My Health Coach App for Fetal Alcohol Spectrum Disorders

Overseen By Christie L. M. Petrenko, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Past trial participation

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartphone app, the My Health Coach App, can help adults with fetal alcohol spectrum disorders (FASD) improve their quality of life and manage daily tasks more effectively. Participants will either begin using the app immediately or after 12 weeks, allowing researchers to compare their experiences. Eligible participants must be adults with FASD or a history of prenatal alcohol exposure, fluent in English, and own a smartphone. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance daily living for those with FASD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the My Health Coach app is safe for adults with FASD?

Research has shown that adults with fetal alcohol spectrum disorders (FASD) generally like the My Health Coach app. Although specific safety information for this app is not available, studies have not identified any negative effects. Testing has assessed its effectiveness, and it seems helpful for adults in managing their condition. As a mobile app, it likely poses no physical safety risks. Overall, it appears to be a safe and supportive tool for people with FASD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Fetal Alcohol Spectrum Disorders (FASD) focus on managing symptoms through therapies and medications. However, the My Health Coach App is unique because it delivers support through a mobile health intervention tailored specifically for adults with FASD. This app uses a just-in-time adaptive intervention design, which means it offers personalized support exactly when users need it most. Additionally, it employs a simple and engaging chatbot interface, making it accessible and user-friendly. Researchers are excited about this approach as it integrates well-established behavior change strategies with self-determination theory, potentially offering a more effective and empowering way for individuals with FASD to manage their condition.

What evidence suggests that the My Health Coach app is effective for improving the quality of life in adults with fetal alcohol spectrum disorders?

Research shows that the My Health Coach app, which participants in this trial may receive, can help adults with fetal alcohol spectrum disorders (FASD) manage their condition. The app provides support precisely when needed. Previous studies found the app practical and helpful for adults with FASD. Community members have shared positive feedback, noting that the app could improve their quality of life. While more research is needed, these early findings suggest the app could be a useful tool for handling daily challenges related to FASD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with fetal alcohol spectrum disorders (FASD) or a history of prenatal alcohol exposure. Participants must be fluent in English and own a smartphone. It's not specified who can't join, but typically those with conditions affecting participation would be excluded.

Inclusion Criteria

I have been diagnosed with FASD or was exposed to alcohol before birth.

I can read and write in English well.

I own a smartphone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete the initial set of surveys to assess baseline measures

1 week

1 visit (virtual)

Treatment

Participants in the My Health Coach group use the app, while the waitlist group does not receive the app

12 weeks

2 visits (virtual) at 6 and 12 weeks

Follow-up

Participants are monitored for changes in quality of life and day-to-day functioning

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• My Health Coach App

Trial Overview The My Health Coach app is being tested to see if it improves quality of life and daily management for adults with FASD. The study involves completing surveys at the start, after 6 weeks, and after 12 weeks. Some get the app immediately; others wait until after the final survey for comparison.

How Is the Trial Designed?

Group I: My Health Coach App Group Experimental Treatment 1 Intervention

The My Health Coach group receives the My Health Coach app at study start. The My Health Coach app is a self-directed mobile health intervention for adults with FASD. It is grounded in self-determination theory and integrates well-established behavior change strategies. It has a cloud-based infrastructure and uses a just-in-time adaptive intervention design and a simple and engaging chatbot interface. It provides adults just the right type and amount of support, when they are most receptive.

Group II: Waitlist Control Group Active Control 1 Intervention

The Waitlist Control Group gets access to the My Health Coach app after all the study survey timepoints are complete at 12 weeks.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Published Research Related to This Trial

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

The 'Quest' app, designed for relapse prevention in patients with alcohol dependence syndrome, received high usability (5.8 out of 7) and acceptability (65%) ratings from users, indicating it is user-friendly and well-received.

While both groups (those using the Quest app and those receiving standard treatment) showed a significant reduction in drinking days over three months, there was no notable difference in relapse rates or heavy drinking days between the two groups, suggesting the app's effectiveness needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. Sharma, AK., Shadakshari, D., Chand, P., et al.[2023]

This study aims to evaluate the effectiveness of a technology-delivered Screening and Brief Intervention (SBI) for pregnant women with unhealthy alcohol use, using a factorial design to assess various intervention strategies.

The primary goal is to measure alcohol abstinence in participants, with secondary outcomes including the impact of tailored text messages and the intervention's effects on birth outcomes, ensuring a comprehensive approach to addressing prenatal alcohol exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol. Ondersma, SJ., Todd, L., Jablonski, S., et al.[2023]

A systematic evaluation of seven DASH diet apps revealed that only two apps, NOOM and DASH To TEN, met both quality and data security standards, making them suitable for supporting self-management of the DASH diet.

While three apps scored high in quality across various domains, most apps exhibited significant shortcomings in quality and data privacy, highlighting the need for better app development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of the Most Suitable Mobile Apps to Support Dietary Approaches to Stop Hypertension (DASH) Diet Self-Management: Systematic Search of App Stores and Content Analysis. Alnooh, G., Alessa, T., Noorwali, E., et al.[2023]

The interactive, video-enhanced e-SBI (electronic screening and brief intervention) was found to be highly acceptable among pregnant women, with participants rating it as easy to use and helpful, scoring between 4.7 to 5.0 on a 5-point scale.

The pilot trial suggested medium-sized effects of the e-SBI on achieving 90-day period prevalence abstinence from alcohol and improved pregnancy outcomes, with odds ratios of 3.4 and 3.3 respectively, indicating potential benefits that warrant further investigation in a larger study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial. Ondersma, SJ., Beatty, JR., Svikis, DS., et al.[2018]

In a pilot study involving 36 pregnant adolescents, the use of wrist-worn accelerometers to assess physical activity was found to be neither feasible nor acceptable, with only 51.5% achieving the minimum of 4 days of valid wear.

Participants rated the acceptability of accelerometer use as neutral, suggesting that future research should explore better incentives and possibly lower wear-time requirements to improve adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Accelerometer Measurement of Physical Activity in Pregnant Adolescents. Clark, ELM., Gulley, LD., Hilkin, AM., et al.[2022]

A review of 370 smartphone apps for child nutrition identified 33 that qualified for analysis, revealing that many lack updated information and do not cite their sources, which raises concerns about the reliability of the guidance provided to parents.

Only a small number of apps offer expert consultations or specific nutrient requirements, indicating a lack of uniform guidelines in the development of these applications, which could affect their effectiveness in supporting child nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. Srivastava, R., Kushwaha, S., Khanna, P., et al.[2022]

A scoping review of 16 studies found that pregnancy-specific apps often lack transparency and credibility regarding the information they provide, which raises safety concerns for users.

Key safety considerations identified include the need for better protection of personal data, the importance of evidence-based content, and the necessity for apps to be tailored to local guidelines and users' digital health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. Carrandi, A., Hayman, M., Harrison, CL.[2023]

A systematic review of 27 studies found that health and fitness apps can lead to significant improvements in diet, physical activity, and sedentary behavior, particularly in adults, with 17 out of 23 adult-targeted studies showing positive health outcomes.

Multi-component interventions that include apps were more effective than stand-alone app interventions, suggesting that combining app features with other strategies may enhance user engagement and health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions that use apps to improve diet, physical activity and sedentary behaviour: a systematic review. Schoeppe, S., Alley, S., Van Lippevelde, W., et al.[2022]

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11179453/

My Health Coach: Community members' perspectives on a ... My Health Coach is a just-in-time adaptive intervention (JITAI) for adults with FASD. JITAIs aim to provide the right type and amount of support ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05604014

Feasibility Study of the My Health Coach App for Adults ... The purpose of this study is to test a new smartphone "app" for adults with fetal alcohol spectrum disorder (FASD). The app is called My Health Coach. The goal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0891422225001374

Feasibility trial of the My Health Coach app for adults ... Conclusions. The My Health Coach app is feasible and shows promise in supporting adults with FASD with condition management. Trial results prove sufficient to ...

4. withpower.com withpower.com/trial/my-health-coach-app-for-fetal-alcohol-spectrum-disorders-5010a

My Health Coach App for Fetal Alcohol Spectrum Disorders The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol ...

5. psych.rochester.edu psych.rochester.edu/MHFC/research/current-studies/fetal-alcohol-spectrum-disorders-research-studies/

Fetal Alcohol Spectrum Disorders Research Studies A randomized control trial testing the effectiveness of the My Health Coach app is expected to begin in early 2025. The study will test whether the app ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40450957/

Feasibility trial of the My Health Coach app for adults with fetal ... Conclusions: The My Health Coach app is feasible and shows promise in supporting adults with FASD with condition management. Trial results prove ...

7. fasdcollaborative.com fasdcollaborative.com/research

FASD Research Recruitment Man Trying App. My Health Coach App Study. Target group: Adults with FASD worldwide. Targeting adults with an FASD, ages 18 and over, from any country worldwide.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT05604014/Prot_SAP_000.pdf

NCT05604014 Feasibility Study of the My Health Coach ... The project aims to develop a mobile health (mHealth) application. (app) for adults with fetal alcohol spectrum disorders (FASD). In the ...