Clinical trial NCT05619705: Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women
Official title: Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Weight Retention
Pregnancy Weight Gain
Overweight and Obesity
Behavior, Health
Keywords: Behavioral Intervention
Early Childhood Home Visiting
Overweight
Obesity
Postpartum
Pregnancy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-11-17
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The design of the study is a randomized, two parallel-arm clinical trial. The investigators will be applying principles of a hybrid type 1 effectiveness-implementation randomized control trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in postpartum weight (retention)
timeFrame: Baseline and 6 months postpartum
Secondary outcomes:
measure: Change in gestational weight (gain)
timeFrame: Baseline and immediately before delivery
measure: Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ)
timeFrame: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
measure: Change in maternal physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
measure: Maternal smoking habits as assessed by the Center for Disease Control and Prevention Pregnancy Risk Assessment Monitoring System (CDC PRAMS)
timeFrame: Baseline
measure: Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)
timeFrame: 2 months postpartum, 4 months postpartum, 6 months postpartum
measure: Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)
timeFrame: 37 weeks gestation
measure: Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale
timeFrame: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
measure: Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum
measure: Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ)
timeFrame: Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum
measure: Maternal healthcare utilization as assessed by Medicaid data extraction
timeFrame: Up to 6 months after delivery
measure: Infant healthcare utilization as assessed by Medicaid data extraction
timeFrame: Up to 6 months after delivery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Kelly Bower, PhD, MSN/MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins School of Medicine
name: Wendy Bennett, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: