Pre DiabetesNCT01409889
Comparing Diabetes Prevention Programs
A study testing Diabetes Prevention Program and Healthy Living Program in people with Pre Diabetes and Diabetes, run by University of Rochester at 4 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre Diabetes, Diabetes
- What is being tested?
- Diabetes Prevention Program and Healthy Living Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2011to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- diagnosed with pre-diabetes
Who cannot join
- diagnosed with diabetes
- pregnant or nursing
- unable to walk 2-3 blocks in 10 minutes
- unable to read and speak English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anthony Jordan Health Center
Rochester, New York, 14605
Rochester General Medical Associates
Rochester, New York, 14605
Unity Health System
Rochester, New York, 14606
Westside Health Services
Rochester, New York, 14611
About this study
Official title: Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study
The purpose of this study is to compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice.
- Conditions
- Pre Diabetes, Diabetes
- Being tested
- Diabetes Prevention Program, Healthy Living Program
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention ProgramBehavioural
Also called DPP
Healthy Living ProgramBehavioural
Also called HLP
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevetion Program | Active comparator | Individuals in this group will receive the Diabetes Prevention Program Receives: Behavioral: Diabetes Prevention Program |
| Healthy Living Program | Active comparator | Individuals in this group will receive the Healthy Living Program Receives: Behavioral: Healthy Living Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Weight
7% reduction in participant weight
Measured: 22 weeks
Secondary outcomes (1)
Minutes of Physical Activity
Increase physical activity to 150 minutes per week.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Bennett, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409889
- Sponsor's protocol ID
- CTSI 5-27805
- Status last verified
- Jan 2016
- First submitted
- 2 Aug 2011
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Practice-Based Diabetes Prevention Programs - A Pilot Study
- ClinicalTrials.gov ID
- NCT01409889
- Acronym / sponsor ID
- CTSI 5-27805
- Conditions
- Pre Diabetes, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Aug 2011 (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 purpose of this study is to compare the effectiveness and costs of two programs,the Diabetes Prevention Program and the community-developed Healthy Living Program, delivered in an primary care practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevetion Program | Active comparator | Behavioral: Diabetes Prevention ProgramIndividuals in this group will receive the Diabetes Prevention Program |
| Healthy Living Program | Active comparator | Behavioral: Healthy Living ProgramIndividuals in this group will receive the Healthy Living Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 18 years old
- diagnosed with pre-diabetes
Key exclusion criteria (4 listed)
- diagnosed with diabetes
- pregnant or nursing
- unable to walk 2-3 blocks in 10 minutes
- unable to read and speak English
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 |
|---|---|---|
| Diabetes Prevention ProgramAlso: DPP | Behavioural | Diabetes Prevetion Program |
| Healthy Living ProgramAlso: HLP | Behavioural | Healthy Living Program |
Primary outcome
Participant Weight
Time frame: 22 weeks
7% reduction in participant weight
1 secondary outcome
Minutes of Physical Activity
Time frame: 22 weeks
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 18 Jan 2016.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Program and Healthy Living Program in people with Pre Diabetes and Diabetes, run by University of Rochester at 4 sites 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 4 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 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Participant Weight (time frame: 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2016; AzTrials last refreshed its copy on 29 Oct 2026.