HyperglycemiaRAPIDNCT00656682
Primary Care Community Partnerships to Prevent Diabetes
A study testing Dietitian Counseling Alone and Dietitian Plus Community Group Lifestyle in people with Hyperglycemia and Obesity, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Obesity, Diabetes Mellitus
- What is being tested?
- Dietitian Counseling Alone and Dietitian Plus Community Group Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2013
- 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
- 18 years of age or older
- Body-mass index of 24 kg/m2 or greater
- Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Who cannot join
- Cancer requiring treatment in the past 5 years
- Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- Heart attack, stroke, or transient ischemic attack in the past 6 months,
- Chronic obstructive airways disease or asthma requiring 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
- Pregnancy
Show all 12Show fewer
- Existing diagnosis of diabetes mellitus
- Fasting capillary blood glucose > 125 mg/dl
- 2-hour post-challenge capillary blood glucose > 199 mg/dl
- History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
- Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics)
- Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.
Read the detailed description
Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.
- Conditions
- Hyperglycemia, Obesity, Diabetes Mellitus
- Being tested
- Dietitian Counseling Alone, Dietitian Plus Community Group Lifestyle
- Keywords
- Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis
- Medical subject headings
- Hyperglycemia, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietitian Counseling AloneBehavioural
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
Dietitian Plus Community Group LifestyleBehavioural
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes
| Study group | Role | What they receive |
|---|---|---|
| Dietitian Counseling Alone | Active comparator | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone Receives: Behavioral: Dietitian Counseling Alone |
| Dietitian Plus Community Group Lifestyle | Experimental | Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention. Receives: Behavioral: Dietitian Plus Community Group Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change in Body Weight
(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)
Measured: 12 months
Secondary outcomes (9)
% Change in Blood Total Cholesterol
(total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)
Measured: 12 months
% Change in glycosylated hemoglobin
(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)
Measured: 12 months
% Change in Blood Pressures
(mean SBP at 12 months - mean SBP at baseline) / (mean SBP at baseline); (mean DBP at 12 months - mean DBP at baseline) / (mean DBP at baseline)
Measured: 12 months
Changes in Dietary Composition
NHIS Multifactor Screener: Change in % dietary kcal from fat at 12 months (est % dietary Kcal from fat at 12 months - est % dietary Kcal from fat at baseline)
Measured: 12 months
Changes in Physical Activity
Paffenbarger PAQ: (Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at 12 months - Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at Baseline)
Measured: 12 months
Incremental Costs
Measured: 12 months
Incremental Health State Utility
Measured: 12 months
% Change in Body Weight
(weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)
Measured: 6 months
% Change in Body Weight
(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 509 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 School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656682
- Sponsor's protocol ID
- R18DK079855
- Other IDs
- R18DK079855
- Acronym
- RAPID
- Status last verified
- Aug 2014
- First submitted
- 10 Apr 2008
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Community Partnerships to Prevent Diabetes
- ClinicalTrials.gov ID
- NCT00656682
- Acronym / sponsor ID
- RAPID / R18DK079855
- Conditions
- Hyperglycemia, Obesity, Diabetes Mellitus
- Keywords
- Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Apr 2008 (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 determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.
Detailed description
Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietitian Counseling Alone | Active comparator | Behavioral: Dietitian Counseling AlonePrimary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone |
| Dietitian Plus Community Group Lifestyle | Experimental | Behavioral: Dietitian Plus Community Group LifestylePrimary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Body-mass index of 24 kg/m2 or greater
- Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Key exclusion criteria (12 listed)
- Cancer requiring treatment in the past 5 years
- Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- Heart attack, stroke, or transient ischemic attack in the past 6 months,
- Chronic obstructive airways disease or asthma requiring 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
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 |
|---|---|---|
| Dietitian Counseling AlonePrimary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian | Behavioural | Dietitian Counseling Alone |
| Dietitian Plus Community Group LifestylePrimary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes | Behavioural | Dietitian Plus Community Group Lifestyle |
Primary outcome
% Change in Body Weight
Time frame: 12 months
(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)
9 secondary outcomes
% Change in Blood Total Cholesterol
Time frame: 12 months
% Change in glycosylated hemoglobin
Time frame: 12 months
% Change in Blood Pressures
Time frame: 12 months
Changes in Dietary Composition
Time frame: 12 months
Changes in Physical Activity
Time frame: 12 months
Incremental Costs
Time frame: 12 months
Incremental Health State Utility
Time frame: 12 months
% Change in Body Weight
Time frame: 6 months
% Change in Body Weight
Time frame: 24 months
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 29 Mar 2018.
- 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 School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietitian Counseling Alone and Dietitian Plus Community Group Lifestyle in people with Hyperglycemia and Obesity, run by Northwestern 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 29 Mar 2018. 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?
% Change in Body Weight (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 29 Mar 2018.