NCT01461707

Brief Summary

Obesity among women of childbearing age and excessive weight gain during pregnancy are prevalent and steadily increasing health care issues. Regular physical activity is recommended to maintain healthy weight gain for pregnant women, however, a majority of pregnant women are sedentary. The investigators proposed to conduct a pilot study to estimate the potential efficacy of a mobile phone based physical activity intervention in 30 physically inactive pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 5, 2017

Completed
Last Updated

November 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

October 26, 2011

Results QC Date

March 24, 2017

Last Update Submit

October 24, 2017

Conditions

Physical Activity

Keywords

Cellular phoneexercisepregnant womenobesityoverweightphysical activity

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Monitor Measured Steps

    Change in weekly mean steps per day

    12 weeks

Secondary Outcomes (1)

  • 7-Day Physical Activity Recall

    12 weeks

Study Arms (2)

Mobile app plus activity monitor group

EXPERIMENTAL

Participants in the group will receive the mobile phone-based physical activity program and an activity monitor

Behavioral: Mobile phone-based physical activityBehavioral: Activity monitor

Activity monitor group

ACTIVE COMPARATOR

Participants in the group will receive an activity monitor

Behavioral: Activity monitor

Interventions

Mobile phone-based physical activityBEHAVIORAL

Participants will receive the mobile phone-based physical activity program using the trial app.

Mobile app plus activity monitor group
Activity monitorBEHAVIORAL

Participants will receive an activity monitor

Activity monitor groupMobile app plus activity monitor group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnant, gestational week (10-20 weeks)
  • pre-pregnancy BMI ≥ 18.5 kg•m2
  • physically inactive at work and during leisure time
  • intent to be physically active
  • access to a home telephone or a mobile phone
  • have a personal computer access
  • ability to communicate (speak and read) in English.

You may not qualify if:

  • known medical or obstetric complication that restricts physical activity
  • history of eating disorders
  • current participation in lifestyle modification programs
  • history of bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (1)

  • Choi J, Lee JH, Vittinghoff E, Fukuoka Y. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women. Matern Child Health J. 2016 May;20(5):1091-101. doi: 10.1007/s10995-015-1895-7.

    PMID: 26649879DERIVED

MeSH Terms

Conditions

Motor ActivityObesityOverweight

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

BehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Results Point of Contact

Title
JiWon Choi
Organization
University of California, San Francisco
jiwon.choi@ucsf.edu
415-514-2534

Study Officials

  • JiWon Choi, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

November 30, 2017

Results First Posted

May 5, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)