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

NCT ID: NCT03382132

Last Updated: 2020-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2020-08-30

Brief Summary

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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

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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.

Conditions

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Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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momHealth

Participants will receive support and information via the momHealth program.

Group Type EXPERIMENTAL

momHealth

Intervention Type 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.

Control

Participants will receive the normal support they would normally receive if they were not in a study.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Standard of Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Wambach, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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R21HD088913-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00141254

Identifier Type: -

Identifier Source: org_study_id

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