Back to resultsPreventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
Primary Purpose
Gestational Weight Gain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition and physical activity intervention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Weight Gain
Eligibility Criteria
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
Sites / Locations
- University of Hawaii
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Nutrition and physical activity intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Change between pre-pregnancy weight and last weight taken before delivery
Total weight gained during pregnancy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04330976
Brief Title
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
Official Title
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
June 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hawaii
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Weight Gain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition and physical activity intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and physical activity intervention
Intervention Description
Messages sent on nutrition and physical activity in pregnancy
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Messages sent on general health during pregnancy
Primary Outcome Measure Information:
Title
Change between pre-pregnancy weight and last weight taken before delivery
Description
Total weight gained during pregnancy
Time Frame
From date of randomization until delivery of child (e.g. up to 25 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96822
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preventing Excessive Gestational Weight Gain Via Short Mobile Messages in WIC
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