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Digital Intervention for Behaviour Change and Chronic Disease Prevention (DIRECTION)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
My Viva Plan (www.myvivaplan.com)
Online support group with health professionals
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Albertans with excess body weight (BMI 30-35 kg/m2)
  • Individuals who are seeking weight loss as screened by the S-Weight Questionnaire
  • Ages 40-65 years of age, any sex/gender
  • Able to safely exercise as screened by the 2022 Physical Activity Readiness Questionnaire (PAR-Q+)
  • Must have a cell phone with internet access and Bluetooth capabilities
  • Able to participate in video conferencing on evenings and/or weekends
  • Willing to wear a Fitbit activity monitor on the wrist for 16 weeks.
  • Able to speak, read and understand English

Exclusion Criteria:

  • Participating in intensive lifestyle interventions, structured exercise programming (> 3hrs of vigorous physical activity per week) or structured diet programming
  • Taking any medication or supplements that may alter energy metabolism, body weight and composition, as evaluated by study investigators;
  • Chronic conditions in which weight loss is not indicated or controversial. Significant medical self-reported comorbidities, including uncontrolled metabolic disorders (e.g., cancer, thyroid, stroke, kidney, liver, respiratory, heart disease, type 1 or uncontrolled type 2 diabetes)
  • Self-reported eating disorders, untreated depression, anxiety or other mood disorders
  • Weight loss greater than 25 lbs (11 kg) in the past 6 months
  • Previous bariatric surgery
  • Presence of a pacemaker or implantable cardioverter defibrillator
  • Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs)
  • Unable to adhere to the study protocol

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

My Viva Plan Access

My Viva Plan Access with Health Professional Support

Arm Description

Participants will receive access to a web-based platform called My Viva Plan® (MVP, www.myvivaplan.com). Interactions with the platform will be fully self-guided (without weekly group video conferencing sessions health professionals).

Participants will receive access to a web-based platform called My Viva Plan® (MVP, www.myvivaplan.com). In addition to MVP access, participants will take part in weekly group video conferencing sessions with various health professionals (registered dietitian, psychologist, and exercise specialist). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.

Outcomes

Primary Outcome Measures

Change in body weight.
Body weight changes will be measured using Bluetooth enabled smart scales (Fitbit Aria scale) for daily tracking of body weight.

Secondary Outcome Measures

Change in diet quality.
Diet quality changes will be assessed using the Canadian version of the Healthy Eating Index (HEI) measured using the Automated Self-Administered 24-h Dietary Assessment Tool (ASA 24).
Change in self-reported physical activity.
Self-reported physical activity will be assessed using the Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTEQ). Scored as a range from 0 to 24+, where <14 indicates sedentary, 14-23 indicates moderately active and >24 indicates active.
Change in measured step counts.
Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track step counts.
Change in physical activity.
Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track active minutes.
Change in self-reported stress.
Self-reported stress will be assessed using the Perceived Stress Scale (PSS). Scored as a range from 0 to 40, where <14 indicates low stress, 14-26 indicates moderate stress and >26 indicates high perceived stress.
Change in self-reported sleep quality.
Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Scored as a range from 0 to 21, where a higher score indicates worse sleep quality.
Change in self-reported alcohol use.
Self-reported alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT). Scored as a range from 0 to 40, where a score of 0 indicates an abstainer, a score of 1-7 suggests low-risk consumption, a scores of 8-14 suggest hazardous consumption and a score >15 indicates the likelihood of alcohol dependence.

Full Information

First Posted
October 3, 2022
Last Updated
September 22, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05579704
Brief Title
Digital Intervention for Behaviour Change and Chronic Disease Prevention
Acronym
DIRECTION
Official Title
Digital Intervention for Behaviour Change and Chronic Disease Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
Excess body weight, poor diet, physical inactivity, alcohol consumption, stress, and sleep deprivation/disruption are modifiable risk factors associated with chronic diseases, such as cancer. While most Canadians may be aware that these play a role in chronic disease prevention, individualized tools are needed to foster sustainable, long-term habits. Digital health solutions have become commonplace in self-care. They offer an opportunity to reach a large number of individuals with personalized programs to improve health and lower the risk of developing chronic disease. Many digital applications are available for individuals to monitor their diet, activity and weight; however, few have been validated and are based on scientific evidence. Recently, a Canadian web-based platform centered on preventive self-care became available. This platform was created by health care professionals and encompasses three key pillars of health: nutrition, physical activity, and mindfulness. The effectiveness of this web-based wellness platform will be evaluated in people living with excess body weight to improve six chronic disease risk factors: body weight, diet quality, physical activity, alcohol intake, stress, and sleep habits. A fully self-guided approach (active control, Arm 1) will be compared to an approach guided by a healthcare professional (Arm 2) and compare risk factors pre- and post-intervention. Investigators hypothesize that both approaches will improve modifiable risk factors, but participants guided by a healthcare professional will have greater improvements. Qualitatively, the experiences of immigrants using the platform will be explored. Participants will use the web-based platform for 16 weeks. Our primary outcome is 5% weight loss, which has been shown to reduce chronic disease incidence. Secondary outcomes include improvements in overall diet quality, physical activity and sleep quality, and decrease in alcohol intake and stress. To assess the primary and one of the secondary outcomes (physical activity), a smart scale and a wearable device will be used. Wearable devices are widely used and an effective approach to body weight reduction. Additionally, immigrants' experiences and perspectives of participating in this study will be explored using semi-structured interviews.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
My Viva Plan Access
Arm Type
Active Comparator
Arm Description
Participants will receive access to a web-based platform called My Viva Plan® (MVP, www.myvivaplan.com). Interactions with the platform will be fully self-guided (without weekly group video conferencing sessions health professionals).
Arm Title
My Viva Plan Access with Health Professional Support
Arm Type
Experimental
Arm Description
Participants will receive access to a web-based platform called My Viva Plan® (MVP, www.myvivaplan.com). In addition to MVP access, participants will take part in weekly group video conferencing sessions with various health professionals (registered dietitian, psychologist, and exercise specialist). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.
Intervention Type
Behavioral
Intervention Name(s)
My Viva Plan (www.myvivaplan.com)
Intervention Description
A web-based platform is based on preventive self-care and contains tools to monitor nutrition, physical activity, and mental wellbeing.
Intervention Type
Behavioral
Intervention Name(s)
Online support group with health professionals
Intervention Description
Participants will take part in weekly group video conferencing sessions with various health professionals (registered dietitian, psychologist, and exercise specialist). The sessions will occur once per week for 1 hour each. The group sessions will contain cohorts of approximately 10 individuals.
Primary Outcome Measure Information:
Title
Change in body weight.
Description
Body weight changes will be measured using Bluetooth enabled smart scales (Fitbit Aria scale) for daily tracking of body weight.
Time Frame
Baseline to Week 16.
Secondary Outcome Measure Information:
Title
Change in diet quality.
Description
Diet quality changes will be assessed using the Canadian version of the Healthy Eating Index (HEI) measured using the Automated Self-Administered 24-h Dietary Assessment Tool (ASA 24).
Time Frame
Baseline to Week 16.
Title
Change in self-reported physical activity.
Description
Self-reported physical activity will be assessed using the Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTEQ). Scored as a range from 0 to 24+, where <14 indicates sedentary, 14-23 indicates moderately active and >24 indicates active.
Time Frame
Baseline to Week 16.
Title
Change in measured step counts.
Description
Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track step counts.
Time Frame
Baseline to Week 16.
Title
Change in physical activity.
Description
Physical activity changes will be measured using a wrist-worn wearable activity monitor (Fitbit Inspire 2) to track active minutes.
Time Frame
Baseline to Week 16.
Title
Change in self-reported stress.
Description
Self-reported stress will be assessed using the Perceived Stress Scale (PSS). Scored as a range from 0 to 40, where <14 indicates low stress, 14-26 indicates moderate stress and >26 indicates high perceived stress.
Time Frame
Baseline to Week 16.
Title
Change in self-reported sleep quality.
Description
Self-reported sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Scored as a range from 0 to 21, where a higher score indicates worse sleep quality.
Time Frame
Baseline to Week 16.
Title
Change in self-reported alcohol use.
Description
Self-reported alcohol use will be assessed using the Alcohol Use Disorders Identification Test (AUDIT). Scored as a range from 0 to 40, where a score of 0 indicates an abstainer, a score of 1-7 suggests low-risk consumption, a scores of 8-14 suggest hazardous consumption and a score >15 indicates the likelihood of alcohol dependence.
Time Frame
Baseline to Week 16.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Albertans with excess body weight (BMI 30-35 kg/m2) Individuals who are seeking weight loss as screened by the S-Weight Questionnaire Ages 40-65 years of age, any sex/gender Able to safely exercise as screened by the 2022 Physical Activity Readiness Questionnaire (PAR-Q+) Must have a cell phone with internet access and Bluetooth capabilities Able to participate in video conferencing on evenings and/or weekends Willing to wear a Fitbit activity monitor on the wrist for 16 weeks. Able to speak, read and understand English Exclusion Criteria: Participating in intensive lifestyle interventions, structured exercise programming (> 3hrs of vigorous physical activity per week) or structured diet programming Taking any medication or supplements that may alter energy metabolism, body weight and composition, as evaluated by study investigators; Chronic conditions in which weight loss is not indicated or controversial. Significant medical self-reported comorbidities, including uncontrolled metabolic disorders (e.g., cancer, thyroid, stroke, kidney, liver, respiratory, heart disease, type 1 or uncontrolled type 2 diabetes) Self-reported eating disorders, untreated depression, anxiety or other mood disorders Weight loss greater than 25 lbs (11 kg) in the past 6 months Previous bariatric surgery Active substance abuse (alcohol, cannabis, illicit drugs, prescription drugs) Unable to adhere to the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresita Gormaz, MSc
Phone
780-492-780
Email
gormazre@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carla Prado, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresita Gormaz, MSc
Phone
(780) 492-7820
Email
gormazre@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Intervention for Behaviour Change and Chronic Disease Prevention

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