Health Coaching for Pregnancy Weight Gain

Overseen By Wendy Bennett, MD,MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Insulin

Disqualifiers: Type 1 diabetes, Multiple fetuses, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 37

Duration: 8-11 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special home visiting program, called Healthy for Two-Home Visiting (H42-HV), helps new mothers lose baby weight more effectively than usual home visits. The focus is on reducing the weight difference observed before pregnancy and six months after giving birth, with the goal of enhancing long-term heart health. Participants will receive either H42-HV coaching or standard care, which includes a short educational video. This trial suits pregnant women with a single baby and a pre-pregnancy BMI (a measure of body fat based on height and weight) of 25 or more. As an unphased trial, it offers participants the chance to contribute to important research that could improve postpartum health for many women.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, if you have Type 1 diabetes or are taking insulin, you cannot participate in the trial.

What prior data suggests that the Healthy for Two-Home Visiting (H42-HV) and "Usual Home Visiting Plus" (mHIP-HV) methods are safe for pregnant and postpartum participants?

Research has shown that the Healthy for Two-Home Visiting (H42-HV) program has been used in other studies examining the integration of health coaching into prenatal care. So far, no reports of serious side effects or safety issues have emerged. The program primarily involves coaching and support, which are generally safe and well-tolerated. However, as this approach is relatively new, staying informed about any new research findings is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health Coaching for Pregnancy Weight Gain trial because it's exploring two innovative approaches to support healthy weight management during pregnancy and postpartum. The Healthy for Two-Home Visiting (H42-HV) program is notable for its personalized health coaching, which is tailored to the specific needs of pregnant individuals throughout their pregnancy and into the postpartum period, offering more direct support than the usual care. On the other hand, the Maintain Health in Pregnancy and Postpartum (mHIPP) program enhances standard home visiting care with a brief educational video about maternal warning signs, which can empower participants with crucial health information. These approaches aim to offer more comprehensive and engaging support options compared to traditional prenatal and postpartum care services.

What evidence suggests that this trial's treatments could be effective for reducing postpartum weight retention?

Research has shown that remote programs like Healthy for Two-Home Visiting (H42-HV), which participants in this trial may receive, can help women manage their weight during and after pregnancy. These programs provide guidance and support without requiring frequent in-person visits. Early results suggest that women in these programs better control their weight after giving birth. The coaching is tailored to fit into everyday life and is culturally relevant, which may enhance its effectiveness. Overall, these programs aim to improve long-term health by addressing weight issues early. Meanwhile, participants in the "Usual Home Visiting Plus" (mHIP-HV) arm will receive the standard, evidence-based experience in their home visiting program, along with a brief educational video on maternal warning signs. ^{2 6 7 8 9}

Who Is on the Research Team?

Kelly Bower, PhD, MSN/MPH

Principal Investigator

Johns Hopkins School of Nursing

Wendy Bennett, MD,MPH

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for Black and Latinx pregnant individuals with a pre-pregnancy BMI of 25 or higher, less than 33 weeks along, who speak English or Spanish. They must be enrolled in a home visiting program and willing to participate in health coaching. Excluded are those with Type 1 diabetes on insulin, multiple pregnancies, mobility issues, planned relocation within a year, active substance abuse (except marijuana), or recent psychiatric hospitalization.

Inclusion Criteria

Completion of screening and baseline data collection

Enrolled in participating home visiting program

Able to provide informed consent

Exclusion Criteria

Planning to relocate from area during next 1 year

Active eating disorder

Not cleared by the study's clinicians or home visiting program staff

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health coaching calls, use a web-based app for learning activities and goal setting, track health behaviors, and perform weekly self-weighing from 20-33 weeks gestation through 6 months postpartum

8-11 months

Regular phone or Zoom calls, with possible in-person contact during home visits

Follow-up

Participants are monitored for changes in postpartum weight retention, physical activity, breastfeeding practices, sleep habits, depression, smoking habits, diet, healthcare utilization, and social support

6 months postpartum

Assessments at baseline, 37 weeks gestation, 2, 4, and 6 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Healthy for Two-Home Visiting (H42-HV)
• "Usual Home Visiting Plus" (mHIP-HV)

Trial Overview The study compares the 'Healthy for Two-Health Coaching' integrated into regular home visits against standard services alone. It focuses on reducing weight retention six months postpartum among participants to improve cardiometabolic health outcomes.

How Is the Trial Designed?

Group I: Healthy for Two-Health Coaching (H42) Experimental Treatment 1 Intervention

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.

Group II: Maintain Health in Pregnancy and Postpartum (mHIPP) Active Control 1 Intervention

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.

Healthy for Two-Home Visiting (H42-HV) is already approved in United States for the following indications:

Approved in United States as Healthy for Two-Home Visiting for:

• Postpartum weight retention prevention
• Cardiometabolic health improvement

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The Healthy Homes/Healthy Kids Preschool pilot program showed high completion and satisfaction rates among 60 parent-child dyads, indicating that a pediatric primary care-based approach to obesity prevention is feasible and acceptable.

While the overall intervention did not show a significant effect on BMI for all participants, it was particularly effective for children who were already overweight at baseline, suggesting targeted interventions may be beneficial for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study. Sherwood, NE., JaKa, MM., Crain, AL., et al.[2018]

Clients in the Wisconsin Health Department's Prenatal Care Coordination program reported high satisfaction with the services, primarily valuing the supportive nurse-client relationship and the information provided.

Most clients entered the program without specific expectations, indicating that the program's effectiveness may rely more on the quality of support and resources rather than pre-defined goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences in a prenatal home visiting program: A prenatal care coordination program evaluation. Heitzman, M., Weitzel, J., Kroll, S., et al.[2020]

A 27-year research program involving prenatal and infancy home visiting by nurses has successfully improved parental care and child development outcomes for low-income mothers, leading to fewer injuries and better emotional and language development in infants.

The program has also positively impacted maternal life courses, resulting in fewer subsequent pregnancies, increased workforce participation, and reduced reliance on public assistance, although its effects on pregnancy outcomes were less clear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nurse-family partnership: An evidence-based preventive intervention. Olds, DL.[2022]

The Nurse Home Visitation Program significantly benefits low-income unmarried mothers by reducing rates of childhood injuries and neglect, helping them delay subsequent pregnancies, and improving their economic self-sufficiency, as shown in randomized trials in Elmira and Memphis.

Long-term follow-up indicates that mothers who received nurse visits were less likely to abuse their children and had children who experienced fewer arrests and substance use, highlighting the program's effectiveness in promoting healthier family dynamics and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal and infancy home visitation by nurses: recent findings. Olds, DL., Henderson, CR., Kitzman, HJ., et al.[2022]

A case study of a 32-year-old woman who gained excess weight during pregnancy showed that a 6-month personalized health planning with integrative health coaching (PHP-IHC) intervention improved her physical activity, energy expenditure, and confidence in health-promoting behaviors.

Although she did not reach her target weight by the end of the coaching sessions, follow-up 8 months later revealed she achieved her goal, suggesting that PHP-IHC can effectively support postpartum weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized health planning with integrative health coaching to reduce obesity risk among women gaining excess weight during pregnancy. Yang, NY., Wroth, S., Parham, C., et al.[2022]

In a study of 325 children, those receiving home visits (HV) showed a significantly lower prevalence of early childhood caries (ECC) at 24 months (1.5%) compared to those receiving telephone contacts (TC) (6.8%) and reference controls (RC) (22.5%).

Children in the HV group also had a lower colonization rate of mutans streptococci (28%) compared to the TC (47%) and RC (35%) groups, indicating that HV may be more effective in promoting oral health in early childhood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled, longitudinal study of home visits compared to telephone contacts to prevent early childhood caries. Plonka, KA., Pukallus, ML., Barnett, A., et al.[2022]

Home visiting programs (HV) did not show an overall effect on birth outcomes for second children, but they did improve prenatal care for Black women and reduce Cesarean section rates for Hispanic women in the program.

For women with a preterm first birth, HV was associated with a lower risk of prematurity in their second child, indicating that these programs may help mitigate some negative social determinants of health for marginalized groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birth-Related Outcomes for Second Children Following Home Visiting Program Enrollment for New Parents of First Children. Holland, ML., Condon, EM., Rinne, GR., et al.[2022]

In a study involving 923 pregnant women, those who received telephone-based health coaching were more likely to gain weight within the target range for their BMI by 36 weeks of gestation (42.9%) compared to those who only received information (31.9%).

Participants reported that the GHiP program was useful and supportive, indicating that integrating telephone-based lifestyle coaching with routine clinical care could help pregnant women manage healthy weight gain, although the difference in outcomes between the two service options was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting a Telephone Based Health Coaching Program for Pregnant Women: A Mixed Methods Study. Rissel, C., Khanal, S., Raymond, J., et al.[2020]

The Get Healthy in Pregnancy Service aims to support pregnant women in achieving appropriate weight gain through a telephone-based health coaching program, comparing its effectiveness against providing information only in a trial involving 710 women.

This study addresses the high prevalence of excessive gestational weight gain in Australia and seeks to implement a practical intervention that combines health coaching with routine antenatal care, potentially leading to better maternal and child health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic cluster randomised trial of a free telephone-based health coaching program to support women in managing weight gain during pregnancy: the Get Healthy in Pregnancy Trial. Clements, V., Leung, K., Khanal, S., et al.[2023]

The Healthy for Two/Healthy for You (H42/H4U) health coaching program is being tested in a randomized clinical trial with 380 pregnant women to see if it can reduce total gestational weight gain (GWG) and lower rates of gestational diabetes mellitus (GDM) compared to usual prenatal care.

This study aims to provide real-world evidence on the effectiveness of the H42/H4U program, which could lead to improved maternal and child health outcomes and help prevent obesity in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bennett, WL., Coughlin, JW., Henderson, J., et al.[2023]

A pilot home visiting program in a disadvantaged suburb of Sydney showed that nurses provided essential emotional support and information on health and infant development to families, leading to significant improvements in their access to support services.

The program successfully increased clients' self-efficacy and social networks, demonstrating that home visiting can empower vulnerable families to manage daily challenges more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained health home visiting can improve families' social support and community connectedness. Stubbs, JM., Achat, HM.[2017]

The HIPP Study will evaluate the effectiveness of a specialized health coaching intervention in preventing excessive weight gain during pregnancy and postpartum weight retention, involving 220 women with a BMI over 18.5.

The study aims to assess not only weight management outcomes but also psychological factors like motivation and body dissatisfaction, providing insights into how health coaching can support women during and after pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study. Skouteris, H., McCabe, M., Milgrom, J., et al.[2021]

Higher therapeutic alliance ratings between clinicians and clients at the 3-month mark were associated with longer treatment retention for mothers receiving Infant Mental Health services, indicating the importance of strong relationships in healthcare outcomes.

Black clinicians reported higher alliance ratings with clients compared to white clinicians, suggesting that racial bias may affect the therapeutic relationship and contribute to health disparities, particularly for Black mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Racial Biases: Preliminary Investigation on Predictors of Poor Therapeutic Alliance and Retention in Home Visiting Intervention Program. Torres, C., Rosenblum, KL., Jester, JM., et al.[2023]

Four years after the Healthy School Start intervention, no significant overall effects on dietary intake, screen time, physical activity, or BMI were found among the entire group of children, indicating limited long-term effectiveness of the program.

However, some subgroup effects were noted: girls showed a lower intake of unhealthy foods, while boys above the 95th percentile had higher BMI in the intervention group, suggesting that the intervention's impact varied by gender and initial weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial. Norman, Å., Zeebari, Z., Nyberg, G., et al.[2023]

Citations

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Remote Lifestyle Intervention to Reduce Postpartum Weight ... Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in groups of ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05619705/healthy-for-two-home-visiting-h42-hv-health-coaching-for-pregnant-women

Healthy for Two-Home Visiting (H42-HV): Health Coaching ... The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services ...

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Remote Lifestyle Intervention to Reduce Postpartum ... Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested ...

4. researchgate.net researchgate.net/publication/356881434_Healthy_for_TwoHealthy_for_You_Design_and_methods_for_a_pragmatic_randomized_clinical_trial_to_limit_gestational_weight_gain_and_prevent_obesity_in_the_prenatal_care_setting

Design and methods for a pragmatic randomized clinical ... ... Healthy for Two–Home Visiting or usual home visiting services. The primary outcome is weight retention at 6 months post partum, calculated ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421003839

Design and methods for a pragmatic randomized clinical ... The goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two–Home Visiting) implemented within ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05619705

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

7. researchprotocols.org researchprotocols.org/2025/1/e62847

Remote Lifestyle Intervention to Reduce Postpartum ... Objective: The goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two–Home ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34896296/

Design and methods for a pragmatic randomized clinical trial ... This pragmatic clinical trial embeds a pregnancy health coaching program into prenatal care to allow parallel testing compared to usual prenatal care.

9. medicine-matters.blogs.hopkinsmedicine.org medicine-matters.blogs.hopkinsmedicine.org/2023/07/harnessing-pregnancy-as-a-catalyst-for-positive-change/

Harnessing Pregnancy as a Catalyst for Positive Change The team draws from past experience designing and testing Healthy for Two (H42), an evidence-based pregnancy/postpartum health coaching ...