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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK083941 | 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 compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.
This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Lifestyle Advice | Active Comparator | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant). |
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| Advice Plus Lifestyle Intervention | Experimental | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Lifestyle Advice | Behavioral | Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Body Weight | (Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental Costs | The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms. | 6, 12, and 24 months |
| Changes in Health State Utility |
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Inclusion Criteria:
Exclusion Criteria (any of the following):
Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:
Significant cardiovascular disease:
Lung disease:
Pregnancy
Any other known condition that could limit ability to become physically active or limit life span to <5 years
Exclusions related to metabolism:
Exclusion for conditions or behaviors likely to affect the conduct of the study:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald T. Ackermann, MD, MPH | Northwestern University (Illinois) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YMCA of Metro Chicago | Chicago | Illinois | 60610 | United States | ||
| McGaw YMCA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26611433 | Result | Liss DT, Finch EA, Gregory DL, Cooper A, Ackermann RT. Design and participant characteristics for a randomized effectiveness trial of an intensive lifestyle intervention to reduce cardiovascular risk in adults with type 2 diabetes: The I-D-HEALTH study. Contemp Clin Trials. 2016 Jan;46:114-121. doi: 10.1016/j.cct.2015.11.016. Epub 2015 Dec 2. | |
| 29596950 | Derived | Liss DT, Finch EA, Cooper A, Sheth A, Tejuosho AD, Lancki N, Ackermann RT. One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial. Diabetes Res Clin Pract. 2018 Jun;140:36-44. doi: 10.1016/j.diabres.2018.03.030. Epub 2018 Mar 27. |
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Potential participants were prescreened on the phone and attended a baseline visit for further screening and enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Lifestyle Advice | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant). Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Advice Plus Lifestyle Intervention | Behavioral | Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team. |
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The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated. |
| Baseline to 6,12, and 24 months |
| Percent Change in Body Weight | Baseline to 6 and 24 months |
| Percent Change in Blood Total Cholesterol | Baseline to 6, 12, and 24 months |
| Percent Change in A1c | Baseline to 6, 12, and 24 months |
| Percent Change in Blood Pressure | Baseline to 6, 12, and 24 months |
| Percent Change in Dietary Composition | Baseline to 6, 12, and 24 months |
| Percent Change in Physical Activity | Baseline to 6, 12, and 24 months |
| Evanston |
| Illinois |
| 60201 |
| United States |
| FG001 | Advice Plus Lifestyle Intervention | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting. Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm. Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Lifestyle Advice | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant). Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months. |
| BG001 | Advice Plus Lifestyle Intervention | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting. Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm. Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percent Change in Body Weight | (Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss. | Participants who completed weight measurements at the baseline and 12 month exam | Posted | Mean | Standard Deviation | percentage of change | Baseline to 12 months |
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| Secondary | Incremental Costs | The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms. | Not Posted | 6, 12, and 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Health State Utility | The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated. | Not Posted | Baseline to 6,12, and 24 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Body Weight | Not Posted | Baseline to 6 and 24 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Blood Total Cholesterol | Not Posted | Baseline to 6, 12, and 24 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in A1c | Not Posted | Baseline to 6, 12, and 24 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Blood Pressure | Not Posted | Baseline to 6, 12, and 24 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Dietary Composition | Not Posted | Baseline to 6, 12, and 24 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Physical Activity | Not Posted | Baseline to 6, 12, and 24 months | Participants |
1 year
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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 | Standard Lifestyle Advice | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant). Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months. | 1 | 167 | 10 | 167 | 0 | 167 |
| EG001 | Advice Plus Lifestyle Intervention | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting. Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm. Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team. | 0 | 164 | 10 | 164 | 0 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia (severe: admitted to hospital, emergency room, or needed assistance by other person) | Endocrine disorders | Systematic Assessment |
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| Heart attack (myocardial infarction) | Cardiac disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Balloon angioplasty or Stenting of coronary arteries (Percutaneous transluminal coronary angioplasty | Surgical and medical procedures | Systematic Assessment |
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| Stroke (transient ischemic attack, cerebral ischemia/hemorrhage, or cerebrovascular accident) | Nervous system disorders | Systematic Assessment |
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| Cardiac Arryhythmia (atrial fibrillation or flutter) | Cardiac disorders | Systematic Assessment |
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| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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Over the 1 year measurement period, we experienced significant loss to follow-up in this diverse, predominantly low-income sample. We were only able to measure the primary outcome, body weight, on 257 of 331 participants at the 12 month visit.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Project Manager | Northwestern University | 312-503-3359 | emily.anderson1@northwestern.edu |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| D009765 | Obesity |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D050177 | Overweight |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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