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| ID | Type | Description | Link |
|---|---|---|---|
| R34DK070702 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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 increased risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful community translation of the DPP's findings will require close collaboration with an established community organization committed to improving community health and experienced in implementing sustainable health and wellness programs. With exceptional reach into diverse U.S. communities, the Young Mens Christian Association (YMCA) may be an ideal community partner. We have been collaborating with the YMCA organization for over a year to design a robust recruitment and implementation model that is sensitive to the unique needs and resources of a community organization. We now propose to evaluate if a group-based adaptation of the DPP lifestyle intervention can be successfully implemented by YMCA staff, in YMCA facilities. We have designed this study to develop preliminary data about the reach, effectiveness, and consistent implementation of the DPP lifestyle intervention in this context. This pilot study has two primary aims: 1) to demonstrate the extent to which YMCA staff trained by DPP study personnel can administer a group-based adaptation of the DPP lifestyle intervention in a fashion consistent with DPP intervention protocols, and 2) to evaluate if the intervention program delivered by the YMCA results in changes in body mass, physical activity, and dietary intake that are consistent with a level found to be associated with diabetes risk reduction during the DPP trial. We will also collect valuable data about the feasibility and reach of a selective, community-based marketing and screening approach for recruiting program participants. In combination, these data will enable us to design and conduct a larger, future 3-year trial focusing on the effectiveness and sustainability of community DPP translation in multiple YMCA settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Brief Counseling Plus Group Lifestyle | Experimental | Brief counseling plus group diabetes prevention in community |
|
| 2: Brief Counseling Alone | Active Comparator | Brief Counseling for pre-diabetes alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief counseling plus group diabetes prevention in community | Behavioral | Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk, Group diabetes prevention in community: 16 weekly group lifestyle behavior change visits followed by monthly group lifestyle behavior change visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | 6 months minus baseline | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Level | Baseline, 6 months | |
| Rate of Community Program Participation | Baseline, 6 months | |
| Change in Dietary Composition |
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Inclusion Criteria:
i. 18 years of age or older ii. Body-mass index of >= 24 kg/m2 iii. ADA diabetes risk assessment score >= 10 (see below) iv. Casual capillary blood glucose >= 110 mg/dl
Exclusion Criteria:
i. Exclusions for diseases likely to limit life span and/or increase risk of interventions:
A. Cancer requiring treatment in the past 5 years
B. Cardiovascular disease:
ii. Exclusions related to metabolism: A. Diabetes at baseline evaluation B. Casual capillary blood glucose >= 200 mg/dl C. History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
D. Pregnant female E. Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
iii. Exclusion for conditions or behaviors likely to affect the conduct of the study:
A. Unable or unwilling to provide informed consent B. Unable to communicate with the pertinent clinic staff C. Unable to read written English
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| Name | Affiliation | Role |
|---|---|---|
| Ronald T Ackermann, MD, MPH | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Diabetes Prevention and Control Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: 1: Brief Counseling Plus Group Lifestyle | Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community |
| FG001 | Active Comparator: 2: Brief Counseling Alone | Brief Counseling for pre-diabetes alone without access to group lifestyle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: 1: Brief Counseling Plus Group Lifestyle | Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community |
| BG001 | Active Comparator: 2: Brief Counseling Alone |
| 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 | Change in Weight | 6 months minus baseline | Posted | Mean | 95% Confidence Interval | percentage of change in weight | Baseline, 6 months |
|
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Serious and/or other [non-serious] adverse events were not specifically elicited from participants in this minimal risk small pilot trial. However, none were spontaneously reported by participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: 1: Brief Counseling Plus Group Lifestyle | Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald T. Ackermann | Northwestern University | 3126036400 | r.ackermann@northwestern.edu |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012111 | Residence Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
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|
| Brief Counseling for pre-diabetes alone | Behavioral | Brief counseling at measurement visits: education about diabetes and the importance of medical follow-up for determining the most appropriate strategies to decrease this risk. |
|
| Baseline, 6 months |
Brief Counseling for pre-diabetes alone without access to group lifestyle
| 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 | Physical Activity Level | Not Posted | Baseline, 6 months | Participants |
| Secondary | Rate of Community Program Participation | Not Posted | Baseline, 6 months | Participants |
| Secondary | Change in Dietary Composition | Not Posted | Baseline, 6 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Active Comparator: 2: Brief Counseling Alone | Brief Counseling for pre-diabetes alone without access to group lifestyle | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004778 |
| Environment and Public Health |