Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJohns Hopkins University
About this trial
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 participants. The overall goal is to improve long-term cardiometabolic health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant, ≤33 weeks gestation
Singleton pregnancy
Pre pregnancy BMI≥25.0 Kg/m² (calculated based on self-reported pre pregnancy height and weight)
Able to provide informed consent
Disqualifiers
Type 1 diabetes or taking insulin prior to delivery
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
Trial design
Design model
Single group
Treatments tested in this trial
Healthy for Two-Health Coaching (H42)
BehavioralThe H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
Maintain Healthy in Pregnancy and Postpartum(mHIPP)
BehavioralA brief video on maternal warning signs that is available in English or Spanish.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Healthy for Two-Health Coaching (H42)Experimental treatment 1 intervention
Group B: Maintain Health in Pregnancy and Postpartum (mHIPP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 months postpartumSecondary outcomes
1
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.
Time frame
Baseline and immediately before delivery2
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.
Time frame
Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum3
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).
Time frame
Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum4
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.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov