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Behavioral Intervention

Smartphone App for Healthy Pregnancy Weight Management (SmartMomsinWIC Trial)

N/A

Waitlist Available

Led By Leanne M Redman, Ph.D.

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 16 weeks gestational age at screening visit

Be between 18 and 65 years old

Must not have

Current mental health issue or eating disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a smartphone app to help low-income women enrolled in the WIC program improve their health.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves behavior modification through an app rather than medication or medical procedures, traditional side effects are not expected; however, there may be indirect effects related to changes in diet or stress from participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am less than 16 weeks pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently dealing with a mental health issue or eating disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Women Who Have Appropriate Gestational Weight Gain

Secondary study objectives

Gestational Weight Gain Per Week

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met