Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one-on-one lifestyle | Active Comparator | Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus |
|
| group-based community lifestyle | Experimental | Clinical referral to group diabetes prevention lifestyle intervention program in community |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical referral to diabetes prevention lifestyle | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Self Report Physical Activity | 12 months | |
| Rate of Community Program Participation | 6 months |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald T Ackermann, MD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Medical Group Westside Clinic | Indianapolis | Indiana | 46222 | United States | ||
| IU Medical Group Banta Road Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | One-on-one Lifestyle | Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus |
| FG001 | Group-based Community Lifestyle | Clinical referral to group diabetes prevention lifestyle intervention program in community |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | One-on-one Lifestyle | Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus |
| BG001 | Group-based Community Lifestyle | Clinical referral to group diabetes prevention lifestyle intervention program in community |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months) | Posted | Mean | 95% Confidence Interval | kilograms | 12 months |
|
Not provided
Adverse events are solicited from participants at every follow-up measurement time point.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | One-on-one Lifestyle | Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald T Ackermann | Northwestern University | (312) 503-6400 | r.ackermann@northwestern.edu |
Not provided
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clinical referral to group diabetes prevention lifestyle | Behavioral | 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 |
|
| Indianapolis |
| Indiana |
| 46227 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Self Report Physical Activity | Not Posted | 12 months |
| Secondary | Rate of Community Program Participation | Not Posted | 6 months |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Group-based Community Lifestyle | Clinical referral to group diabetes prevention lifestyle intervention program in community | 0 | 49 | 0 | 49 |
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |