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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619705
• Other study ID #: IRB00307430
• Secondary ID: 1P50MD017348-01
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: Kelly M Bower, PhD, MSN/MPH
• Phone: 410-955-4280
• Email: kbower1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Healthy for Two-Health Coaching (H42)
The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
• Maintain Healthy in Pregnancy and Postpartum(mHIPP)
A brief video on maternal warning signs that is available in English or Spanish.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postpartum weight (retention)	Difference between pre-pregnancy weight and weight at 6 months postpartum. Pre-pregnancy weight (baseline) will be self-reported and then confirmed by prenatal clinic medical records. 6 month postpartum weight will be obtained via BodyTrace study scales provided to all participants.	Baseline and 6 months postpartum
Secondary	Change in gestational weight (gain)	Difference between pre-pregnancy weight and delivery weight. Pre-pregnancy weight will be self-reported and then confirmed by prenatal clinic records. Delivery weight will be obtained via BodyTrace study scales provided to each participant.	Baseline and immediately before delivery
Secondary	Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ)	Dietary intake will be assessed using the NHANES 2009-10 Dietary Screener Questionnaire (DSQ) Eating Habits Questionnaire (28-items). Scoring equations exist to estimate daily intake of fruits/vegetables, dairy, added sugars, whole grains, and calcium.	Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
Secondary	Change in maternal physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)	The Short Form International Physical Activity Questionnaire contains 9 items to collect data on health-related physical activity in the past seven days. Physical activity is categorized as high (at least one hour of moderate intensity exercise daily), moderate (approximately 30 minutes of moderate intensity exercise most days), or low (not meeting the criteria of high or moderate exercise).	Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
Secondary	Maternal smoking habits as assessed by the Center for Disease Control and Prevention Pregnancy Risk Assessment Monitoring System (CDC PRAMS)	A four-item portion of the PRAMS survey will be utilized to determine cigarette use before and during pregnancy.	Baseline
Secondary	Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)	A 4-item portion of the CDC IFPS will be used at 2,4, and 6 months postpartum to assess current breastfeeding practice.	2 months postpartum, 4 months postpartum, 6 months postpartum
Secondary	Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS)	A two-item portion of the CDC IFPS will be used to assess breastfeeding intention.	37 weeks gestation
Secondary	Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale	The Edinburgh Postpartum Depression scale is a 10-item measure assessing changes in mood over the past seven days. The last question related to suicidal ideation has been removed. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.	Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
Secondary	Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a 19-item questionnaire assessing sleep habits in the past seven days. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score (0-21) and higher scores indicate worse sleep quality.	Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum
Secondary	Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ)	The FSSQ is an 8-item measure that evaluates confidant support and affective support. Responses are scored 1-5 and an average is calculated based on the response from all eight items. A higher score indicates greater perceived social support.	Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum
Secondary	Maternal healthcare utilization as assessed by Medicaid data extraction	Postpartum OBGYN visit and primary care provider visit by six months.	Up to 6 months after delivery
Secondary	Infant healthcare utilization as assessed by Medicaid data extraction	Well-child visit appointments through six months of life.	Up to 6 months after delivery