Trial Outcomes & Findings for Canadian Health Advanced By Nutrition and Graded Exercise (NCT NCT01616563)

NCT ID: NCT01616563

Last Updated: 2021-02-21

Results Overview

Percentage of the prescribed diet visits visits attended over 12 months. Each participant was to attend a total of 21 prescribed diet visits over 12 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 305 participants
• Primary outcome timeframe: At 12 months
• Results posted on: 2021-02-21

Participant Flow

A total of 305 patients were recruited from 3 participating primary care clinics from Oct 2012 to December 2014. Of these, 12 patients were excluded, 10 that no longer met the inclusion criteria and 2 that met an exclusion criteria by the time the study started. A total of 293 patients were included in the analysis.

Participant milestones

Measure	Diet and Exercise Intervention A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Overall Study STARTED	293
Overall Study COMPLETED	253
Overall Study NOT COMPLETED	40

Reasons for withdrawal

Measure	Diet and Exercise Intervention A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Overall Study Lost to Follow-up	40

Baseline Characteristics

Canadian Health Advanced By Nutrition and Graded Exercise

Baseline characteristics by cohort

Measure	Diet and Exercise Intervention n=293 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Age, Continuous	59.1 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	152 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants
Region of Enrollment Canada	293 participants n=5 Participants
Body Mass Index	31.9 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants
PROCAM risk %	8.2 % STANDARD_DEVIATION 6.4 • n=5 Participants
Estimated V02 Max percentile	46.8 % STANDARD_DEVIATION 24 • n=5 Participants
Healthy Eating Index-Canadian	57.9 units on a scale STANDARD_DEVIATION 14.2 • n=5 Participants
Mediterranean Diet Score	4.7 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: At 12 months

Percentage of the prescribed diet visits visits attended over 12 months. Each participant was to attend a total of 21 prescribed diet visits over 12 months.

Outcome measures

Measure	Diet and Exercise Intervention n=5313 prescribed diet visits A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Feasibility of the Diet Intervention	4782 prescribed diet visits

PRIMARY outcome

Timeframe: At 12 months

Percentage of the prescribed exercise visits attended over 12 months. Each participant was to attend a total of 21 prescribed exercise visits over 12 months.

Outcome measures

Measure	Diet and Exercise Intervention n=5313 prescribed exercise visits A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Feasibility of the Exercise Intervention	4038 prescribed exercise visits

PRIMARY outcome

Timeframe: At 12 months compared to baseline measures

Population: Combined diet and exercise program

Metabolic syndrome is defined as having 3/5 of the following: elevated blood pressure (or on medication), elevated blood sugars (or on medication), elevated triglycerides (or on medication), low HDL-C and a large waist circumference. Reversal of metabolic syndrome is defined as having less than 3/5 criteria

Outcome measures

Measure	Diet and Exercise Intervention n=253 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Number of Participants That Have Reversal of Metabolic Syndrome	48 Participants

SECONDARY outcome

Timeframe: At 12 months compared to baseline

Population: % participants that had improvement in metabolic syndrome components

Improvements in blood pressure (or elimination of medication), blood sugars (or elimination of medication), triglycerides (or elimination of medication), HDL-C and waist circumference

Outcome measures

Measure	Diet and Exercise Intervention n=253 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome	106 Participants

SECONDARY outcome

Timeframe: Change at 12 months compared to baseline

Canadian Health Eating Index (HEI-C) is reported on a 100 point score with a higher score indicating a better outcome. A higher score means a better outcome. HEI-C is on a 100 point score.

Outcome measures

Measure	Diet and Exercise Intervention n=209 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Change From Baseline in Diet Quality-Canadian Healthy Eating Index	9.6 score on a scale out of 100 Interval 7.6 to 11.6

SECONDARY outcome

Timeframe: Change at 12 months compared to baseline

Mediterranean Diet Score (MDS) is reported on a 0-14 point score with a higher score indicating a better outcome.

Outcome measures

Measure	Diet and Exercise Intervention n=209 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Change From Baseline in Diet Quality-Mediterranean Diet Score	1.4 score on a scale out of 14 Interval 1.1 to 1.6

SECONDARY outcome

Timeframe: Change at 12 months compared to baseline

Estimated maximal oxygen consumption (VO2 max) standardized to age and sex

Outcome measures

Measure	Diet and Exercise Intervention n=182 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Change From Baseline in Aerobic Capacity	15.6 percentile Interval 13.3 to 17.9

SECONDARY outcome

Timeframe: Change at 12 months compared to baseline

Changes in PROCAM score, which estimates the risk of a myocardial infarction or dying from an acute coronary event within the next 10 years. Similar to Framingham risk score but for metabolic syndrome. A lower score means a better outcome. PROCAM score varies from 0-87,0 means there are no risk factors (pt is younger than 39), while 87 means the patient is a smoker and older than 60 years and presents all risk factors

Outcome measures

Measure	Diet and Exercise Intervention n=206 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Changes in Risk of Myocardial Infarction and Cardiac Events	1.4 percentage Interval 0.9 to 2.0

SECONDARY outcome

Timeframe: Change at 12 months compared to baseline

Metabolic syndrome risk score is a composite continuous score that measures the severity of metabolic syndrome as a continuous variable rather than dichotomized with arbitrary cut-points . The score is the principal component of waist circumference, glucose, systolic blood pressure, triglycerides. It has a mean of 0 and a standard deviation of 1 with higher score meaning greater risk. Reference Hillier TA, et al., Practical way to assess metabolic syndrome using a continuous score obtained from principal components analysis. Diabetologia (2006) 49:1528-1535

Outcome measures

Measure	Diet and Exercise Intervention n=206 Participants A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Changes in Continuous Metabolic Syndrome Risk Score	0.4 z-score Interval 0.3 to 0.5

Adverse Events

Diet and Exercise Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rupinder Dhaliwal

Metabolic Syndrome Canada

Phone: 613 484 3830

Email: rupinder.dhaliwal@metsc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place