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

NCT02061579 | Completed

• 2 other identifiers: 31635U.S. NIH Grant 5R18DK096394
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Physical Activity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (3)

Once-Weekly Structured Contact

EXPERIMENTAL

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

Thrice-Weekly Structured Contact

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Structured Group Exercise BEHAVIORAL

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.

Once-Weekly Structured Contact; Thrice-Weekly Structured Contact

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Mukherji AB, Lu D, Qin F, Hedlin H, Johannsen NM, Chung S, Kobayashi Y, Haddad F, Lamendola C, Basina M, Talamoa R, Myers J, Palaniappan L. Effectiveness of a Community-Based Structured Physical Activity Program for Adults With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2247858. doi: 10.1001/jamanetworkopen.2022.47858.

  PMID: 36542382 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: October 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)