Prediabetes
Conditions
Keywords
diabetes prevention, primary care
Brief summary
The purpose of this study was to evaluate the effect of a diabetes prevention program provided by nurse practitioners in primary care to adults at risk for diabetes.
Interventions
BEHAVIORALEnhanced standard care
One appointment with nurse practitioner (20 minutes) One appointment with nutritionist (45 minutes)
BEHAVIORALLifestyle counseling
Enhanced standard care Six appointments with nurse practitioner (20 minutes)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 21 or older * medically stable and safe to exercise * at high risk for type 2 diabetes * able to speak English.
Exclusion criteria
* Type 2 diabetes * Cardiovascular disease * Cancer requiring treatment in the past 5 years * Anemia * Hepatitis * Renal disease * Gastrointestinal disease * Recent or significant abdominal surgery * Pulmonary disease with dependence on oxygen or daily use of bronchodilators * Chronic infection (ie., HIV, active tuberculosis) * Unable to walk 0.25 miles in 10 minutes * Participation in commercial diet program * Currently pregnant or within 3 months postpartum * Currently nursing or within 6 weeks of having completed nursing * Treatment of impaired glucose tolerance (IGT) with metformin * Currently taking any glucocorticoid or beta-blocker * Recently prescribed or changed dose of a statin (within 2 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Met Weight Loss Goal of 5% Weight Loss | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Diet and Exercise Behavior | 6 months |
| Lipids | 6 months |
| Quality of Life | 6 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Standard Care Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist) | 27 |
| Lifestyle Counseling Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner) | 31 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 7 |
Baseline characteristics
| Characteristic | Enhanced Standard Care | Lifestyle Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 27 Participants | 53 Participants |
| Age Continuous | 43.2 years STANDARD_DEVIATION 13.2 | 48.2 years STANDARD_DEVIATION 12.4 | 45.7 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 24 Participants | 28 Participants | 52 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 31 |
| serious Total, serious adverse events | 0 / 27 | 0 / 31 |
Outcome results
Primary
Number of Participants Who Met Weight Loss Goal of 5% Weight Loss
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Standard Care | Number of Participants Who Met Weight Loss Goal of 5% Weight Loss | 3 participants |
| Lifestyle Counseling | Number of Participants Who Met Weight Loss Goal of 5% Weight Loss | 6 participants |
Comparison: pilot test, used 20% of sample required for a full test of the hypothesisp-value: 0.08Mixed Models Analysis
Secondary
Diet and Exercise Behavior
Time frame: 6 months
Secondary
Lipids
Time frame: 6 months
Secondary
Quality of Life
Time frame: 6 months