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momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology

momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03382132
Acronym
momHealth
Enrollment
78
Registered
2017-12-22
Start date
2017-09-20
Completion date
2020-08-30
Last updated
2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Behavior

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.

Interventions

BEHAVIORALmomHealth

Mobile health program delivered via an iPad. Program delivers information and support related to breastfeeding education, Ten Steps of the Baby Friendly Hospital Initiative, healthy eating and active living topics, and depression prevention information.

BEHAVIORALStandard of Care

Participants will receive standard health care via their prenatal provider, including routine prenatal education and postpartum support.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 20 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Duration of breastfeedingMonth 3Number of days out to 3 months postpartum of any breastfeeding.
Consumption of red foods per dayChange from Baseline to Month 3Measure 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.
Minutes of moderate to vigorous physical activity per weekChange from Baseline to Month 3Measure will be assessed using ActiGraph Physical Activity Monitors.
Change in depressive symptomsMonth 3Assessed 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.
Rate of any and exclusive breastfeedingMonth 3Self-report data on breastfeeding continuation, either wholly or partially, out to 3 months postpartum.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026