Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT02061579
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Start: 2016-10
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Hemoglobin A1c Level Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Maximal Oxygen Consumption Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

Secondary Outcome Measures

Name	Time	Method
Changes in Self-Reported Quality of Life Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Mass Index Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Blood Pressure Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Heart Rate Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Weight Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Waist Circumference Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Exercise Perception Across Study Visits	Baseline, 6-, 30-month follow-up
Changes in Patient Satisfaction During Intervention Period	3-, 6-month follow-up
Changes in Dietary Intake Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States