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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
Must not have
Active diagnosis of an eating disorder
Unable to walk 1 block without pain or shortness of breath
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months of age
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an eating disorder.
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I can't walk a block without feeling pain or getting out of breath.
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I have had severe preeclampsia or a baby born before 32 weeks.
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My blood pressure is not higher than 160/100 mmHg.
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I have had diabetes or been on diabetes medication before my first pregnancy visit.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total gestational weight gain
Secondary study objectives
Incidence of gestational diabetes mellitus
Infant weight
Number of participants who gained excess weight
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,328 Previous Clinical Trials
14,874,245 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,332,087 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
Gestational Diabetes Research Study Groups: Usual Care Comparison Group: Maintain Health in Pregnancy (mHIP), Healthy for Two/Healthy for You (H42/H4U)
Gestational Diabetes 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
~0 spots leftby Nov 2024
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