Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Glucose Intolerance
  • Mild Cognitive Impairment
  • Overweight and Obesity
  • Sedentary Behavior
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of nine weeks. Each condition will consist of one day supervised in the laboratory followed by six at-home days, following lab protocol as closely as possible.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

This study will be a randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of ...

This study will be a randomized crossover trial and reported in accordance with CONSORT guidelines. The study will involve a total of three seven-day conditions (2 experimental and 1 control) with a three-week washout period in-between to minimize practice effects for a total intervention period of nine weeks (see figure 1). Each condition will consist of one day supervised in the laboratory followed by six at-home days, following lab protocol as closely as possible. Participants will be referred to the study by their physician. Interested participants will be asked to contact the researcher by email or phone call. Interested Participants will be invited into the lab for a familiarization session. They will be instructed to avoid caffeine, alcohol and MVPA for 48 hours prior to this session. During this session the following information will be obtained; Written informed consent Height using a stadiometer and weight using a standard beam scale Demographics questionnaire (education, ethnicity, family background, comorbidities) Physical Activity Readiness Questionnaire (PARQ+) (Bredin, Gledhill, Jamnik, & Warburton, 2013) Resting blood pressure- will be measured once on each arm and then twice on the left arm with an automated BP monitor The participants will be educated/familiarized on the following; Cognitive assessments - Cambridge Neuropsychological Test Automated Battery (CANTAB) Fitting with an inclinometer (activPAL4) Participants will be visited at their home ~72hrs prior to each condition to be fitted with the CGM and ActivPal. They will also be instructed to avoid caffeine, alcohol and MVPA for 48 hours prior to each of the three conditions. Dinner will be consumed between 7:00 and 9:00 pm, allowing for a 10 hour fast prior to the experimental condition the next morning. All participants will be instructed to arrive at the laboratory (with minimal activity during commute) at approximately 7:00 am. Upon arrival, participants will be asked to use the washroom and then rest for 30 minutes preceding a blood pressure measurement and first cognitive assessment. The participants will undergo the CANTAB cognitive assessments (at ~7:30 am) before meal consumption. A standardized breakfast meal will be consumed at 8:00 am, followed by lunch at 12:00 pm and dinner at 5:00 pm. Participants will be allotted 20 minutes for full meal consumption. The CANTAB cognitive assessments will then be re-administered at approximately 7:30 pm. Participants will be supervised throughout the conditions to ensure adherence to the protocols and will be permitted to watch DVDs, read books, magazines, newspapers, talk and/or work on a laptop computer. However, what they do during the first condition will be documented and then replicated for the remaining experimental conditions. Intensity of the bout intervals will be kept to an RPE of 6-9 using the Borg RPE scale. Once the 12- hour laboratory component is complete, participants will be sent home (still wearing the CGM and activPAL) with the intension of replicating the laboratory-based protocol after each meal in their own free-living environment. Participants will track their mealtimes by sending photos to the researcher before consumption during the 6 at home days. The researcher will then go to the participants house on the last day (day 7) of each condition to re-administer the CANTAB cognitive assessments and collect the CGM, and activPal. There will then be a 3-week washout period, followed by replication of protocol for the remaining two conditions.

Tracking Information

NCT #
NCT04323423
Collaborators
Not Provided
Investigators
Principal Investigator: Harry Prapavessis, Ph.D Western University