Obese, Overweight, Prediabetes
Conditions
Keywords
lifestyle risk reduction
Brief summary
The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.
Detailed description
The lifestyle intervention includes a 16-week group-based program which targets weight reduction through the adoption of a lower fat diet and greater physical activity.
Interventions
BEHAVIORALLifestyle counseling
16-week nutrition, physical activity and behavioral intervention
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old * overweight or obese * prediabetes with elevated glucose value
Exclusion criteria
* recent cardiovascular event * use of corticosteroids * concurrent participation in a structured weight loss program * pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 4 months | Change in body weight |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Counseling Diabetes Prevention Program lifestyle intervention
Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention | 40 |
| Usual Care Usual care from primary care physician | 38 |
| Total | 78 |
Baseline characteristics
| Characteristic | Lifestyle Counseling | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 50.75 years STANDARD_DEVIATION 9.49 | 50.55 years STANDARD_DEVIATION 7.99 | 50.65 years STANDARD_DEVIATION 8.73 |
| Region of Enrollment United States | 40 participants | 38 participants | 78 participants |
| Sex: Female, Male Female | 31 Participants | 30 Participants | 61 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
Primary
Body Weight
Change in body weight
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | Body Weight | -5.12 kg | Standard Error 0.63 |
| Usual Care | Body Weight | -0.37 kg | Standard Error 0.64 |
p-value: <0.0001ANOVA
Primary
Body Weight
Change in body weight
Time frame: 7 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | Body Weight | -4.86 kg | Standard Error 0.62 |
| Usual Care | Body Weight | -0.35 kg | Standard Error 0.64 |
p-value: <0.0001ANOVA