NCT04784624

Brief Summary

This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

February 8, 2021

Last Update Submit

April 21, 2022

Conditions

Keywords

virtual platformevaluationdietphysical activitybehavior changesleepstress

Outcome Measures

Primary Outcomes (2)

  • Impact of COVID-19 survey

    A COVID-19 wellbeing survey will be used to understand the impact of COVID-19 pandemic on lifestyle behaviours and programs and services have changed in response to COVID-19

    Start of the program - first week of enrollment

  • Program adherence

    Participants will be qualified as adhering to the program if they attend a minimum of 3 out of 4 health coaching sessions and have at least 1 activity during weeks 12-18.

    16 weeks

Secondary Outcomes (25)

  • Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)

    16 weeks

  • Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S)

    16 weeks

  • Dietary intake

    16 weeks

  • Dietary behavior

    16 weeks

  • Dietary habits

    16 weeks

  • +20 more secondary outcomes

Interventions

The cardiometabolic and weight loss program is based on The Wellness Institute clinically validated lifestyle medicine program and will be delivered virtually using a digital platform and artificial intelligence that is supported by a health coach. The program focuses on building individual's self-efficacy, motivation and importance to make and sustain healthy choices. The 16-week program begins with a health risk assessment and a personalized wellness plan. The plan includes a personalized exercise plan and nutrition strategy. Each user will regularly check-in with their personal health coach whose role is to provide expert advice and also empower, support and help make the user accountable as they build a healthy lifestyle. Coaching includes identifying obstacles to changing behaviors and how to develop new behaviors that will become the norm.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from individuals enrolled in the online program and willing and able to give informed consent for participation in the evaluation

You may qualify if:

  • Male or female, aged 18 years or above, have one or more of the following conditions: pre-diabetes, diabetes, high blood pressure, high triglycerides, low HDL, abdominal obesity, and BMI \>25 kg/m2.

You may not qualify if:

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
  • Recent heart attack, stroke, heart surgery, and congestive heart failure.
  • Participants who have unmanaged diabetes, chest pain or difficulty breathing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

Location

Related Publications (1)

  • Dandeneau D, Leon S, Cameranesi M, Alexiuk M, Protudjer J, Bohm C, DiNella M, Solmundson C, Talson M, Wang H, Whitlock R, Rigatto C, Mollard RC. Evaluation of an online cardiometabolic and weight loss program: a mixed methods study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0190.

MeSH Terms

Conditions

Metabolic SyndromeWeight LossMotor Activity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
16 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 8, 2021

First Posted

March 5, 2021

Study Start

March 1, 2021

Primary Completion

May 31, 2022

Study Completion

July 31, 2022

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations