Johns Hopkins School of Nursing
Baltimore, Maryland, 21205, United States
Location status: Recruiting
NCT Number: NCT05619705
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Baltimore, Maryland, 21205, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
A brief video on maternal warning signs that is available in English or Spanish.
Other names: "Usual Home Visiting Plus"
Time frame: Baseline and 6 months postpartum
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 immediately before delivery
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, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
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 postpartum
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
A four-item portion of the PRAMS survey will be utilized to determine cigarette use before and during pregnancy.
Time frame: 2 months postpartum, 4 months postpartum, 6 months postpartum
A 4-item portion of the CDC IFPS will be used at 2,4, and 6 months postpartum to assess current breastfeeding practice.
Time frame: 37 weeks gestation
A two-item portion of the CDC IFPS will be used to assess breastfeeding intention.
Time frame: Baseline, 37 weeks gestation, 2 months postpartum, 4 months postpartum, 6 months postpartum
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.
Time frame: Baseline, 2 months postpartum, 4 months postpartum, 6 months postpartum
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.
Time frame: Baseline, 36-38 weeks prenatal, 2 months postpartum, 4 months postpartum, 6 months postpartum
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.
Time frame: Up to 6 months after delivery
Postpartum OBGYN visit and primary care provider visit by six months.
Time frame: Up to 6 months after delivery
Well-child visit appointments through six months of life.
Contact information is provided by the study sponsor or research team.
Kelly M Bower, PhD, MSN/MPH
CONTACT
Wendy Bennett, MD,MPH
CONTACT
Johns Hopkins University
Other
Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04724330
Body Weight, Body Weight Changes
Baltimore, Maryland, United States
View Trial DetailsNCT06491537
Behavior, Body Weight
Birmingham, Alabama, United States
View Trial DetailsNCT04449432
Body Weight, Body Weight Changes
Davis, California, United States
View Trial DetailsNCT05579990
Body Weight, Body Weight Changes
Birmingham, Alabama, United States
View Trial Details