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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    432
  • sponsor
    Pennington Biomedical Research Center
Updated on 19 June 2022
Accepts healthy volunteers

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.

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).

Details
Condition Weight Gain During Pregnancy
Treatment Healthy Beginnings
Clinical Study IdentifierNCT04028843
SponsorPennington Biomedical Research Center
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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