Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for low-income pregnant women in Louisiana who are less than 16 weeks along, expecting one baby, and enrolled in the WIC program. Participants must have a BMI between 18.5 to 40 kg/m2, own a smartphone with internet, and be willing to share their identity with others in the study. Women who smoke or use drugs/alcohol, have hypertension or mental health issues/eating disorders, or plan to move out of state soon cannot join.Inclusion Criteria
I am less than 16 weeks pregnant.
Exclusion Criteria
I am currently dealing with a mental health issue or eating disorder.
Treatment Details
The 'Healthy Beginnings' program uses smartphones to help pregnant women eat better and maintain healthy weight gain. This statewide study randomly assigns participants into two groups: one using the app and another without it (control group), comparing outcomes like nutrition and pregnancy weight gain.
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy BeginningsExperimental Treatment1 Intervention
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.
Group II: WIC NutritionActive Control1 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Pennington Biomedical Research CenterBaton Rouge, LA
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Who is running the clinical trial?
Pennington Biomedical Research CenterLead Sponsor
Louisiana Department of HealthCollaborator