Pre-diabetic StateNCT00302055
Feasibility of a Partnered Approach to Prevent Diabetes
A study testing Clinical referral to diabetes prevention lifestyle and Clinical referral to group diabetes prevention lifestyle in people with Pre-diabetic State and Overweight, run by Northwestern University at 2 sites in United States.
Trial summary
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type 2 diabetes in those at increase risk for the disease. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Pre-diabetic State, Overweight, Obesity
- What is being tested?
- Clinical referral to diabetes prevention lifestyle and Clinical referral to group diabetes prevention lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Jul 2007
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 years of age or older Body-mass index of >= 24 kg/m2
- or more additional risk factors if age is <45
- Parent or sibling with diabetes
- Minority race or ethnicity
- History of gestational diabetes
- Delivery of infant >= 9 lbs.
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- History of high blood pressure
- History of dyslipidemia
- Polycystic Ovarian Syndrome
- History of vascular disease Fasting Capillary Glucose 95 - 125 mg/dl 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Who cannot join
- Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years
- Significant Cardiovascular Disease
- A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire
- Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- Heart attack, stroke, or transient ischemic attack within 6 months
- Chest pain or unexplained dizziness or fainting with physical exertion
Show all 16Show fewer
- Chronic obstructive pulmonary disease or asthma needing home oxygen
- Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to <5 years
- Any other known reason for not participating in regular physical activity
- Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes
- Use of a medications known to produce hyperglycemia
- Known disease leading to abnormal glucose metabolism
- Exclusions for conditions / behaviors likely to affect study conduct
- Unable or unwilling to provide informed consent
- Unable to communicate with the pertinent clinic staff
- Unable to read written English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Medical Group Westside Clinic
Indianapolis, Indiana, 46222
IU Medical Group Banta Road Clinic
Indianapolis, Indiana, 46227
About this study
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type 2 diabetes in those at increase risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful DPP translation will require a sustainable partnership between a health care system and an established community organization committed to community health and experienced in implementing sustainable health and wellness programs. We have been collaborating with local health system and community administrators for over a year to design a 'real-world' clinic-based screening model to identify and refer high-risk patients for a group-based adaptation of the DPP lifestyle intervention in community facilities. We have designed this study to develop preliminary data about the feasibility and yield of clinic-based screening and referral, as well as the effectiveness of the adapted lifestyle intervention. This pilot study seeks to: 1) evaluate the feasibility of a strategy to implement American Diabetes Association (ADA) recommendations for clinic-based diabetes-risk testing and to refer high-risk patients for a community-based lifestyle intervention; 2) compare two strategies to enhance community-based program participation by referred patients; 3) demonstrate the capability of community facilities to schedule and enroll referred clinic patients at high-risk for diabetes and to deliver a modified, group-based DPP lifestyle intervention consistently; and 4) compare levels of weight loss and physical activity achieved by referred clinic patients with pre-diabetes who participate in a free-of-charge, group-based DPP lifestyle intervention at community facilities compared to a free-of-charge, traditional, one-on-one DPP lifestyle intervention at a DPP research site. Addressing these issues now will enable us to evaluate this partnered DPP translation model with a larger, more robust future study that will involve referral by multiple primary care clinics, program delivery at more community sites, and a 3-year follow-up period.
- Conditions
- Pre-diabetic State, Overweight, Obesity
- Being tested
- Clinical referral to diabetes prevention lifestyle, Clinical referral to group diabetes prevention lifestyle
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical referral to diabetes prevention lifestyleBehavioural
16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
Clinical referral to group diabetes prevention lifestyleBehavioural
16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
| Study group | Role | What they receive |
|---|---|---|
| one-on-one lifestyle | Active comparator | Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus Receives: Behavioral: Clinical referral to diabetes prevention lifestyle |
| group-based community lifestyle | Experimental | Clinical referral to group diabetes prevention lifestyle intervention program in community Receives: Behavioral: Clinical referral to group diabetes prevention lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)
Measured: 12 months
Secondary outcomes (2)
Self Report Physical Activity
Measured: 12 months
Rate of Community Program Participation
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 posted13 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionJul 2007
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.
- Other trials for Pre-diabetic StateStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Ackermann, Northwestern University
- Investigators
- Ronald T Ackermann, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302055
- Sponsor's protocol ID
- DK71527 (completed)
- Status last verified
- Oct 2016
- First submitted
- 10 Mar 2006
- Last updated
- 1 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Partnered Approach to Prevent Diabetes
- ClinicalTrials.gov ID
- NCT00302055
- Acronym / sponsor ID
- DK71527 (completed)
- Conditions
- Pre-diabetic State, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Mar 2006 (estimated)
- Results
- Posted 18 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type 2 diabetes in those at increase risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful DPP translation will require a sustainable partnership between a health care system and an established community organization committed to community health and experienced in implementing sustainable health and wellness programs. We have been collaborating with local health system and community administrators for over a year to design a 'real-world' clinic-based screening model to identify and refer high-risk patients for a group-based adaptation of the DPP lifestyle intervention in community facilities. We have designed this study to develop preliminary data about the feasibility and yield of clinic-based screening and referral, as well as the effectiveness of the adapted lifestyle intervention. This pilot study seeks to: 1) evaluate the feasibility of a strategy to implement American Diabetes Association (ADA) recommendations for clinic-based diabetes-risk testing and to refer high-risk patients for a community-based lifestyle intervention; 2) compare two strategies to enhance community-based program participation by referred patients; 3) demonstrate the capability of community facilities to schedule and enroll referred clinic patients at high-risk for diabetes and to deliver a modified, group-based DPP lifestyle intervention consistently; and 4) compare levels of weight loss and physical activity achieved by referred clinic patients with pre-diabetes who participate in a free-of-charge, group-based DPP lifestyle intervention at community facilities compared to a free-of-charge, traditional, one-on-one DPP lifestyle intervention at a DPP research site. Addressing these issues now will enable us to evaluate this partnered DPP translation model with a larger, more robust future study that will involve referral by multiple primary care clinics, program delivery at more community sites, and a 3-year follow-up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one-on-one lifestyle | Active comparator | Behavioral: Clinical referral to diabetes prevention lifestyleClinical referral to diabetes prevention lifestyle intervention at School of Medicine campus |
| group-based community lifestyle | Experimental | Behavioral: Clinical referral to group diabetes prevention lifestyleClinical referral to group diabetes prevention lifestyle intervention program in community |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 25 years of age or older Body-mass index of >= 24 kg/m2
- or more additional risk factors if age is <45
Key exclusion criteria (16 listed)
- Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years
- Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes
- Exclusions for conditions / behaviors likely to affect study conduct
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 |
|---|---|---|
| Clinical referral to diabetes prevention lifestyle16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions | Behavioural | one-on-one lifestyle |
| Clinical referral to group diabetes prevention lifestyle16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions | Behavioural | group-based community lifestyle |
Primary outcome
Weight Loss
Time frame: 12 months
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)
2 secondary outcomes
Self Report Physical Activity
Time frame: 12 months
Rate of Community Program Participation
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 1 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ronald T Ackermann, MD, MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical referral to diabetes prevention lifestyle and Clinical referral to group diabetes prevention lifestyle in people with Pre-diabetic State and Overweight, run by Northwestern University at 2 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 10 inclusion and 16 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 18 Dec 2014). 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?
Weight Loss (time frame: 12 months). 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 1 Dec 2016.