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Completed

NCT Number: NCT04028843

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

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.

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Key information

Conditions

Weight Gain During Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Women Who Have Appropriate Gestational Weight Gain

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

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

Secondary outcomes

  1. Total Gestational Weight Gain

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

    Measured weight from 10-16 weeks gestation to 35-38 weeks gestation

  2. Gestational Weight Gain Per Week

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

    Weight measured from 10-16 weeks gestation to 35-38 weeks gestation divided by the number of weeks between measures.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Louisiana Department of Health
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Acronym: SmartMomsinWIC

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jul 23, 2019
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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