Digital Intervention for Obesity

(DIRECTION Trial)

Overseen By Teresita Gormaz, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Metabolism drugs

Disqualifiers: Cancer, Heart disease, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program called My Viva Plan, designed to help people with obesity improve their lifestyle. It examines how a web-based wellness platform affects weight, diet, exercise, stress, sleep, and alcohol use. Participants will either use the platform independently or with support from healthcare professionals through weekly video sessions. Suitable candidates include Alberta residents with a Body Mass Index (BMI) of 30-35, interested in weight loss, and able to participate in video sessions. As an unphased trial, this study offers a unique opportunity to explore a new wellness approach and contribute to understanding its impact on lifestyle changes.

Will I have to stop taking my current medications?

The trial requires that participants not take any medication or supplements that may affect energy metabolism, body weight, or composition. You may need to stop certain medications, but this will be evaluated by the study investigators.

What prior data suggests that this digital intervention is safe for managing obesity?

Research shows that My Viva Plan is generally easy to use. In a previous program called CHANGE, participants using My Viva Plan experienced positive health outcomes, including a 30.8% improvement in metabolic syndrome. This syndrome consists of conditions that increase the risk of heart disease, stroke, and diabetes. No major reports of negative effects have emerged from using My Viva Plan, suggesting its safety. The plan emphasizes healthy eating, exercise, and mindfulness, all known to benefit overall health.

The platform engages users by utilizing real-time health data to customize the plan to individual needs. This personalized approach aims to enhance safety and effectiveness. As a digital wellness tool, My Viva Plan does not carry the same risk of side effects as medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional obesity treatments that often rely on medications or invasive procedures, the My Viva Plan is unique because it combines digital technology with expert support. Researchers are excited about this approach because it offers a web-based wellness platform that integrates nutrition, physical activity, and mindfulness, providing a holistic method of tackling obesity. The standout feature is the combination of self-guided online resources with weekly group video sessions facilitated by healthcare professionals, such as registered dietitians, mental health therapists, and exercise experts. This dual approach not only empowers individuals to take control of their health at their own pace but also provides them with professional support and community interaction, which can enhance motivation and accountability.

What evidence suggests that this digital intervention is effective for obesity?

Research has shown that My Viva Plan, one of the treatments in this trial, can improve weight and overall health when combined with professional support. Participants in this trial may access this online program, which includes weekly group video conferencing sessions led by healthcare professionals. One study found that this approach helped users enhance their body shape and eating habits. It emphasizes healthy lifestyle changes, crucial for reducing the risk of heart disease, stroke, and Type 2 diabetes. Users have reported feeling less stressed and having better eating habits with support from healthcare professionals. This suggests that online tools, paired with expert guidance, can effectively manage excess body weight. ^{3 4 6 7 8}

Who Is on the Research Team?

Carla Prado, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for Albertans aged 40-65 with a BMI of 30-35, seeking weight loss and able to exercise safely. Participants must have internet-capable cell phones, speak English, and be available for video calls on evenings/weekends. They should not have significant medical conditions or history of bariatric surgery.

Inclusion Criteria

Able to speak, read and understand English

Able to safely exercise as screened by the 2022 Physical Activity Readiness Questionnaire (PAR-Q+)

I am between 40 and 65 years old.

Exclusion Criteria

Participating in intensive lifestyle interventions, structured exercise programming (> 3hrs of vigorous physical activity per week) or structured diet programming

I have untreated mood disorders or eating disorders.

I am not on medications or supplements that affect my metabolism or body weight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a web-based wellness platform for 16 weeks, with one group receiving additional weekly group video conferencing sessions with healthcare professionals

16 weeks

Weekly group video conferencing sessions for the intervention arm

Follow-up

Participants are monitored for changes in body weight, diet quality, physical activity, stress, sleep, and alcohol use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• My Viva Plan

Trial Overview The study compares two groups: one using a web-based self-care platform (active control) and the other adding professional health guidance to the same platform (intervention arm). Both groups will wear Fitbits and participate for 16 weeks.

How Is the Trial Designed?

Group I: Web-based wellness platform with healthcare professional-facilitated online support Experimental Treatment 2 Interventions

Participants will receive access to a web-based wellness platform focused on nutrition, physical activity, and mindfulness. In addition to the platform access, participants will take part in weekly group video conferencing sessions with various healthcare professionals (registered dietitian, mental health therapist, and exercise professional). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.

Group II: Web-based wellness platform Active Control 1 Intervention

Participants will receive access to a web-based wellness platform focused on nutrition, physical activity, and mindfulness. Interactions with the platform will be fully self-guided (without weekly group video conferencing sessions healthcare professionals and peers).

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1. discover.myvivaplan.com discover.myvivaplan.com/research/

Research, Science Behind MVP | My Viva Inc. We also know that at least 80% of all heart disease, stroke and Type 2 diabetes and over 40% of cancers could be prevented through adopting healthier lifestyle ...

2. researchgate.net researchgate.net/figure/Effects-of-My-Viva-Plan-on-Body-Composition-and-Diet-Quality_tbl3_375011802

Effects of My Viva Plan on Body Composition and Diet Quality A Randomized Controlled Trial of the Effects of a Web-Based Intervention on Perceived Stress and Diet Quality Among First-Year University Students. Article.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6143399/

Two-Year Results of Think Health! ¡Vive Saludable! Think Health! ¡Vive Saludable! evaluated a moderate-intensity lifestyle behavioral weight loss program in primary care over 2 years of treatment.

4. discover.myvivaplan.com discover.myvivaplan.com/in_the_news/duly-health-and-care-integrates-my-viva-plan-to-empower-patients-living-with-obesity/?utm_campaign=Global%20Briefings&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz--rx2gAlh8lXiH6rE4UHWK3YeHTIxUf5qUEgI-Wc6A4yV_hLqe2DxCzEJB2y2q9pIhHxktO

Duly Health and Care Integrates My Viva Plan® to Empower ... It educates patients on mental wellness, nutrition, and physical activity while adjusting plans automatically based on individual progress.

5. discover.myvivaplan.com discover.myvivaplan.com/for-patients/

Healthy Lifestyle Take Control of Your Health | My Viva Inc. Here are some case studies and outcomes from users of My Viva Plan®. Diabetes Prevention. Diabetes. Read More.

6. myvivaplan.com myvivaplan.com/landing/images/MVP-proven-results-3.pdf

Proven Results - My Viva Plan Patients received My Viva Plan during the initial 3 months of the CHANGE program which resulted in a. 30.8% MetS reversal rate. In 2023, the BMC Musculoskeletal ...

7. discover.myvivaplan.com discover.myvivaplan.com/in_the_news/my-viva-integrates-health-data-technology-to-enhance-patient-engagement-and-personalized-care/

My Viva Integrates Health Data Technology to Enhance ... This partnership aims to enhance patient engagement and optimize care delivery by integrating real-time health data monitoring into My Viva Plan.

8. vida.com vida.com/thought-leadership/clinical-obesity-management-outcomes/

Clinical Obesity Management Outcomes This infographic highlights the measurable success of Vida's personalized, cost-effective approach to obesity care.