Smartphone App for Healthy Pregnancy Weight Management

(SmartMomsinWIC Trial)

Overseen By Abby D Altazan, M.S.

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Smoking, Drug use, Alcohol use, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app can help pregnant women manage their weight healthily. It features a program called Healthy Beginnings, which uses a smartphone app, a connected scale, and a Fitbit to track and encourage healthy weight gain during pregnancy. The app provides participants with feedback and personalized advice from counselors. Women who are less than 16 weeks pregnant, have a BMI between 18.5 and 40, are expecting one baby, and are enrolled in the Women, Infants, and Children program in Louisiana may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance pregnancy health management for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this smartphone app is safe for healthy pregnancy weight management?

Research shows that the Healthy Beginnings program, which uses the SmartMoms smartphone app, helps manage weight during pregnancy. The app provides weekly tips to support healthy weight gain and habits. Studies on similar programs, like SmartMoms, indicate they are generally easy for users to handle.

Participants in past studies did not report major problems related to the app. The program focuses on tracking weight and activity, with feedback from the app and counselors. This method supports healthy habits without direct medical treatment. Since the program uses a smartphone app, along with tools like a Fitbit and scale, it remains non-invasive and safe for most people.

In summary, evidence so far suggests that the Healthy Beginnings program is safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Beginnings program because it offers a fresh approach to managing pregnancy weight gain through the use of technology. Unlike traditional methods that rely on in-person consultations and generalized advice, this program leverages a smartphone app, a connected scale, and a Fitbit to provide personalized, real-time feedback on weight and activity levels. The automated and personalized feedback, combined with evidence-based behavioral interventions, empowers pregnant women to self-monitor and adjust their behaviors for healthier outcomes. This high-tech, personalized approach aims to make managing gestational weight gain more proactive and effective than ever before.

What evidence suggests that the Healthy Beginnings program might be an effective treatment for healthy pregnancy weight management?

Research shows that the Healthy Beginnings program, available through the SmartMoms smartphone app, may help expectant mothers gain a healthy amount of weight during pregnancy. Participants in this trial will receive the SmartMoms app, which provides personalized feedback and helps users track their weight and activity, supporting healthier lifestyle choices. Studies have found that similar apps can reduce excessive weight gain by encouraging better eating and exercise habits. Early results suggest that this technology effectively guides pregnant women in maintaining a healthy weight. These positive findings highlight the app's potential to support healthier pregnancies. ^{2 3 6 7 8}

Who Is on the Research Team?

Leanne M Redman, Ph.D.

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to be identifiable to other study participants in this study program

Expecting a singleton pregnancy

I am less than 16 weeks pregnant.

Exclusion Criteria

Inability to complete a behavioral run-in task

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

Smoking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 24-week intensive behavior modification program using the SmartMoms smartphone application, a wireless connected scale, and a Fitbit. The program targets healthy gestational weight gain through self-monitoring, automated feedback, and personalized counseling.

24 weeks

3 visits during pregnancy (early, mid, and late)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 6, and 12 months postpartum.

12 months

3 visits postpartum (1, 6, and 12 months)

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Beginnings

Trial Overview

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.

How Is the Trial Designed?

Group I: Healthy Beginnings Experimental Treatment 1 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 Nutrition Active Control 1 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.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Louisiana Department of Health

Collaborator

Trials

1

Recruited

350+

Published Research Related to This Trial

A study involving 64 pregnant women showed that 86% were interested in using a website or mobile app to manage healthy weight gain during pregnancy, indicating a strong demand for digital health tools in this area.

The findings suggest that online interventions could effectively help prevent excessive weight gain during pregnancy, which is important for the health of both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnant women's interest in a website or mobile application for healthy gestational weight gain. Waring, ME., Moore Simas, TA., Xiao, RS., et al.[2018]

Overweight and obese pregnant women expressed a strong desire to safely manage their weight gain during pregnancy, highlighting their need for support and effective tools, such as mHealth apps, to help them achieve their goals.

Participants reported positive experiences with mHealth apps, which facilitated healthier eating and physical activity, potentially increasing their self-efficacy and adherence to weight management strategies to prevent excessive gestational weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Help me fight my constant battle": A focus group study of overweight and obese women's mHealth app experiences to manage gestational weight gain. Lee, CF., Hsiung, Y., Chi, LK., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33704075/

Effectiveness of a Smartphone App to Promote Healthy ...

Our results demonstrate the potential of a smartphone app (HealthyMoms) to promote healthy dietary behaviors as well as to decrease weight gain during ...

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mhealth.jmir.org

mhealth.jmir.org/2017/9/e133/

Effectiveness of SmartMoms, a Novel eHealth Intervention for ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03298555

The HealthyMoms Trial to Promote Healthy Gestational ...

The objectives of this study are to assess whether a 6-month smartphone application can promote healthy gestational weight gain, dietary habits and physical ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714422003925

SmartMoms Canada: An evaluation of a mobile app ...

SmartMoms Canada is the first bilingual Canadian-centric app designed for pregnant people. This mHealth intervention, with its ability to supply frequent ...

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researchprotocols.org

researchprotocols.org/2020/9/e18211/

Protocol for the SmartMoms in WIC Trial

The Healthy Beginnings intervention is a 24-week intensive behavior modification program now customized for pregnant women receiving WIC that ...

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pmc.ncbi.nlm.nih.gov/articles/PMC10806627/

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SmartMom provides evidence-based information timed to be relevant to each week of pregnancy. The overall goal of SmartMom is to motivate the ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0031938422002839

The short-term effect of a mHealth intervention on ...

The present study aimed to assess the short-term effect of the SmartMoms Canada app to promote adequate GWG and healthy behaviors.

8.

isrctn.com

isrctn.com/ISRCTN16254958

SmartMoms Canada: An evaluation of a pregnancy ...

Gestational weight collected at minimum once per week by the app will be tracked in personalized graphs and used to provide an associated caloric equivalent ...