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

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ClinicalTrials.gov Identifier: NCT03382132
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: momHealth Behavioral: Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Experimental: momHealth
Participants will receive support and information via the momHealth program.
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.

Active Comparator: Control
Participants will receive the normal support they would normally receive if they were not in a study.
Behavioral: Standard of Care
Participants will receive standard health care via their prenatal provider, including routine prenatal education and postpartum support.




Primary Outcome Measures :
  1. Duration of breastfeeding [ Time Frame: Month 3 ]
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382132


Contacts
Contact: Melissa Lopez 913-588-7162 mlopez4@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Karen Wambach, PhD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03382132     History of Changes
Other Study ID Numbers: STUDY00141254
R21HD088913-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No