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

Not Applicable

Active, not recruiting

• Conditions: Weight Gain During Pregnancy
• Interventions: Behavioral: Healthy Beginnings

• Registration Number: NCT04028843
• Lead Sponsor: Pennington Biomedical Research Center

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).

Study Timeline

• Study Start: 2019-07-12
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-23
• Primary Completion: 2024-05-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Beginnings	Healthy Beginnings	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.

Primary Outcome Measures

Name	Time	Method
Number of Women Who Have Appropriate Gestational Weight Gain	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 Outcome Measures

Name	Time	Method
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)	"per week" is included to adjust for the different length of time between weight measurements

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States