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Completed

NCT Number: NCT03382132

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

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.

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Key information

Conditions

Health Behavior Behavior

Age range

15 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

momHealth

Behavioral

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

Behavioral

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

Primary outcomes

  1. Duration of breastfeeding

    Time frame: Month 3

    Number of days out to 3 months postpartum of any breastfeeding.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: momHealth

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2017
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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