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

Overweight and Obesity Clinical Trial

Official title: Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services

Status Recruiting

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of H42-HV integrated into home visiting compared with usual home visiting services in reducing postpartum weight retention (difference between pre-pregnancy weight and weight at 6 months postpartum) among pregnant and postpartum people. The intervention is tailored for Black and Latinx pregnant and postpartum people and, ultimately, aims to address inequities in cardiometabolic health.

Clinical Trial Description

There are four components of the H42-HV intervention: 1) Health coaching calls; 2) H42 web-based app for learning activities and goal setting functions; 3) Tracking of health behaviors (diet, exercise), and 4) Self-weighing (weekly). The overarching behavioral goals of the intervention are for participants to have lower postpartum weight retention at 6 months after delivery. Weight and behavioral goals will be promoted through the COACH Plan, a behavioral model guiding coaching calls, behavioral tracking targets and learning activities. Coaches will refer to home visitors for additional support and community resources, based on an established protocol.

• Telephone health coaching calls by trained health coaches. Calls start at enrollment, between 20-33-weeks gestation through 6 months postpartum. Although coaching calls will occur by phone or Zoom (~20 mins), when possible, some coach contact could occur at the time of home visits in person.

• Online interactive learning activities. Literacy adaptation ensured Learning Activities are at <5th grade reading level. All activities are translated into Spanish and culturally adapted to create a parallel program. Online learning activities contain embedded images (people and settings) that reflect the diversity of the investigators' target population, examples of activities that are readily available in the community and maximize the use of white space, large text and simple graphics to enhance readability and accessibility of the educational content. The investigators enhanced the platform to enable an interactive goal-setting functionality for participants to set health goals paced with participants' Learning Activities and calls. The online program is maintained and monitored by the study's health coach managers.

• Health behavior tracking (diet and exercise). Participants will receive specific skill-building on how to track diet and exercise behaviors via mainstream mobile app or paper/pencil, using procedures from the investigators' current trial. Coaches will be able to discuss tracking data with participants. Mainstream tracking apps are available in both Spanish and English.

• Weekly self-weighing. Participants will be asked to weigh themselves weekly at home using the participants' study scale. ;

Related Conditions & MeSH terms

• Behavior, Health
• Body Weight
• Gestational Weight Gain
• Overweight
• Overweight and Obesity
• Postpartum Weight Retention
• Pregnancy Weight Gain
• Weight Gain

• NCT number: NCT05619705
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Kelly M Bower, PhD, MSN/MPH
• Phone: 410-955-4280
• Email: kbower1@jhu.edu
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Completion date: August 31, 2025