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Clinical Trials/NCT03382132
NCT03382132
Completed
N/A

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

University of Kansas Medical Center1 site in 1 country78 target enrollmentSeptember 20, 2017
ConditionsHealth Behavior

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Behavior
Sponsor
University of Kansas Medical Center
Enrollment
78
Locations
1
Primary Endpoint
Minutes of moderate to vigorous physical activity per week
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2017
End Date
August 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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.

Study Sites (1)

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