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

Health Behavior Clinical Trial

— momHealth  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382132
• Other study ID #: STUDY00141254
• Secondary ID: R21HD088913-01A1
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: September 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 30, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• momHealth
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.
• Standard of Care
Participants will receive standard health care via their prenatal provider, including routine prenatal education and postpartum support.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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