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NCT Number: NCT04290910

A Pilot Study Evaluating a Clinically Managed Weight Loss Program

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.

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Key information

Conditions

Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellness Institute

Winnipeg, Manitoba, R2P2W7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight Loss Program

Behavioral

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 outcomes

  1. Body Weight Loss

    Time frame: 4 months

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

Secondary outcomes

  1. Changes in Quality of Life

    Time frame: 4 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.

  2. Changes in Sleep Quality

    Time frame: 4 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.

Other outcomes

  1. Attendance

    Time frame: 4 months

    Attendance will be measured by checking if participants have attended each appointment with the health care professional as implemented by the program.

  2. Intervention Adherence

    Time frame: 4 months

    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.

  3. Waist Circumference

    Time frame: 4 months

    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. Body fat percentage

    Time frame: 4 months

    The InBody 570 Body Composition Analyzer will measure body fat percentage by bioelectrical impedance.

  5. Lean mass percentage

    Time frame: 4 months

    The InBody 570 Body Composition Analyzer will measure lean mass percentage by bioelectrical impedance.

  6. Systolic Blood Pressure

    Time frame: 4 months

    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.

  7. Diastolic Blood Pressure

    Time frame: 4 months

    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.

  8. Heart Rate

    Time frame: 4 months

    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.

  9. Total cholesterol

    Time frame: 4 months

    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.

  10. High density lipoprotein cholesterol

    Time frame: 4 months

    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.

  11. Low density lipoprotein cholesterol

    Time frame: 4 months

    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.

  12. Triglyceride

    Time frame: 4 months

    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.

  13. total cholesterol and high density lipoprotein cholesterol ratio

    Time frame: 4 months

    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.

  14. Hemoglobin A1C

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2020
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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