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

Pennington Biomedical Research Center

Status: Active, not recruiting

Conditions: Weight Gain During Pregnancy

Treatments: Behavioral: Healthy Beginnings

Study type: Interventional

Funder types: Other

Identifiers

NCT04028843

PBRC 2018-039

Details and patient eligibility

About

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.

Full 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).

Enrollment: 351 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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351 participants in 2 patient groups

WIC Nutrition

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Healthy Beginnings