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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Weight Gain During Pregnancy

Intervention / Treatment
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* Behavioral: Healthy Beginnings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assigned stratified by maternal BMI and site
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: WIC Nutrition<br>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. | |
| Experimental: Healthy Beginnings<br>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. | Behavioral: Healthy Beginnings<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women Who Have Excess Gestational Weight Gain | Number of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Gestational Weight Gain |  | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) | 
| Gestational Weight Gain Per Week | per week is included to adjust for the different length of time between weight measurements | Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) |