Health Coaching to Prevent Excessive Weight Gain during Pregnancy

(H42/H4U Trial)

Recruiting at 1 trial location

Overseen By NaeYuh Wang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Diabetes medications

Disqualifiers: Diabetes, Severe mental illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 37 weeks (pregnancy) + 12 weeks (postpartum)

380 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking diabetes medication or have a history of severe mental illness that is not well controlled, you may not be eligible to participate.

What data supports the effectiveness of the treatment Healthy for Two/Healthy for You (H42/H4U) in preventing excessive weight gain during pregnancy?

Research suggests that health coaching programs, like Healthy for Two/Healthy for You, can help pregnant women manage their weight gain effectively. Studies show that women who participated in health coaching were more likely to gain weight within the recommended range compared to those who received only information. ^{1 2 3 4 5}

Is health coaching safe for pregnant women to prevent excessive weight gain?

Health coaching, including telephone-based programs, has been used to support pregnant women in managing weight gain and is generally considered safe. Participants in these programs have reported positive experiences, and healthcare providers have found them helpful in facilitating discussions about weight management during pregnancy. ^{1 2 4 5 6}

How does the Healthy for Two/Healthy for You treatment differ from other treatments for preventing excessive weight gain during pregnancy?

The Healthy for Two/Healthy for You treatment is unique because it uses a personalized health coaching approach, delivered through prenatal care clinics, to help manage gestational weight gain and reduce the risk of gestational diabetes. This program is designed to be integrated into routine prenatal care and focuses on supporting women from diverse backgrounds through tailored coaching sessions. ^{2 3 4 5 7}

What is the purpose of this trial?

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.

Research Team

Wendy L Bennett, MD, MPH

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for English-speaking pregnant women with a BMI ≥ 25, carrying one baby, who are less than 15 weeks into their pregnancy. They must have access to and be willing to use a smartphone, laptop or tablet, and email for the study. Women with multiple fetuses, severe mental illness, substance abuse issues (except THC), poorly controlled blood pressure or pre-existing diabetes are excluded.

Inclusion Criteria

Has email address and willing to use for this study

I have a smartphone, laptop, or tablet and am willing to use it for the study.

I am less than 15 weeks pregnant and my prenatal weight and height are recorded.

Exclusion Criteria

No email address

I have been diagnosed with an eating disorder.

I can't walk a block without feeling pain or getting out of breath.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum

37 weeks (pregnancy) + 12 weeks (postpartum)

Remote sessions via phone and web-based platform

Follow-up

Participants are monitored for postpartum weight retention and infant weight at 6 months

6 months

Data collection through electronic health records

Treatment Details

Interventions

• Healthy for Two/Healthy for You

Trial Overview The 'Healthy for Two/Healthy for You' program is being tested in this trial. It's a health coach intervention delivered remotely through phone coaching and digital platforms aimed at preventing excessive weight gain during pregnancy and reducing gestational diabetes risk.

Participant Groups

Group I: Healthy for Two/Healthy for You (H42/H4U) Experimental Treatment 1 Intervention

Those assigned to the intervention group will receive the H42/H4U health coaching intervention during pregnancy and 12 weeks postpartum.

Group II: Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP) Active Control 1 Intervention

Those assigned to the Usual Care comparison group, mHIP, will receive typical, evidence- and guideline-based experience in the prenatal care clinics.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Nearly 50% of women exceed their recommended weight gain during pregnancy, with overweight and obese women being the most affected, which can lead to risks such as cesarean deliveries and large-for-gestational-age infants.

While interventions like diet and exercise during pregnancy can help reduce excessive weight gain, they have not significantly improved other maternal and neonatal outcomes, particularly in overweight and obese women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational weight gain. Kominiarek, MA., Peaceman, AM.[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 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 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]

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]

A structured program of dietary and lifestyle counseling during pregnancy significantly reduced weight gain compared to routine prenatal care, with the counseling group gaining an average of 28.7 lbs versus 35.6 lbs in the control group.

Women receiving lifestyle counseling had a lower rate of cesarean deliveries due to 'failure to progress' (25% vs. 58.3%), suggesting that dietary and lifestyle interventions may positively influence delivery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. Asbee, SM., Jenkins, TR., Butler, JR., et al.[2022]

The health coaching intervention for preventing excessive gestational weight gain (GWG) in 267 pregnant women did not effectively limit or prevent excessive GWG compared to usual care.

However, women in the health coaching group reported improved use of active coping skills, indicating some positive psychological and behavioral outcomes despite the lack of impact on weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a health coaching intervention delivered during pregnancy help prevent excessive gestational weight gain? Hill, B., Skouteris, H., Fuller-Tyszkiewicz, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gestational weight gain. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Piloting a Telephone Based Health Coaching Program for Pregnant Women: A Mixed Methods Study. [2020]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Personalized health planning with integrative health coaching to reduce obesity risk among women gaining excess weight during pregnancy. [2022]

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing excessive weight gain during pregnancy through dietary and lifestyle counseling: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Can a health coaching intervention delivered during pregnancy help prevent excessive gestational weight gain? [2021]