A Pilot Study Evaluating a Clinically Managed Weight Loss Program

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04290910
• Other study ID #: HS22267 (H2018:401)
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: June 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 1, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Canada	Wellness Institute	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Body fat percentage	The InBody 570 Body Composition Analyzer will measure body fat percentage by bioelectrical impedance.	4 months
Other	Lean mass percentage	The InBody 570 Body Composition Analyzer will measure lean mass percentage by bioelectrical impedance.	4 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Body Weight Loss	Weight will be measured in kg to the nearest 0.1 kg using a InBody 570 scale	4 months
Secondary	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
Secondary	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