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A Pilot Study Evaluating a Clinically Managed Weight Loss Program

Not Applicable
Completed
Conditions
Obesity
Interventions
Behavioral: Weight Loss Program
Registration Number
NCT04290910
Lead Sponsor
University of Manitoba
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
43
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Weight Loss ProgramWeight Loss ProgramSingle arm, all participants receive the weight loss program
Primary Outcome Measures
NameTimeMethod
Body Weight Loss4 months

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

Secondary Outcome Measures
NameTimeMethod
Changes in Quality of Life4 months

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 Quality4 months

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.

Trial Locations

Locations (1)

Wellness Institute

🇨🇦

Winnipeg, Manitoba, Canada

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