PrediabetesPhase 2NCT00886340
A Lifestyle Change Program to Prevent Type 2 Diabetes
A Phase 2 study testing Lifestyle counseling in people with Prediabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Aug 2008
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21 or older
- medically stable and safe to exercise
- at high risk for type 2 diabetes
- able to speak English.
Who cannot join
- Type 2 diabetes
- Cardiovascular disease
- Cancer requiring treatment in the past 5 years
- Anemia
- Hepatitis
- Renal disease
Show all 17Show fewer
- Gastrointestinal disease
- Recent or significant abdominal surgery
- Pulmonary disease with dependence on oxygen or daily use of bronchodilators
- Chronic infection (ie., HIV, active tuberculosis)
- Unable to walk 0.25 miles in 10 minutes
- Participation in commercial diet program
- Currently pregnant or within 3 months postpartum
- Currently nursing or within 6 weeks of having completed nursing
- Treatment of impaired glucose tolerance (IGT) with metformin
- Currently taking any glucocorticoid or beta-blocker
- Recently prescribed or changed dose of a statin (within 2 months)
About this study
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.
- Conditions
- Prediabetes
- Being tested
- Enhanced standard care, Lifestyle counseling
- Keywords
- diabetes prevention, primary care
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced standard careBehavioural
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
Lifestyle counselingBehavioural
Enhanced standard care Six appointments with nurse practitioner (20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Enhanced standard care | Active comparator | Not described Receives: Behavioral: Enhanced standard care |
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
Measured: 6 months
Secondary outcomes (3)
Diet and Exercise Behavior
Measured: 6 months
Lipids
Measured: 6 months
Quality of Life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startSep 2005
- Primary completionSep 2007
- Study completionAug 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 PrediabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Robin Whittemore, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Investigators
- Robin Whittemore, PhD, Principal investigator, Yale School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886340
- Sponsor's protocol ID
- DK70594 (completed)
- Status last verified
- Apr 2012
- First submitted
- 22 Jan 2009
- Last updated
- 7 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Whittemore R, Melkus G, Wagner J, Dziura J, Northrup V, Grey M. Translating the diabetes prevention program to primary care: a pilot study. Nurs Res. 2009 Jan-Feb;58(1):2-12. doi: 10.1097/NNR.0b013e31818fcef3.
PubMed 19092550
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lifestyle Change Program to Prevent Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00886340
- Acronym / sponsor ID
- DK70594 (completed)
- Conditions
- Prediabetes
- Keywords
- diabetes prevention, primary care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 22 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced standard care | Active comparator | Behavioral: Enhanced standard care |
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counseling |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 21 or older
- medically stable and safe to exercise
- at high risk for type 2 diabetes
- able to speak English.
Key exclusion criteria (17 listed)
- Type 2 diabetes
- Cardiovascular disease
- Cancer requiring treatment in the past 5 years
- Anemia
- Hepatitis
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 |
|---|---|---|
| Enhanced standard careOne appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes) | Behavioural | Enhanced standard care |
| Lifestyle counselingEnhanced standard care Six appointments with nurse practitioner (20 minutes) | Behavioural | Lifestyle counseling |
Primary outcome
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
Time frame: 6 months
3 secondary outcomes
Diet and Exercise Behavior
Time frame: 6 months
Lipids
Time frame: 6 months
Quality of Life
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19092550Whittemore R, Melkus G, Wagner J, Dziura J, Northrup V, Grey M. Translating the diabetes prevention program to primary care: a pilot study. Nurs Res. 2009 Jan-Feb;58(1):2-12. doi: 10.1097/NNR.0b013e31818fcef3.
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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.
Robin Whittemore, PhD principal investigator
Yale School of Nursing
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lifestyle counseling in people with Prediabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 4 inclusion and 17 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 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2009). 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?
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss (time frame: 6 months). 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 NCT00886340, 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 7 May 2012.