Pre-diabetes
Conditions
Keywords
Obesity, Metformin Therapy
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALReceive 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.
BEHAVIORALMetformin 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 19 to 65 years * Body mass index (BMI) ≥30 * Receives care at one of the participating primary care clinics * HbA1c 6.0% to 6.4% * Resides in one location at least 5 days each week * Willing to attend group-based classes * Willing to work with a peer advisor in-person and over the phone * Has regular access to telephone or cellular phone * Willing and able to use telemonitoring body weight to conduct daily self-weighing * Estimated Glomerular Filtration Rate (eGFR) of ≥60 in their medical record within 6 months
Exclusion criteria
* Diabetes diagnosis or HbA1c \>6.4% or fasting glucose ≥126 * HbA1c \<6.0% * Pregnancy or anticipating pregnancy * Unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits * Likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months * Weight loss ≥5% of body weight in past 6 months (other than postpartum) * Past bariatric surgery * Prescription weight loss medications within the past 6 months * eGFR \< 60 within past 6 months * Unable to ambulate * Have end-stage medical conditions with limited life expectancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 12 months | Change in body weight from baseline to 12-months |
| Change in Glycosylated Hemoglobin (HbA1c) | 12 months | Change in glycosylated hemoglobin (HbA1c) point of care test values |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 7 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
Baseline characteristics
| Characteristic | Receive Lifestyle Modification Alone (DPP) | Receive Lifestyle Modification With Metformin Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 7 Participants | 36 Participants |
| Age, Continuous | 49.7 Years STANDARD_DEVIATION 10.3 | 47.0 Years STANDARD_DEVIATION 12.3 | 49.2 Years STANDARD_DEVIATION 10.7 |
| Body Weight | 264.4 pounds STANDARD_DEVIATION 44.78 | 251.9 pounds STANDARD_DEVIATION 69.07 | 258.3 pounds STANDARD_DEVIATION 57.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 5 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 2 Participants | 11 Participants |
| Region of Enrollment United States | 29 participants | 7 participants | 36 participants |
| Sex: Female, Male Female | 24 Participants | 6 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 7 |
| other Total, other adverse events | 0 / 29 | 0 / 7 |
| serious Total, serious adverse events | 0 / 29 | 0 / 7 |
Outcome results
Primary
Change in Body Weight
Change in body weight from baseline to 12-months
Time frame: 12 months
Population: Participants lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receive Lifestyle Modification Alone (DPP) | Change in Body Weight | -3.6 Pounds | Standard Deviation 11.87 |
| Receive Lifestyle Modification With Metformin Therapy | Change in Body Weight | -4.4 Pounds | Standard Deviation 3.21 |
Primary
Change in Glycosylated Hemoglobin (HbA1c)
Change in glycosylated hemoglobin (HbA1c) point of care test values
Time frame: 12 months
Population: Participants lost to follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Receive Lifestyle Modification Alone (DPP) | Change in Glycosylated Hemoglobin (HbA1c) | -0.1 Percentage of glycosylated hemoglobin | Standard Deviation 0.52 |
| Receive Lifestyle Modification With Metformin Therapy | Change in Glycosylated Hemoglobin (HbA1c) | -0.5 Percentage of glycosylated hemoglobin | Standard Deviation 0.99 |