Diabetes Exercise and Lifestyle Trial (DEAL)

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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