Diabetes MellitusIMPACTNCT02061579
Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
A study testing Structured Group Exercise in people with Diabetes Mellitus, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Structured Group Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Structured Group Exercise
- Keywords
- Physical Activity
- Medical subject headings
- Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Group ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hemoglobin A1c Level Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Maximal Oxygen Consumption Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary outcomes (9)
Changes in Body Weight Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Mass Index Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Waist Circumference Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Blood Pressure Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Heart Rate Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Dietary Intake Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Quality of Life Across Study Visits
Measured: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Exercise Perception Across Study Visits
Measured: Baseline, 6-, 30-month follow-up
Changes in Patient Satisfaction During Intervention Period
Measured: 3-, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startOct 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Latha Palaniappan, MD, MS, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061579
- Sponsor's protocol ID
- 31635
- Other IDs
- U.S. NIH Grant 5R18DK096394
- Acronym
- IMPACT
- Status last verified
- Mar 2021
- First submitted
- 11 Feb 2014
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36542382
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
- ClinicalTrials.gov ID
- NCT02061579
- Acronym / sponsor ID
- IMPACT / 31635
- Conditions
- Diabetes Mellitus
- Keywords
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Once-Weekly Structured Contact | Experimental | Behavioral: Structured Group ExerciseParticipants 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. |
| Thrice-Weekly Structured Contact | Experimental | Behavioral: Structured Group ExerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Group ExerciseThe 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. | Behavioural | Once-Weekly Structured Contact, Thrice-Weekly Structured Contact |
Primary outcome
Changes in Hemoglobin A1c Level Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Maximal Oxygen Consumption Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
9 secondary outcomes
Changes in Body Weight Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Mass Index Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Waist Circumference Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Blood Pressure Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Heart Rate Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Dietary Intake Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Quality of Life Across Study Visits
Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Exercise Perception Across Study Visits
Time frame: Baseline, 6-, 30-month follow-up
Changes in Patient Satisfaction During Intervention Period
Time frame: 3-, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 36542382Mukherji 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Group Exercise in people with Diabetes Mellitus, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hemoglobin A1c Level Across Study Visits (time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.