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Diabetes Exercise and Lifestyle Trial

Diabetes Exercise and Lifestyle Trial

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00877864
Acronym
DEAL
Enrollment
26
Registered
2009-04-08
Start date
2010-02-28
Completion date
2012-12-31
Last updated
2011-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

diabetes, exercise, printed materials

Brief summary

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).

Detailed 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.

Interventions

BEHAVIORALHigh volume combined aerobic/resistance exercise

High volume combined aerobic/resistance exercise

BEHAVIORALLow volume combined aerobic/resistance exercise

Low volume combined aerobic/resistance exercise

BEHAVIORALHigh volume combined A/R exercise, printouts, pedometers

High volume combined aerobic/resistance exercise, printouts, pedometers

BEHAVIORALLow volume combined A/R exercise, printouts, pedometers

Low volume combined aerobic/resistance exercise, printouts, pedometers

BEHAVIORALPrinted PA information, pedometers and step log group

Printed PA information, pedometers and step log group

BEHAVIORALControl

No exercise program provided by the study

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The primary outcome will be A1c at the end of 6 months supervised exercise period.6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026