NCT03382132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

December 13, 2017

Last Update Submit

September 1, 2020

Conditions

Health Behavior

Outcome Measures

Primary Outcomes (5)

  • Duration of breastfeeding

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

    Month 3

  • Consumption of "red" foods per day

    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.

    Change from Baseline to Month 3

  • Minutes of moderate to vigorous physical activity per week

    Measure will be assessed using ActiGraph Physical Activity Monitors.

    Change from Baseline to Month 3

  • Change in depressive symptoms

    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.

    Month 3

  • Rate of any and exclusive breastfeeding

    Self-report data on breastfeeding continuation, either wholly or partially, out to 3 months postpartum.

    Month 3

Study Arms (2)

momHealth

EXPERIMENTAL

Participants will receive support and information via the momHealth program.

Behavioral: momHealth

Control

ACTIVE COMPARATOR

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

Behavioral: Standard of Care

Interventions

momHealthBEHAVIORAL

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.

momHealth
Standard of CareBEHAVIORAL

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

Control

Eligibility Criteria

Age15 Years - 20 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant females
  • English-speaking
  • Giving birth to first child
  • Intending to keep the newborn
  • Access to a telephone
  • weeks gestation
  • Low-risk pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Karen Wambach, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 22, 2017

Study Start

September 20, 2017

Primary Completion

May 25, 2020

Study Completion

August 30, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

US(1)