search
Back to results

A Pilot Study Evaluating a Clinically Managed Weight Loss Program

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Weight Loss Program
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring pilot study, program evaluation, nutrition, exercise, psychology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the trial.
  • Male or female, aged 18 years or above.
  • Are overweight or obese (BMI over 24.9)

Exclusion Criteria:

- Female participant who is pregnant or lactating.

Sites / Locations

  • Wellness Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weight Loss Program

Arm Description

Single arm, all participants receive the weight loss program

Outcomes

Primary Outcome Measures

Body Weight Loss
Weight will be measured in kg to the nearest 0.1 kg using a InBody 570 scale

Secondary Outcome Measures

Changes in Quality of Life
Quality of life will be measured through the SF-36 quality of life questionnaire. The SF-36 measures nine areas: physical functioning, role functioning (emotional), role functioning (physical), energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. A higher score indicate greater levels of quality of life.
Changes in Sleep Quality
Sleep will be measured through the Pittsburgh Sleep Quality Index questionnaire. The Pittsburgh Sleep Quality Index questionnaire measures the quality and pattern of sleep in adults, and includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. A score of 5 or less is indicated as good sleep quality where a score of 6 or more is indicated as poor sleep quality.

Full Information

First Posted
February 27, 2020
Last Updated
June 25, 2021
Sponsor
University of Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT04290910
Brief Title
A Pilot Study Evaluating a Clinically Managed Weight Loss Program
Official Title
A Pilot Study Evaluating the Clinically Managed Weight Loss Program at the Wellness Institute at Seven Oaks General Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
February 26, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

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

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
This is a pilot study evaluating a clinically managed weight loss program. The program consists of a 17-week weight loss program which involves a multidisciplinary team where personalized interventions are given to participants from the team based on the participants goals.
Detailed Description
The clinically managed weight loss program is managed by a clinical team including a Program Manager, Registered Dietitians, Canadian Society of Exercise Physiology-Certified Personal Trainers, Clinical Psychology Associate or Cognitive Behavioural Therapist, and a Physician. The team will collaborate together to prescribe a plan best suited for the participants' needs with the focus on lifestyle changes, such as, sleep, mental health, and behaviours. Outcome measures will be collected as part of the pilot study, such as, anthropometric measurements and body composition, cardiovascular assessment, clinical chemistry, physical activity, nutrition, and behaviour and health screening questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
pilot study, program evaluation, nutrition, exercise, psychology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Loss Program
Arm Type
Experimental
Arm Description
Single arm, all participants receive the weight loss program
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Program
Intervention Description
There are three components of the intervention, this includes: psychology, nutrition, and physical activity. For the psychological portion, a therapist will assess the participant at baseline to determine if there are barriers associated with making lifestyle changes. For nutrition, the dietitian will assess the participant and create a meal plan based on their nutritional needs and guide the participant to reaching their nutritional goals. The psychological and nutrition portion may be interchangeable depending on the participants needs. For physical activity, the personal trainer will assess the participant and create an exercise plan that consists of resistance training and weight bearing exercises suitable for the participant while also guiding the participant to reach their exercise goals.
Primary Outcome Measure Information:
Title
Body Weight Loss
Description
Weight will be measured in kg to the nearest 0.1 kg using a InBody 570 scale
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Changes in Quality of Life
Description
Quality of life will be measured through the SF-36 quality of life questionnaire. The SF-36 measures nine areas: physical functioning, role functioning (emotional), role functioning (physical), energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. A higher score indicate greater levels of quality of life.
Time Frame
4 months
Title
Changes in Sleep Quality
Description
Sleep will be measured through the Pittsburgh Sleep Quality Index questionnaire. The Pittsburgh Sleep Quality Index questionnaire measures the quality and pattern of sleep in adults, and includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. A score of 5 or less is indicated as good sleep quality where a score of 6 or more is indicated as poor sleep quality.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Attendance
Description
Attendance will be measured by checking if participants have attended each appointment with the health care professional as implemented by the program.
Time Frame
4 months
Title
Intervention Adherence
Description
Intervention adherence will be measured by checking if participants have attended each appointment with the health care professional as implemented by the program. If the participant has attended 80% or more of their appointments, this would be classified as good intervention adherence to the program.
Time Frame
4 months
Title
Waist Circumference
Description
Waist circumference in cm will be measured in triplicate, to the nearest 0.1 cm at the umbilicus, between the last rib and iliac crest using a fibreglass tape measured by an exercise professional.
Time Frame
4 months
Title
Body fat percentage
Description
The InBody 570 Body Composition Analyzer will measure body fat percentage by bioelectrical impedance.
Time Frame
4 months
Title
Lean mass percentage
Description
The InBody 570 Body Composition Analyzer will measure lean mass percentage by bioelectrical impedance.
Time Frame
4 months
Title
Systolic Blood Pressure
Description
Systolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.
Time Frame
4 months
Title
Diastolic Blood Pressure
Description
Diastolic blood pressure in mmHg is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.
Time Frame
4 months
Title
Heart Rate
Description
Heart rate in beats per minute is measured in triplicate, on the non-dominant arm in a sitting position by an exercise professional using a validated oscillometric blood pressure monitor.
Time Frame
4 months
Title
Total cholesterol
Description
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol concentration in mmol/L according to their established protocols.
Time Frame
4 months
Title
High density lipoprotein cholesterol
Description
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the high density lipoprotein cholesterol concentration in mmol/L according to their established protocols.
Time Frame
4 months
Title
Low density lipoprotein cholesterol
Description
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the low density lipoprotein cholesterol concentration in mmol/L according to their established protocols.
Time Frame
4 months
Title
Triglyceride
Description
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the triglyceride concentration in mmol/L according to their established protocols.
Time Frame
4 months
Title
total cholesterol and high density lipoprotein cholesterol ratio
Description
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the total cholesterol and high density lipoprotein cholesterol ratio according to their established protocols.
Time Frame
4 months
Title
Hemoglobin A1C
Description
Diagnostic Services of Manitoba will collect and process the participants blood samples and measure the hemoglobin A1C as a percentage according to their established protocols.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the trial. Male or female, aged 18 years or above. Are overweight or obese (BMI over 24.9) Exclusion Criteria: - Female participant who is pregnant or lactating.
Facility Information:
Facility Name
Wellness Institute
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2P2W7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study Evaluating a Clinically Managed Weight Loss Program

We'll reach out to this number within 24 hrs