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

186 Participants Needed

Trial Summary

What is the purpose of this trial?

Body weight, diet quality, physical activity, stress, sleep and alcohol use will be evaluated in a sample of 180 Albertans with excess body weight. Participants will be randomized into the following two groups; active control arm (access to a preventative self-care web-based platform for 16 weeks) vs. intervention arm (access to a preventative self-care web-based platform for 16 weeks plus health professional guidance and supervision).

Research Team

Carla Prado, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+