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Behavioral Intervention

Health Coaching to Prevent Excessive Weight Gain during Pregnancy (H42/H4U Trial)

N/A

Recruiting

Led By Wendy L Bennett, MD, MPH

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age≥18

≤15 weeks gestation with documented prenatal weight and height in electronic health record

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months of age

Awards & highlights

H42/H4U Trial Summary

This trial is testing a new way to help pregnant women have healthier pregnancies by providing them with a health coach who they can talk to using their phone or computer. The coach will help motivate the woman and give her tips to improve her health during pregnancy. They will also track her progress using a mobile phone app. The investigators hope that this will help reduce rates of gestational diabetes and weight gain during pregnancy, without increasing the risk of low birth weight babies.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves lifestyle changes rather than medication, side effects may include typical challenges associated with diet change or increased physical activity but no medicinal side effects.

H42/H4U Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

H42/H4U Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total gestational weight gain

Secondary outcome measures

Incidence of gestational diabetes mellitus

Infant weight

Number of participants who gained excess weight

+2 more

H42/H4U Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Healthy for Two/Healthy for You (H42/H4U)Experimental Treatment1 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 Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,822,785 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,314,914 Total Patients Enrolled

Wendy L Bennett, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

Healthy for Two/Healthy for You (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04724330 — N/A

Childhood Obesity Research Study Groups: Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP), Healthy for Two/Healthy for You (H42/H4U)

Childhood Obesity Clinical Trial 2023: Healthy for Two/Healthy for You Highlights & Side Effects. Trial Name: NCT04724330 — N/A

Healthy for Two/Healthy for You (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04724330 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for participants in this trial?

"That is correct. According to the data posted on clinicaltrials.gov, this experiment began recruiting participants on March 15th 2021 and is still open to enrollment as of its most recent update from March 15th 2022; requiring 380 people at two centres."

Answered by AI

What is the sample size of this medical study?

"Affirmative. According to the clinicaltrials.gov database, this research is currently recruiting participants; it was posted on March 15th 2021 and has most recently been updated on that same date in 2022. This trial requires 380 individuals at 2 locations for enrolment purposes."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

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, Wendy L., Janelle W. Coughlin, Janice Henderson, Stephen Martin, Golsa M. Yazdy, Emmanuel F. Drabo, Nakiya N. Showell, et al.. 2022. “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”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106647.

Contemporary Clinical TrialsJournal

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

Contemporary Clinical TrialsJournal

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

clinicaltrials.govStudy

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

2021. "Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04724330.