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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04290910
Enrollment
43
Registered
2020-03-02
Start date
2019-01-01
Completion date
2021-06-01
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

pilot study, program evaluation, nutrition, exercise, psychology

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.

Interventions

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.

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Body Weight Loss4 monthsWeight will be measured in kg to the nearest 0.1 kg using a InBody 570 scale

Secondary

MeasureTime frameDescription
Changes in Quality of Life4 monthsQuality 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 Quality4 monthsSleep 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.

Other

MeasureTime frameDescription
Body fat percentage4 monthsThe InBody 570 Body Composition Analyzer will measure body fat percentage by bioelectrical impedance.
Lean mass percentage4 monthsThe InBody 570 Body Composition Analyzer will measure lean mass percentage by bioelectrical impedance.
Systolic Blood Pressure4 monthsSystolic 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.
Diastolic Blood Pressure4 monthsDiastolic 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.
Heart Rate4 monthsHeart 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.
Attendance4 monthsAttendance will be measured by checking if participants have attended each appointment with the health care professional as implemented by the program.
High density lipoprotein cholesterol4 monthsDiagnostic 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.
Low density lipoprotein cholesterol4 monthsDiagnostic 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.
Triglyceride4 monthsDiagnostic Services of Manitoba will collect and process the participants blood samples and measure the triglyceride concentration in mmol/L according to their established protocols.
total cholesterol and high density lipoprotein cholesterol ratio4 monthsDiagnostic 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.
Hemoglobin A1C4 monthsDiagnostic Services of Manitoba will collect and process the participants blood samples and measure the hemoglobin A1C as a percentage according to their established protocols.
Total cholesterol4 monthsDiagnostic 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.
Intervention Adherence4 monthsIntervention 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.
Waist Circumference4 monthsWaist 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026