Behavior, Health, Overweight and Obesity, Postpartum Weight Retention, Pregnancy Weight Gain
Conditions
Keywords
Behavioral Intervention, Early Childhood Home Visiting, Overweight, Obesity, Postpartum, Pregnancy
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 participants. The overall goal is to improve long-term 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.
Interventions
BEHAVIORALHealthy for Two-Health Coaching (H42)
The H42-HV intervention includes health coaching calls, H42 web based app, mobile phone-based tracking.
BEHAVIORALMaintain Healthy in Pregnancy and Postpartum(mHIPP)
A brief video on maternal warning signs that is available in English or Spanish.
Sponsors
Johns Hopkins University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postpartum weight (retention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in gestational weight (gain) | 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. |
| Change in maternal diet as assessed by the Dietary Screener Questionnaire (DSQ) | 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. |
| Change in maternal physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) | 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). |
| Maternal smoking habits as assessed by the Center for Disease Control and Prevention Pregnancy Risk Assessment Monitoring System (CDC PRAMS) | Baseline | A four-item portion of the PRAMS survey will be utilized to determine cigarette use before and during pregnancy. |
| Change in breastfeeding Practice as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS) | 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. |
| Breastfeeding Intention as assessed by the Center for Disease Control and Prevention Infant Feeding Practices Survey (CDC IFPS) | 37 weeks gestation | A two-item portion of the CDC IFPS will be used to assess breastfeeding intention. |
| Change in maternal depression as assessed by the Edinburgh Postpartum Depression scale | 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. |
| Change in maternal sleep habits as assessed by the Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Change in maternal social support as assessed by the Functional Social Support Questionnaire (FSSQ) | 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. |
| Maternal healthcare utilization as assessed by Medicaid data extraction | Up to 6 months after delivery | Postpartum OBGYN visit and primary care provider visit by six months. |
| Infant healthcare utilization as assessed by Medicaid data extraction | Up to 6 months after delivery | Well-child visit appointments through six months of life. |
Countries
United States
Contacts
CONTACTKelly M Bower, PhD, MSN/MPH
CONTACTWendy Bennett, MD,MPH
PRINCIPAL_INVESTIGATORKelly Bower, PhD, MSN/MPH
Johns Hopkins School of Nursing
PRINCIPAL_INVESTIGATORWendy Bennett, MD,MPH
Johns Hopkins School of Medicine
Outcome results
None listed