Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, obesity, prevention
Brief summary
This worksite program for Onondaga County employees is a pilot research study aimed at decreasing the risk of developing diabetes (or improving metabolic control for adults with diabetes). The main goal is to improve the nutrition and physical habits of the participants, and promote weight loss in those who are overweight. The investigators will also examine factors that predict participation in the program and influence a participant's outcome/success in the program.
Interventions
BEHAVIORALDiabetes Prevention and Control
The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings.
Sponsors
County of Onondaga, NYS
NYS Department of Health
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult employees of Onondaga County
Exclusion criteria
* Not an employee of Onondaga County * Less than age 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 3 months | Weight loss in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose Level | Baseline | Fasting glucose (mg/dL) |
| Fasting Lipid Profile | Baseline | LDL-cholesterol (mg/dL) |
| Hemoglobin A1c | baseline | hemoglobin A1c (%) |
| Waist Circumference | baseline, 3, 6, 12 months | — |
| Questionnaires | baseline, 3, 6, 12 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention A 3 month program (12 one hour weekly sessions) that targets healthy diet, physical activity and stress reduction, and then a monthly maintenance program for up to 2 years.
Diabetes Prevention and Control: The program will be delivered over 3 months in 12 one hour weekly mid-day sessions at the worksite. The curriculum has been adapted from the Diabetes Prevention Program, the National Diabetes Education Program and Conversation maps from Healthy Interactions Inc. Topics relate to healthy eating, physical activity, coping with disease and depression, and cardiovascular disease prevention. Additional topics may be included per feedback and need of the participants. After completion of the 3 month program, there will be monthly meetings. | 21 |
| Control This is a wait control group, This group will begin the program (described in A,1) after 3 months. | 24 |
| Total | 45 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 9.6 | 51.2 years STANDARD_DEVIATION 6.4 | 51.2 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 21 participants | 24 participants | 45 participants |
| Sex: Female, Male Female | 17 Participants | 21 Participants | 38 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 24 |
| serious Total, serious adverse events | 0 / 45 | 0 / 24 |
Outcome results
Primary
Body Weight
Weight loss in kg
Time frame: 3 months
Population: Participants from the wait-list Control Arm have been combined in the Intervention Arm with those receiving the intervention immediately upon study entry for the purposes of this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Body Weight | -2.3 kg |
| Control | Body Weight | 0.73 kg |
Comparison: Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in -2LL).p-value: <0.01Mixed Models Analysis
Secondary
Fasting Glucose Level
Fasting glucose (mg/dL)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Fasting Glucose Level | 107 mg/dL | Standard Deviation 36 |
| Control | Fasting Glucose Level | 111 mg/dL | Standard Deviation 36 |
Secondary
Fasting Lipid Profile
LDL-cholesterol (mg/dL)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Fasting Lipid Profile | 126 mg/dL | Standard Deviation 24 |
| Control | Fasting Lipid Profile | 112 mg/dL | Standard Deviation 34 |
Secondary
Hemoglobin A1c
hemoglobin A1c (%)
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Hemoglobin A1c | 6.2 percent | Standard Deviation 1.3 |
| Control | Hemoglobin A1c | 6.4 percent | Standard Deviation 1.3 |
Secondary
Questionnaires
Time frame: baseline, 3, 6, 12 months
Secondary
Waist Circumference
Time frame: baseline, 3, 6, 12 months