momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Minutes of moderate to vigorous physical activity per week
Study Overview
Brief Summary
The purpose of this study is to find out if information and support provided with a mobile-delivered (via iPad) momHealth Teen Pregnancy Program can promote healthy choices and behaviors during and after pregnancy.
Detailed Description
This is a RCT to pilot test an innovative multiple health behavior intervention to influence three areas of health for pregnant and parenting adolescents: breastfeeding, healthy eating/active living, and depression prevention. Intervention and control groups will be compared in the main outcomes of the study (see 4.2.c. and 4.3). Beginning in the last eight weeks of pregnancy and extending to one month after giving birth, we use mobile health technology (e.g., iPad minis) to deliver multi-media educational modules, text-messaging, virtual home visits with professionals using secure televideo, and real-time peer group support over televideo. At birth, five weeks, and three months after giving birth, effectiveness of the program outcomes will be assessed and compared to a usual care control group and include breastfeeding/infant-feeding practices; healthy eating and physical activity; and depressive symptoms. This is the first known study to address these multiple behaviors simultaneously with pregnant and parenting adolescent women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 20 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant females
- •English-speaking
- •Giving birth to first child
- •Intending to keep the newborn
- •Access to a telephone
- •27-31 weeks gestation
- •Low-risk pregnancy
Exclusion Criteria
- •Multiple gestation pregnancy
- •High-risk pregnancy
- •Women with active untreated mental health conditions such as affective disorder, substance use disorder, anxiety disorder (excluding simple phobia), or psychosis
Arms & Interventions
Control
Participants will receive the normal support they would normally receive if they were not in a study.
Intervention: Standard of Care (Behavioral)
momHealth
Participants will receive support and information via the momHealth program.
Intervention: momHealth (Behavioral)
Outcomes
Primary Outcomes
Minutes of moderate to vigorous physical activity per week
Time Frame: Change from Baseline to Month 3
Measure will be assessed using ActiGraph Physical Activity Monitors.
Rate of any and exclusive breastfeeding
Time Frame: Month 3
Self-report data on breastfeeding continuation, either wholly or partially, out to 3 months postpartum.
Duration of breastfeeding
Time Frame: Month 3
Number of days out to 3 months postpartum of any breastfeeding.
Consumption of "red" foods per day
Time Frame: Change from Baseline to Month 3
Measure will be assessed using the Automated Self-Administered 24-hour Recall™ (ASA24™). Participants will provide information on food eaten through an online site and accessed with an individualized link.
Change in depressive symptoms
Time Frame: Month 3
Assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item questionnaire. Each question response is coded from 0 to 3. Scores can range from a minimum of 0 to a maximum of 30. A score of 10 or greater detects a major depressive disorder with sensitivity.
Secondary Outcomes
No secondary outcomes reported