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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SmartMomsinWIC Trial 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.Check my eligibility

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.See study design

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.

SmartMomsinWIC Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am less than 16 weeks pregnant.

SmartMomsinWIC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Women Who Have Excess Gestational Weight Gain

Secondary outcome measures

Gestational Weight Gain Per Week

Total Gestational Weight Gain

SmartMomsinWIC 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

304 Previous Clinical Trials

181,085 Total Patients Enrolled

1 Trials studying Weight Gain During Pregnancy

54 Patients Enrolled for Weight Gain During Pregnancy

Louisiana Department of HealthUNKNOWN

Leanne M Redman, Ph.D.Principal InvestigatorPennington Biomedical Research Center

8 Previous Clinical Trials

1,370 Total Patients Enrolled

1 Trials studying Weight Gain During Pregnancy

54 Patients Enrolled for Weight Gain During Pregnancy

Media Library

Healthy Beginnings (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04028843 — N/A

Weight Gain During Pregnancy Research Study Groups: WIC Nutrition, Healthy Beginnings

Weight Gain During Pregnancy Clinical Trial 2023: Healthy Beginnings Highlights & Side Effects. Trial Name: NCT04028843 — N/A

Healthy Beginnings (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04028843 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment presently seeking participants?

"Per the information on clinicaltrials.gov, this research study is actively enrolling participants. It was first published on July 12th 2019 and was last modified September 26th 2022."

Answered by AI

What is the upper limit for participants in this experiment?

"Affirmative. According to the information given on clinicaltrials.gov, this medical study - which was first posted on July 12th 2019- is currently seeking participants. As of now, 432 patients are needed from 1 distinct health facility."

Answered by AI

Does the research team have any age-based restrictions for participants?

"According to the eligibility requirements of this research, only people between 18 and 40 years old can participate. For those below 18 or above 65, there are 46 and 93 trials respectively that they may be able to join."

Answered by AI

Are there any specific criteria that participants must meet in order to qualify for this trial?

"This research study is seeking 432 individuals, aged between 18 and 40 years old, who are currently obese. Other requirements for possible enrolment include possessing a smartphone with internet access; having had less than 16 weeks of gestation at the time of screening; BMI scores falling within the range from 18.5 to 40 kg/m2; expecting singleton pregnancies only; being certified as eligible to receive Women Infants and Children services during their pregnancy period; and consenting to be identifiable by other participants in this trial programme."

Answered by AI