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

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT02061579

Collaborator

(none)

354

Enrollment

Location

Arms

Actual Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Structured Group Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

354 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Once-Weekly Structured Contact Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week. They will engage in aerobic and resistance training for approximately 80 minutes per exercise session. Additionally, they will attend three exercise evaluations and six study visits.	Behavioral: Structured Group Exercise The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
Experimental: Thrice-Weekly Structured Contact Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week. In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week. Additionally, they will attend three exercise evaluations and six study visits.	Behavioral: Structured Group Exercise The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
No Intervention: Usual Care Participants in the Usual Care group will not take part in an 6-month exercise intervention. They will continue to seek regular care from their primary care providers and attend six study visits.

Arm

Intervention/Treatment

Experimental: Once-Weekly Structured Contact

Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week. They will engage in aerobic and resistance training for approximately 80 minutes per exercise session. Additionally, they will attend three exercise evaluations and six study visits.

Behavioral: Structured Group Exercise

The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.

Experimental: Thrice-Weekly Structured Contact

Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week. In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week. Additionally, they will attend three exercise evaluations and six study visits.

Behavioral: Structured Group Exercise

No Intervention: Usual Care

Participants in the Usual Care group will not take part in an 6-month exercise intervention. They will continue to seek regular care from their primary care providers and attend six study visits.

Outcome Measures

Primary Outcome Measures

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

Changes in Body Weight 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 Waist Circumference 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 Dietary Intake Across Study Visits [Baseline, 3-, 6-, 18-, 24-, 30-month follow-up]
Changes in Self-Reported Quality of Life 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Latha Palaniappan, MD, MS, Principal Investigator, Stanford University

ClinicalTrials.gov Identifier:

NCT02061579

Other Study ID Numbers:

31635
U.S. NIH Grant 5R18DK096394

First Posted:

Feb 13, 2014

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Keywords provided by Latha Palaniappan, MD, MS, Principal Investigator, Stanford University

Physical Activity

Additional relevant MeSH terms:

Diabetes Mellitus

Study Results

No Results Posted as of Mar 17, 2021