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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2025-05-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Personalized Management of Body Weight During Pregnancy

NCT01610752

Weight Gain During Pregnancy

COMPLETED NA

Study of a Randomized Intervention Designed to Increase Exercise in Pregnancy

NCT03936283

Gestational Weight Gain

COMPLETED NA

A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

NCT03880461

Gestational Weight Gain

COMPLETED NA

Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics

NCT06116149

Obesity Gestational Diabetes Lifestyle, Healthy +3 more

RECRUITING NA

Promoting Appropriate Weight Gain Pregnant Women

NCT04180878

Pregnancy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Weight Gain During Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assigned stratified by maternal BMI and site

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WIC Nutrition

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy Beginnings

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 Type EXPERIMENTAL

Healthy Beginnings

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes