A Pilot Study Evaluating a Clinically Managed Weight Loss Program

A Pilot Study Evaluating the Clinically Managed Weight Loss Program At the Wellness Institute At Seven Oaks General Hospital

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Weight Loss Program

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2P2W7
      • Wellness Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Weight Loss Program; Single arm, all participants receive the weight loss program

Behavioral: Weight Loss Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight Loss	Weight will be measured in kg to the nearest 0.1 kg using a InBody 570 scale	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months
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.	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance	Attendance will be measured by checking if participants have attended each appointment with the health care professional as implemented by the program.	4 months
Intervention Adherence	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.	4 months
Waist Circumference	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.	4 months
Body fat percentage	The InBody 570 Body Composition Analyzer will measure body fat percentage by bioelectrical impedance.	4 months
Lean mass percentage	The InBody 570 Body Composition Analyzer will measure lean mass percentage by bioelectrical impedance.	4 months
Systolic Blood Pressure	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.	4 months
Diastolic Blood Pressure	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.	4 months
Heart Rate	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.	4 months
Total cholesterol	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.	4 months
High density lipoprotein cholesterol	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.	4 months
Low density lipoprotein cholesterol	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.	4 months
Triglyceride	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.	4 months
total cholesterol and high density lipoprotein cholesterol ratio	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.	4 months
Hemoglobin A1C	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.	4 months

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): February 26, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: exercise; psychology; nutrition; pilot study; program evaluation
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: HS22267 (H2018:401)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No