Clinical trial NCT03382132: momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology
Official title: momHealth: Multiple Health Behavior Change Intervention in Teen Pregnancy & Parenting Using Mobile Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-12-22
Enrollment: 78
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration of breastfeeding
timeFrame: Month 3
measure: Consumption of "red" foods per day
timeFrame: Change from Baseline to Month 3
measure: Minutes of moderate to vigorous physical activity per week
timeFrame: Change from Baseline to Month 3
measure: Change in depressive symptoms
timeFrame: Month 3
measure: Rate of any and exclusive breastfeeding
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Karen Wambach, PhD
role: PRINCIPAL_INVESTIGATOR
References: