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A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy (SmartMomsinWIC)

Primary Purpose

Weight Gain During Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Beginnings
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain During Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Less than 16 weeks gestational age at screening visit
  • Have a BMI of 18.5 to 40 kg/m2
  • Expecting a singleton pregnancy
  • Certified to receive Women, Infants, and Children services during current pregnancy
  • Has smartphone with internet access
  • Willing to be identifiable to other study participants in this study program

Exclusion Criteria:

  • Smoking
  • Drug or alcohol use
  • Non-pregnancy related illness
  • Hypertension at screening visit
  • Current mental health issue or eating disorder
  • Inability to complete a behavioral run-in task
  • Plans to move out of the state in the next 18 months

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

WIC Nutrition

Healthy Beginnings

Arm Description

Participants will receive weight management advice and care through the standard Women, Infants, and Children program. They will also receive weekly health information related to pregnancy, birth, and infant health through a closed Facebook group.

Participants will receive the SmartMoms smartphone application, a wireless connected scale, and a Fitbit. The Healthy Beginnings program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the SmartMoms smartphone application, personalized feedback from counselors, and evidence-based behavioral intervention delivered throughout pregnancy.

Outcomes

Primary Outcome Measures

Number of Women Who Have Excess Gestational Weight Gain
Number of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines

Secondary Outcome Measures

Total Gestational Weight Gain
Gestational Weight Gain Per Week
"per week" is included to adjust for the different length of time between weight measurements

Full Information

First Posted
July 19, 2019
Last Updated
August 29, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
Louisiana Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT04028843
Brief Title
A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
Acronym
SmartMomsinWIC
Official Title
SmartMoms in WIC: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Louisiana Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.
Detailed Description
The study is a multi-site randomized controlled trial, testing the effectiveness of the smartphone-based behavior modification program in pregnant women within the Louisiana Women, Infants, and Children program. Equal number of participants will be randomized to either the intervention or the control. Although the intervention itself lasts 24 weeks (only during pregnancy), women will be enrolled in this study for approximately 18 months, from the 10-16th week of pregnancy until 12 month postpartum follow-up. Study outcomes will be assessed at three visits during pregnancy (early, mid, and late,) and three visits postpartum (1, 6, and 12 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain During Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assigned stratified by maternal BMI and site
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WIC Nutrition
Arm Type
No Intervention
Arm Description
Participants will receive weight management advice and care through the standard Women, Infants, and Children program. They will also receive weekly health information related to pregnancy, birth, and infant health through a closed Facebook group.
Arm Title
Healthy Beginnings
Arm Type
Experimental
Arm Description
Participants will receive the SmartMoms smartphone application, a wireless connected scale, and a Fitbit. The Healthy Beginnings program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the SmartMoms smartphone application, personalized feedback from counselors, and evidence-based behavioral intervention delivered throughout pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Beginnings
Intervention Description
The program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the smartphone application, personalized feedback from counselors and, evidence-based behavioral intervention delivered throughout pregnancy.
Primary Outcome Measure Information:
Title
Number of Women Who Have Excess Gestational Weight Gain
Description
Number of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines
Time Frame
Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Secondary Outcome Measure Information:
Title
Total Gestational Weight Gain
Time Frame
Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Title
Gestational Weight Gain Per Week
Description
"per week" is included to adjust for the different length of time between weight measurements
Time Frame
Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Less than 16 weeks gestational age at screening visit Have a BMI of 18.5 to 40 kg/m2 Expecting a singleton pregnancy Certified to receive Women, Infants, and Children services during current pregnancy Has smartphone with internet access Willing to be identifiable to other study participants in this study program Exclusion Criteria: Smoking Drug or alcohol use Non-pregnancy related illness Hypertension at screening visit Current mental health issue or eating disorder Inability to complete a behavioral run-in task Plans to move out of the state in the next 18 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abby D Altazan, M.S.
Phone
225-763-2801
Email
Abby.Altazan@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne M Redman, Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby D Altazan, M.S.
Email
Abby.Altazan@pbrc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual data can be shared with appropriate material/data use agreements but there are no current plans.
Citations:
PubMed Identifier
32909954
Citation
Flanagan EW, Altazan AD, Comardelle NR, Gilmore LA, Apolzan JW, St Romain J, Hardee JC, Puyau RS, Mayet CL, Beyl RA, Barlow SA, Bounds SS, Olson KN, Kennedy BM, Hsia DS, Redman LM. The Design of a Randomized Clinical Trial to Evaluate a Pragmatic and Scalable eHealth Intervention for the Management of Gestational Weight Gain in Low-Income Women: Protocol for the SmartMoms in WIC Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e18211. doi: 10.2196/18211.
Results Reference
derived

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A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy

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