Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 3P30DK079626-12S1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
Not provided
Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the Deep South. To address this problem, the University of Alabama (UAB) Diabetes Research Center (DRC) will establish a primary care clinical network in rural counties of Alabama and in the Mississippi delta that will provide the (DRC) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. A pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.
The pilot trial in aim three will include enrolling four primary care practices. Each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from each clinic will be assigned to one of two conditions:
Condition 1. Receive lifestyle modification alone (Diabetes Prevention Program (DPP).
Condition 2. Receive lifestyle modification (DPP) with metformin therapy recommendation.
Twenty five participants will be enrolled from each participating practice. Participants will be followed up for 12-14 months after recruitment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receive lifestyle modification alone (DPP) | Active Comparator | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services |
|
| Receive lifestyle modification with metformin therapy | Experimental | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receive lifestyle modification alone | Behavioral | Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Change in body weight from baseline to 12-months | 12 months |
| Change in Glycosylated Hemoglobin (HbA1c) | Change in glycosylated hemoglobin (HbA1c) point of care test values | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrea Cherrington, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB | Birmingham | Alabama | 35205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Receive Lifestyle Modification Alone (DPP) | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services Receive lifestyle modification alone: Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Metformin therapy | Behavioral | The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing. |
|
| FG001 | Receive Lifestyle Modification With Metformin Therapy | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation Receive lifestyle modification alone: Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. Metformin therapy: The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Receive Lifestyle Modification Alone (DPP) | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services Receive lifestyle modification alone: Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. |
| BG001 | Receive Lifestyle Modification With Metformin Therapy | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation Receive lifestyle modification alone: Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. Metformin therapy: The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body Weight | Mean | Standard Deviation | pounds |
|
| 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 Body Weight | Change in body weight from baseline to 12-months | Participants lost to follow-up | Posted | Mean | Standard Deviation | Pounds | 12 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Change in Glycosylated Hemoglobin (HbA1c) | Change in glycosylated hemoglobin (HbA1c) point of care test values | Participants lost to follow-up | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | 12 months |
|
12-months
Not provided
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 | Receive Lifestyle Modification Alone (DPP) | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services Receive lifestyle modification alone: Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG001 | Receive Lifestyle Modification With Metformin Therapy | Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation Receive lifestyle modification alone: Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone. Metformin therapy: The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing. | 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
COVID-19 greatly impacted ability to recruit participants and retain participants.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea L. Cherrington | University of Alabama at Birmingham | 205-996-2885 | acherrington@uabmc.edu |
| Dec 27, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2020 | Dec 27, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|