A Pilot Study Evaluating a Clinically Managed Weight Loss Program

Overview

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.

Full Title of Study: “A Pilot Study Evaluating the Clinically Managed Weight Loss Program at the Wellness Institute at Seven Oaks General Hospital”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 26, 2021

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

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Manitoba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dylan MacKay. PhD, Assistant Professor – University of Manitoba

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.