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Health Coaching for Pregnancy Weight Gain

N/A

Recruiting

Led By Kelly Bower, PhD, MSN/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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Change in postpartum weight (retention)

Secondary outcome measures

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

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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,267 Previous Clinical Trials

14,837,187 Total Patients Enrolled

3 Trials studying Health Behaviors

1,210 Patients Enrolled for Health Behaviors

National Institute on Minority Health and Health Disparities (NIMHD)NIH

384 Previous Clinical Trials

1,216,108 Total Patients Enrolled

9 Trials studying Health Behaviors

4,156 Patients Enrolled for Health Behaviors

Kelly Bower, PhD, MSN/MPHPrincipal InvestigatorJohns Hopkins School of Nursing

Media Library

Healthy for Two-Home Visiting (H42-HV) Clinical Trial Eligibility Overview. Trial Name: NCT05619705 — N/A

Health Behaviors Research Study Groups: Healthy for Two-Health Coaching (H42), Maintain Health in Pregnancy and Postpartum (mHIPP)

Health Behaviors Clinical Trial 2023: Healthy for Two-Home Visiting (H42-HV) Highlights & Side Effects. Trial Name: NCT05619705 — N/A

Healthy for Two-Home Visiting (H42-HV) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05619705 — 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 openings still available for potential participants in this research?

"According to clinicaltrials.gov, this investigation has been actively recruiting since it was first posted on April 13th 2023 and last refreshed on the 25th of that same month."

Answered by AI

What is the current scope of this research endeavor with respect to participants?

"Indeed, the clinicaltrials.gov page for this trial reveals that it is open to enrolment as of April 25th 2023; having been initially announced on 13th April 2023. The research team seeks 500 volunteers from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women

2023. "Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05619705.

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