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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK078553 | 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 purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.
Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual Telephone Intervention | Experimental | Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. |
|
| Group Telephone Intervention | Active Comparator | Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual telephone intervention | Behavioral | Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight (kg) | baseline, 1, 2, 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg) | baseline, 1, 2, 3 years |
| Fasting Lipid Panel | LDL-cholesterol (mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth S. Weinstock, MD PhD | State University of New York - Upstate Medical University | Principal Investigator |
| Paula Trief, PhD | State University of New York - Upstate Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23843020 | Result | Weinstock RS, Trief PM, Cibula D, Morin PC, Delahanty LM. Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. J Gen Intern Med. 2013 Dec;28(12):1620-8. doi: 10.1007/s11606-013-2529-7. Epub 2013 Jul 11. | |
| 25251749 | Result | Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014 Dec;22(12):2532-8. doi: 10.1002/oby.20916. Epub 2014 Sep 24. |
| Label | URL |
|---|---|
| Weight Loss Success in Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study. | View source |
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Enrollment took place from June 22, 2009 - Oct 2, 2010 from 5 diverse primary care practice sites in upstate NY: Oneida Healthcare Center (small city), Pulaski Health Center (rural), Syracuse Community Healthcare Center and University Health Care Center (urban, poor, medium city), and University Internists (higher income, medium city).
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Calls | Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
| FG001 | Conference Calls | Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
| |||||||||||||
| Year 2 |
| |||||||||||||
| Year 3 (Observation) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Calls | Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Weight (kg) | Posted | Mean | Standard Deviation | kg | baseline, 1, 2, 3 years |
|
3 years
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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 | Individual Calls | Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices. Individual telephone intervention: Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth S. Weinstock MD PhD | SUNY Upstate Medical University | 315-464-5740 | weinstor@upstate.edu |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Group telephone intervention | Behavioral | Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
|
| baseline, 1, 2, 3 years |
| Fasting Glucose Level | Fasting glucose (mg/dL) | baseline, 1, 2, 3 years |
| Health Behaviors (Diet, Physical Activity) | National Cancer Institute Fat screener | baseline, 6 months, 1 and 2 years |
| SF-12 Physical Summary Score | The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health). | baseline, 6 months, 1 and 2 years |
| International Physical Activity Questionnaire | Measure of physical activity is calculated as in mets/week | baseline, 6 months, 1 and 2 years |
| 25451907 | Result | Trief PM, Weinstock RS, Cibula D, Delahanty LM. Sustained weight loss one year after group telephone intervention: 3-year results from the SHINE study. Diabetes Res Clin Pract. 2014 Dec;106(3):e74-8. doi: 10.1016/j.diabres.2014.09.032. Epub 2014 Oct 5. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Conference Calls | Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. |
|
|
|
| Secondary | Blood Pressure | Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg) | Posted | Mean | Standard Deviation | mmHg | baseline, 1, 2, 3 years |
|
|
|
| Secondary | Fasting Lipid Panel | LDL-cholesterol (mg/dL) | Note: LDL-cholesterol measurements were not available for 13 participants in the Individual Call arm and 6 participants in the Conference Call arm | Posted | Mean | Standard Deviation | mg/dL | baseline, 1, 2, 3 years |
|
|
|
| Secondary | Fasting Glucose Level | Fasting glucose (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | baseline, 1, 2, 3 years |
|
|
|
| Secondary | Health Behaviors (Diet, Physical Activity) | National Cancer Institute Fat screener | Posted | Mean | Standard Error | percentage of daily calories from fat | baseline, 6 months, 1 and 2 years |
|
|
|
| Secondary | SF-12 Physical Summary Score | The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health). | Posted | Mean | Standard Error | units on a scale | baseline, 6 months, 1 and 2 years |
|
|
|
| Secondary | International Physical Activity Questionnaire | Measure of physical activity is calculated as in mets/week | Posted | Mean | Standard Error | mets per week | baseline, 6 months, 1 and 2 years |
|
|
|
| 19 |
| 129 |
| 0 |
| 129 |
| EG001 | Conference Calls | Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices. Group telephone intervention: Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff. | 16 | 128 | 0 | 128 |
| Hospitalization | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization | Endocrine disorders | Systematic Assessment |
|
| Hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Hospitalization | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization | Hepatobiliary disorders | Systematic Assessment |
|
| Hospitalization | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hospitalization | Vascular disorders | Systematic Assessment |
|
| Hospitalization | Immune system disorders | Systematic Assessment |
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| Hospitalization | Infections and infestations | Systematic Assessment |
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| Hospitalizations | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization | Nervous system disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
| Systolic blood pressure Year 2 |
|
| Systolic blood pressure Year 3 |
|
| Diastolic blood pressure Baseline |
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| Diastolic blood pressure Year 1 |
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| Diastolic blood pressure Year 2 |
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| Diastolic blood pressure Year 3 |
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| Year 2 |
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| Year 3 |
|
| Year 2 |
|
| Year 3 |
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| Change from baseline at 2 years |
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| Change from baseline at 2 years |
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| Change from baseline at 2 years |
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