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

NCT04028843 | Completed Results

• 2 other identifiers: PBRC 2018-039R01NR017644
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Gain During Pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of Women Who Have Appropriate Gestational Weight Gain

  Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines

  Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Secondary Outcomes (2)

• Total Gestational Weight Gain

  Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

• Gestational Weight Gain Per Week

  Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Study Arms (2)

WIC Nutrition

NO INTERVENTION

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.

Healthy Beginnings

EXPERIMENTAL

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.

Behavioral: Healthy Beginnings

Interventions

Healthy Beginnings BEHAVIORAL

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.

Healthy Beginnings

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Louisiana Department of Health: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (4)

• Kracht CL, Falkenhain K, Flanagan EW, Altazan AD, Cabre HE, Kebbe M, Woolf EK, Beyl R, Hsia DS, Apolzan JW, Redman L. Effect of a Pragmatic eHealth Behavioral Gestational Weight Gain Intervention on Household Chaos in Pregnant People of Lower Socioeconomic Status: Randomized Controlled Trial. JMIR Ment Health. 2026 Jan 8;13:e74146. doi: 10.2196/74146.

  PMID: 41505178 DERIVED

• Cabre HE, Falkenhain K, Altazan AD, Flanagan EW, Kracht CL, Sparks JR, Kebbe M, Woolf EK, Hsia DS, Gilmore LA, Beyl R, Apolzan JW, Redman LM. Examining the Impact of a Codeveloped Multicomponent Mobile eHealth Lifestyle Intervention on Physical Activity and Its Association With Gestational Weight Gain in Underserved Women: A Statewide Randomized Controlled Trial. J Med Internet Res. 2025 Nov 11;27:e73962. doi: 10.2196/73962.

  PMID: 41218199 DERIVED

• Kebbe M, Falkenhain K, Beyl R, Altazan AD, Flanagan EW, Kracht CL, Cabre HE, Woolf EK, Hsia DS, Apolzan JW, Redman LM. An eHealth Intervention in Pregnancy on Maternal Body Composition and Subsequent Perinatal Outcomes: A Randomized Trial. Obesity (Silver Spring). 2025 Sep;33(9):1680-1693. doi: 10.1002/oby.24357. Epub 2025 Jul 24.

  PMID: 40707419 DERIVED

• 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.

  PMID: 32909954 DERIVED

Results Point of Contact

• Title: Dr. Leanne Redman
• Organization: Pennington Biomedical Research Center

Leanne.Redman@pbrc.edu

2257630947

Study Officials

• Leanne M Redman, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel assigned stratified by maternal BMI and site

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: July 12, 2019
• Primary Completion: May 21, 2024
• Study Completion: May 29, 2025
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)