Bennett | Johns Hopkins University | 4105026081 | wendy.bennett@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2026 | Jun 29, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000078064 | Gestational Weight Gain |
| D063766 | Pediatric Obesity |
| D016640 | Diabetes, Gestational |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| NOT COMPLETED |
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|
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI range 25- >=40. Lower number is better. | Count of Participants | Participants |
|
| Participant Prenatal recruitment practices | Types of obstetric practices from which participants were recruited, enrolled, and randomized into the study. | Count of Participants | Participants |
|
Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.
|
|
| Secondary | Observed Incidence of Gestational Diabetes Mellitus | Defined and validated by electronic health record diagnosis. | Complete cases from the intention-to-treat population (all participants randomized to H42/H4U or mHIP with non-missing outcome data) at 37 weeks of gestation. | Posted | Count of Participants | Participants | At 37 weeks in pregnancy |
|
|
|
| 0 |
| 374 |
| 3 |
| 374 |
| 24 |
| 374 |
| EG001 | Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP) | Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics. | 1 | 380 | 1 | 380 | 24 | 380 |
|
| Very pre-term infant at 24 weeks gestation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Placenta previa and postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Intrauterine fetal death at 37 weeks gestation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |