Clinical trial NCT02061579: Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
Official title: Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Physical Activity
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.

Detailed description: The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants. Study participants will be randomized into three exercise group. Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months). Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months). Group 3 will not attend any instructor-led exercise training sessions. All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.

Eligibility criteria: Inclusion Criteria:

* Recent hemoglobin A1c result between 6.5 and 13.0%
* Diagnosed with Type 2 Diabetes Mellitus
* Able and willing to enroll and meet the requirements of the study

Exclusion Criteria:

* Inability to speak, read or understand English
* Long-term current use or dependency on insulin
* Systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg
* Resting heart rate \> 120 bpm
* History of or present heart or cardiovascular conditions
* History of or present respiratory disease
* History of or present spinal cord injury
* History of stroke or Transient Ischemic Attack (TIA)
* History of cancer diagnosis in the past 5 years or present cancer diagnosis
* Medical, psychiatric, behavioral limitations that may interfere with study participation
* Participating in other clinical trials that may interfere with study procedures and outcomes
* Currently pregnant or plans to become pregnant within three years

Primary outcomes:
measure: Changes in Hemoglobin A1c Level Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Maximal Oxygen Consumption Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Self-Reported Physical Activity Level Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary outcomes:
measure: Changes in Body Weight Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Body Mass Index Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Waist Circumference Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Blood Pressure Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Heart Rate Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Dietary Intake Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Self-Reported Quality of Life Across Study Visits
timeFrame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
measure: Changes in Exercise Perception Across Study Visits
timeFrame: Baseline, 6-, 30-month follow-up
measure: Changes in Patient Satisfaction During Intervention Period
timeFrame: 3-, 6-month follow-up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: