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CompletedNCT03382132momHealthUpdated Sep 3, 2020

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

An interventional study of momHealth and Standard of Care in Health Behavior, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to female participants aged 15 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
15 Years to 20 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 421 studies in Health Behavior with a site in United States — 66 open to participants now, 86 under way, 1 of them phase 3. Health Behavior · United States.

Enrollment
240th of 385
78 · median 130
Started
2017
with 24 others
No phase
363 of 421
58 open now
Registered
149th of 421
by date

Among the 421 studies in Health Behavior with a site in United States, this one is the 240th largest by enrollment of the 385 interventional ones that give a count, is one of 25 that started in 2017, is one of 363 with no phase, and was the 149th registered.

Health Behavior

968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.

Browse Health Behavior studies →

Open to participants now

66 of the 421 studies in Health Behavior with a site in United States are open now. Recruiting first, the newest first:

61 more — sign in →

All 66 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.

This study: 15 Years to 20 Years · female · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Health Behavior

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04

Who can participate

Ages eligible
15 Years to 20 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    momHealth

    Participants will receive support and information via the momHealth program.

    Behavioral: momHealth

  • Active comparator
    Control

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

    Behavioral: Standard of Care

Interventions

  • BehavioralmomHealth

    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.

  • BehavioralStandard of Care

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

06

What researchers measure

Primary outcomes

  1. Duration of breastfeeding

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

    Time frame: Month 3

  2. 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.

    Time frame: Change from Baseline to Month 3

  3. Minutes of moderate to vigorous physical activity per week

    Measure will be assessed using ActiGraph Physical Activity Monitors.

    Time frame: Change from Baseline to Month 3

  4. 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.

    Time frame: Month 3

  5. Rate of any and exclusive breastfeeding

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

    Time frame: Month 3

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in May 2020, 32 months.

Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 32 months is above that.

Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2017
First posted
Dec 22, 2017
StartActual
Sep 20, 2017
Primary completionActual
May 25, 2020
CompletionActual
Aug 30, 2020
Last update
Sep 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03382132
Responsible party
Sponsor
First posted
Dec 22, 2017
Start date
Sep 20, 2017
Primary completion
May 25, 2020
Completion
Aug 30, 2020
Last update
Sep 3, 2020

Study contacts

Karen Wambach, PhD
principal investigator · University of Kansas Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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