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

Weight Gain During Pregnancy Clinical Trial

— SmartMomsinWIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04028843
• Other study ID #: PBRC 2018-039
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 351
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Gain
• Weight Gain During Pregnancy

Intervention

Behavioral:
• Healthy Beginnings
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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Louisiana Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Gestational Weight Gain		Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Secondary	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)