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

Pennington Biomedical Research Center351 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

351

Conditions

Weight Gain During Pregnancy

Interventions

Healthy BeginningsBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Outcomes

Primary Outcomes

Number of Women Who Have Appropriate Gestational Weight Gain

Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines

Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Secondary Outcomes

Total Gestational Weight Gain

Measured weight from 10-16 weeks gestation to 35-38 weeks gestation

Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Gestational Weight Gain Per Week

Weight measured from 10-16 weeks gestation to 35-38 weeks gestation divided by the number of weeks between measures.

Time frame: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)

Data from ClinicalTrials.gov

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