DiabetesNCT00970294
Pilot Project of Health Promotion for People With Diabetes
A study testing Health Promotion Program in people with Diabetes, run by Patricia Kluding, PhD at 1 site in United States.
Trial summary
Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Health Promotion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes type II
- age 40-70
Who cannot join
- hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
- significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
- recent symptoms of chest discomfort
- currently smoking or significant pulmonary pathology
- serious musculoskeletal problems that would limit ability to exercise
- current active involvement in a regular exercise program (> 3 times per week)
Show all 10Show fewer
- open wounds on the weight bearing surface of the feet
- not able to ambulate independently
- stroke or other central nervous system pathology
- stage 2 hypertension (resting blood pressure > 160 systolic or > 100 diastolic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes
Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.
- Conditions
- Diabetes
- Being tested
- Health Promotion Program
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion ProgramBehavioural
10 week health promotion program 3-4 times per week
| Study group | Role | What they receive |
|---|---|---|
| Health Promotion Program | Experimental | Supervised exercise, educational sessions, dietary counseling Receives: Behavioral: Health Promotion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment, Retention, Adherence
% of enrolled subjects who completed the trial
Measured: 10 weeks
Secondary outcomes (2)
Aerobic Fitness
peak VO2 as measured with a graded maximal exercise test on a cycle ergometer
Measured: Baseline and at 10 weeks (change score)
Glycemic Control
HbA1c measure
Measured: Baseline and at 10 weeks (change score)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJul 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patricia Kluding, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patricia Kluding, PhD, University of Kansas Medical Center
- Investigators
- Patricia Kluding, PhD, Study director, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970294
- Sponsor's protocol ID
- 10946
- Status last verified
- Jul 2012
- First submitted
- 1 Sep 2009
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epub 2010 Jun 8.
PubMed 20530663
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00970294
- Acronym / sponsor ID
- 10946
- Conditions
- Diabetes
- Keywords
- diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Patricia Kluding, PhDUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Promotion Program | Experimental | Behavioral: Health Promotion ProgramSupervised exercise, educational sessions, dietary counseling |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diabetes type II
- age 40-70
Key exclusion criteria (10 listed)
- hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
- significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
- recent symptoms of chest discomfort
- currently smoking or significant pulmonary pathology
- serious musculoskeletal problems that would limit ability to exercise
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 |
|---|---|---|
| Health Promotion Program10 week health promotion program 3-4 times per week | Behavioural | Health Promotion Program |
Primary outcome
Recruitment, Retention, Adherence
Time frame: 10 weeks
% of enrolled subjects who completed the trial
2 secondary outcomes
Aerobic Fitness
Time frame: Baseline and at 10 weeks (change score)
Glycemic Control
Time frame: Baseline and at 10 weeks (change score)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20530663Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epub 2010 Jun 8.
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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.
Patricia Kluding, PhD study director
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Promotion Program in people with Diabetes, run by Patricia Kluding, PhD 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 2 inclusion and 10 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 21 Aug 2012. 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?
Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment, Retention, Adherence (time frame: 10 weeks). 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 NCT00970294, 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 21 Aug 2012.