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Health Coaching for Pregnancy Weight Gain

N/A

Recruiting

Led By Wendy 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial compares home visiting services with an extra intervention aimed to reduce postpartum weight retention in Black and Latinx pregnant & postpartum women to address cardiometabolic health inequities.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like health coaching and monitoring rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience stress or discomfort related to lifestyle changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in postpartum weight (retention)

Secondary study objectives

Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)

Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)

Gestational Weight Gain

+8 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-Health Coaching (H42)Experimental Treatment1 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 Control1 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.

Do I qualify?Apply below to find out