Health Coaching to Prevent Excessive Weight Gain during Pregnancy

(H42/H4U Trial)

No longer 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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a health coaching program called "Healthy for Two/Healthy for You" to help pregnant women manage weight gain and reduce the risk of gestational diabetes. The program includes phone coaching, a web platform, and mobile tracking to provide support during and after pregnancy. Participants will receive either this new coaching intervention or standard prenatal care to determine which is more effective. Women who are less than 15 weeks pregnant with a single baby, have a body mass index (BMI) of 25 or higher, and can use a smartphone or computer may be eligible. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance prenatal care for many women.

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 prior data suggests that the H42/H4U health coaching intervention is safe for pregnant women?

Research has shown that the "Healthy for Two/Healthy for You" (H42/H4U) program helps pregnant women manage weight gain. It employs phone-based health coaching and online tools. This method relies on behavioral counseling, which has proven effective in controlling excess weight gain during pregnancy and improving health.

The program guides women to make healthier choices without physical treatments or medications. Since it involves coaching, no safety issues or negative effects have been reported. This makes the program a safe option for expecting mothers who want to manage their weight during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy for Two/Healthy for You (H42/H4U) health coaching program because it offers a personalized approach to preventing excessive weight gain during pregnancy. Unlike standard prenatal care, which primarily focuses on medical check-ups and general advice, H42/H4U provides targeted health coaching both during pregnancy and for 12 weeks postpartum. This program emphasizes individualized support and guidance, aiming to create sustainable lifestyle changes that benefit both the mother and the baby. By focusing on personal coaching, the program hopes to address the root causes of excessive weight gain and improve overall pregnancy health.

What evidence suggests that the Healthy for Two/Healthy for You intervention is effective for preventing excessive weight gain during pregnancy?

Studies have shown that certain programs can help manage weight gain during pregnancy. For example, a simple program helped women gain less weight and avoid retaining extra weight after giving birth. In this trial, participants in the intervention group will receive the Healthy for Two/Healthy for You (H42/H4U) program, which uses methods like motivational coaching and tracking tools. Research shows these methods can lead to healthier weight and lower chances of developing gestational diabetes, a type of diabetes that starts during pregnancy. The U.S. Preventive Services Task Force recommends these programs to help pregnant women gain weight in a healthy way. ^{2 3 4 5 6}

Who Is on the Research Team?

Wendy L Bennett, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04724330

Pragmatic Randomized Clinical Trial to Limit Weight Gain ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3057546/

Randomized trial of a behavioral intervention to prevent ... A low-intensity behavioral intervention during pregnancy reduced excessive gestational weight gains in NW women and prevented postpartum weight retention in NW ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2780318

Behavioral Counseling Interventions for Healthy Weight ... The USPSTF recommends that clinicians offer pregnant persons effective behavioral counseling interventions aimed at promoting healthy weight gain and ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT03551054?keyword=%22Weight%20Gain%22

San Mateo Clinical Trial Healthy for Two, Healthy for You Half of pregnant women are overweight or obese. Obesity disproportionately impacts low-income women and women of racial and ethnic minorities.

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

Design and methods for a pragmatic randomized clinical trial ... Healthy for Two/Healthy for You: Design and methods for a pragmatic randomized clinical trial to limit gestational weight gain and prevent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8844210/

Design and Methods for a Pragmatic Randomized Clinical ... Healthy for 2/Healthy for You (H42/H4U) is a parallel arm, pragmatic randomized controlled trial in early pregnancy through 6 months after delivery (N=380) that ...