- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330976
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
March 31, 2020 updated by: University of Hawaii
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
The objective of this trial was to investigate the effect of educational short message service (SMS), or text messages, on gestational weight gain (GWG) in a low-income population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96822
- University of Hawaii
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 15-20 weeks gestational age and 18 years of age or older at time of recruitment
- body mass index (BMI) of 25-45 kg/m2 in the first trimester
- possession of a cellular phone with the ability to receive text messages without a charge
Exclusion Criteria:
- conditions requiring a special diet
- multiparous pregnancies
- unable to consent to participate
- unwilling to be randomized
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Control
|
Messages sent on general health during pregnancy
|
EXPERIMENTAL: Nutrition and physical activity intervention
|
Messages sent on nutrition and physical activity in pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change between pre-pregnancy weight and last weight taken before delivery
Time Frame: From date of randomization until delivery of child (e.g. up to 25 weeks)
|
Total weight gained during pregnancy
|
From date of randomization until delivery of child (e.g. up to 25 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 30, 2017
Primary Completion (ACTUAL)
October 29, 2018
Study Completion (ACTUAL)
June 2, 2019
Study Registration Dates
First Submitted
February 28, 2020
First Submitted That Met QC Criteria
March 31, 2020
First Posted (ACTUAL)
April 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 2, 2020
Last Update Submitted That Met QC Criteria
March 31, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5U54MD008149-09 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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