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

Johns Hopkins University

Status: Enrolling

Conditions: Pregnancy Weight Gain; Overweight and Obesity; Postpartum Weight Retention; Behavior, Health

Treatments: Behavioral: Maintain Healthy in Pregnancy and Postpartum(mHIPP); Behavioral: Healthy for Two-Health Coaching (H42)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05619705

1P50MD017348-01 (U.S. NIH Grant/Contract)

IRB00307430

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant, ≤33 weeks gestation
• Singleton pregnancy
• Pre pregnancy BMI≥25.0 Kg/m^2 (calculated based on self-reported pre pregnancy height and weight)
• Able to provide informed consent
• English or Spanish speaking
• Enrolled in participating home visiting program
• Completion of screening and baseline data collection
• Willing to participate in the intervention and data collection procedure (e.g., home weights)

Exclusion criteria

• Type 1 diabetes or taking insulin prior to delivery
• > 33 weeks gestation
• Pregnant with multiple fetuses
• Unable to walk 1 block without pain or shortness of breath
• Not cleared by the study's clinicians or home visiting program staff
• Planning to relocate from area during next 1 year
• Active substance abuse disorder (except marijuana)
• Psychiatric or substance use related hospitalization in past 1 year
• Active eating disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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360 participants in 2 patient groups

Healthy for Two-Health Coaching (H42)

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy for Two-Health Coaching (H42)

Maintain Health in Pregnancy and Postpartum (mHIPP)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Maintain Healthy in Pregnancy and Postpartum(mHIPP)