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

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Behavioral: Standard of Care; Behavioral: momHealth

• Registration Number: NCT03382132
• Lead Sponsor: University of Kansas Medical Center

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 Timeline

• Study Start: 2017-09-20
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-22
• Primary Completion: 2020-05-25
• Study Completion: 2020-08-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard of Care	Participants will receive the normal support they would normally receive if they were not in a study.
momHealth	momHealth	Participants will receive support and information via the momHealth program.

Primary Outcome Measures

Name	Time	Method
Minutes of moderate to vigorous physical activity per week	Change from Baseline to Month 3	Measure will be assessed using ActiGraph Physical Activity Monitors.
Rate of any and exclusive breastfeeding	Month 3	Self-report data on breastfeeding continuation, either wholly or partially, out to 3 months postpartum.
Duration of breastfeeding	Month 3	Number of days out to 3 months postpartum of any breastfeeding.
Consumption of "red" foods per day	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	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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States