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Digital Intervention for Obesity (DIRECTION Trial)

N/A

Recruiting

Led By Carla Prado, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 16.

Awards & highlights

DIRECTION Trial Summary

This trial will assess the impact of health professional guidance on weight loss in overweight Albertans.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a digital intervention focusing on lifestyle changes rather than medication, side effects are minimal but may include discomfort from wearing a Fitbit or stress from adapting to new diet/exercise routines.

DIRECTION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 16.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 16.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 16. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in body weight.

Secondary outcome measures

Change in diet quality.

Change in measured step counts.

Change in physical activity.

+4 more

DIRECTION Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Web-based wellness platform with healthcare professional-facilitated online supportExperimental Treatment2 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 platformActive Control1 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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

384,958 Total Patients Enrolled

18 Trials studying Obesity

11,383 Patients Enrolled for Obesity

Carla Prado, PhDPrincipal InvestigatorUniversity of Alberta

8 Previous Clinical Trials

441 Total Patients Enrolled

1 Trials studying Obesity

50 Patients Enrolled for Obesity

Media Library

My Viva Plan Clinical Trial Eligibility Overview. Trial Name: NCT05579704 — N/A

Obesity Research Study Groups: Web-based wellness platform with healthcare professional-facilitated online support, Web-based wellness platform

Obesity Clinical Trial 2023: My Viva Plan Highlights & Side Effects. Trial Name: NCT05579704 — N/A

My Viva Plan 2023 Treatment Timeline for Medical Study. Trial Name: NCT05579704 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cutoff age for this trial 45 years or older?

"The target demographic for this study are individuals aged 40 and older, but younger than 65."

Answered by AI

Are there any current opportunities for individuals to take part in this investigation?

"Affirmative, the information listed on clinicaltrials.gov shows that this research is actively recruiting volunteers. Initially posted in December of 2022 and last edited around the same time, 180 people are required to take part at one medical facility."

Answered by AI

What is the current number of participants for this clinical trial?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is currently recruiting participants; the post was first issued on December 15th 2022, and recently revised that same day. A total of 180 people are being sought at a single location for this study."

Answered by AI

Does this clinical trial offer the opportunity for me to join?

"This research trial is seeking 180 obese individuals, aged 40 to 65 years old. The applicant must demonstrate linguistic fluency, be open to video conferencing during evening and weekend-time slots, consent to wear a Fitbit activity monitor for 16 weeks, possess Alberta residency with obesity (BMI 30-35 kg/m2), show an intent of weight loss through the S-Weight Questionnaire screening process; pass the 2022 Physical Activity Readiness Questionnaire (PAR-Q+); have access to cell phone service with internet and Bluetooth capabilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Intervention for Behaviour Change and Chronic Disease Prevention

Carla Prado 2022. "Digital Intervention for Behaviour Change and Chronic Disease Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05579704.