momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology (momHealth)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03382132|
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : July 13, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Participants will receive support and information via the momHealth program.
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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Melissa Lopezemail@example.com|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Karen Wambach, PhD||University of Kansas Medical Center|