Diabetes Exercise and Lifestyle Trial (DEAL)

University of Calgary

Status and phase: Unknown; Early Phase 1

Conditions: Diabetes Mellitus

Treatments: Behavioral: Low volume combined A/R exercise, printouts, pedometers; Behavioral: Control; Behavioral: Low volume combined aerobic/resistance exercise; Behavioral: High volume combined A/R exercise, printouts, pedometers; Behavioral: Printed PA information, pedometers and step log group; Behavioral: High volume combined aerobic/resistance exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00877864

CHREB 22251

DEAL- 22251

Details and patient eligibility

About

The objective of this study is to determine the effects of supervised combined aerobic and resistance training, and the effects of stage-matched written materials delivered by mail or internet, alone or in combination, on glycemic control as reflected in A1C (glycated hemoglobin).

Full description

Background Rationale: Structured, supervised exercise programs involving aerobic exercise, resistance exercise or their combination resulted in significant improvements in glycemic control in type 2 diabetes. It has also been shown that programs which include a psychological/behavioral component in addition to diet and exercise have been most effective for long-term treatment of obesity in diabetes. The supervised exercise program has stronger evidence for improvement of metabolic control and cardiac risk, but its longer-term sustainability has not been demonstrated, and it is relatively costly. A stage-matched printed materials/pedometer intervention has been shown to increase physical activity over a longer period of time, and likely at a lower per-patient cost than the supervised exercise intervention, but with less evidence for improvement of metabolic control.

Enrollment: 26 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• type 2 diabetes
• A1c 0.700-0.099
• ability to read and write English
• signed ICF

Exclusion criteria

• participation in previous 6 months in exercise > 2 times per week for at least 20 min per session
• insulin therapy changes in medication for diabetes, BP or Lipids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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26 participants in 6 patient groups, including a placebo group

High volume combined aerobic/resistance exercise

Active Comparator group

Treatment:

Behavioral: High volume combined aerobic/resistance exercise

Low volume combined aerobic/resistance exercise

Active Comparator group

Description:

Low volume combined aerobic/resistance exercise

Treatment:

Behavioral: Low volume combined aerobic/resistance exercise

High volume combined A/R exercise, printouts, pedometers

Active Comparator group

Description:

High volume combined aerobic/resistance exercise, printouts, pedometers

Treatment:

Behavioral: High volume combined A/R exercise, printouts, pedometers

Low volume combined A/R exercise, printouts, pedometers

Active Comparator group

Description:

Low volume combined aerobic/resistance exercise, printouts, pedometers

Treatment:

Behavioral: Low volume combined A/R exercise, printouts, pedometers

Printed PA information, pedometers and step log group

Active Comparator group

Description:

Printed physical activity information, pedometers and step log group

Treatment:

Behavioral: Printed PA information, pedometers and step log group

Control

Placebo Comparator group

Treatment:

Behavioral: Control