Overweight, Prediabetes
Conditions
Keywords
Prediabetes, Overweight, African American, Women, Cooking, Nutrition, Exercise, Stress Management
Brief summary
To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.
Detailed description
Control group: These participants will continue to receive their usual care from their primary medical care team. Intervention group: The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education
Interventions
BEHAVIORALStress Management
Every other week
BEHAVIORALDiet
Every other week
BEHAVIORALExercise
Every week
BEHAVIORALCulinary education
Every other week
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Study participants must: 1. Be capable of giving informed consent 2. Understand and voluntarily sign the informed consent form. 3. Be females at least 18 years of age and identify themselves as African-American 4. Have prediabetes as defined by the American Diabetes Association: history of glycated hemoglobin (HgbA1c) 5.7-6.4 % or fasting blood glucose 100-125 mg/dL (5.6-6.9 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose 140-199 mg/dL (7.8-11.0 mmol/L) during an oral glucose tolerance test (as described by the World Health Organization using a glucose load of 75 g anhydrous glucose dissolved in water) 5. Have a body mass index (BMI, defined as weight in kilograms divided by height in meters squared) greater than or equal to 25
Exclusion criteria
1. Current or previous diagnosis of diabetes or a history of HgbA1c ≥ 6.5% or fasting blood glucose ≥ 126 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test or a history of classic symptoms of hyperglycemia or hyperglycemic crisis and a random plasma glucose ≥ 200 mg/dL (11.1 mmol/L). 2. Normal glycemia or a currently with a HgbA1c \< 5.7% or fasting blood glucose \< 100 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose \< 140 mg/dL (11.1 mmol/L) during an oral glucose tolerance test 3. Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin 4. Male gender 5. History of congestive heart failure 6. History of renal failure, dialysis, or creatinine greater than 2 mg/dL 7. History of liver failure or a liver dysfunction with a increase by a factor of 2 above the upper limit of normal in alanine aminotransferase or aspartate aminotransferase 8. History of gastrointestinal disorder that would prevent adherence to the recommended diet (e.g. celiac disease, inflammatory bowel disease, history of bariatric surgery, history of intestinal surgery) 9. Presence of active cancer 10. History of coronary artery disease or cerebrovascular disease 11. History of uncontrolled hypertension 12. Participation in another lifestyle modification trial 13. Pregnancy or lactating or planning to be pregnant 14. Current alcoholism or abuse of recreational drugs 15. Hospitalization for depression in past 12 months 16. Travel plans that do not permit full participation or participant lives too far from Health Center to permit full participation 17. History of bariatric surgery, small bowel resection, or extensive bowel resection 18. Chronic treatment with systemic steroids 19. Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder 20. Inability to walk two blocks 21. Other medial, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol 22. Amputation of lower limb for nontraumatic causes 23. Self report of HIV-positivity or active tuberculosis 24. Documented history of pulmonary embolus in past six months 25. Chronic obstructive pulmonary disease that would limit ability to follow the study protocol 26. Self-reported chronic hepatitis B or C or cirrhosis; inflammatory bowel disease requiring treatment in past year; Cushing's syndrome; acromegaly (clinical diagnosis or self-report); any major organ transplant 27. Unwilling or uninterested in participating in group lifestyle education sessions 28. Current regular corticosteroid use 29. Active polycystic ovarian syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of FRESH Program on Weight Loss | Baseline line and final followup visit (at 8-14 weeks) | Change in weight measured at baseline and followup (at 8-14 weeks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diet - Daily Calorie Intake | Baseline and final followup visit (at 8-14 weeks) | Change in daily caloric intake as measured by online 24-hour recall dietary program |
| Exercise | Baseline and final followup visits (at 8-14 weeks) | Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks). |
| Stress | baseline and followup visit (at 8-14 weeks) | Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome. |
| Sleep | baseline and followup visit (at 8-14 weeks) | Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between May and August, 2012. Recruitment methods included flyers distributed to health centers, libraries, and community health outreach events; advertisements in Cleveland Clinic and Community newsletters; and a television appearance on popular Sunday morning news program by one of the research team members.
Pre-assignment details
Two participants who were enrolled in study were excluded at baseline laboratory check due to glycated hemoglobin (HgbA1c) value below 5.7%.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Control Group These participants will continue to receive their usual care from their primary medical care team. | 13 |
| Arm B: Intervention Group Arm includes diet instruction, exercise, stress management, and culinary education
Exercise : Every week
Diet : Every other week
Culinary education : Every other week
Stress Management : Every other week | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Arm B: Intervention Group | Arm A: Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Continuous | 57.7 years STANDARD_DEVIATION 11.4 | 54.1 years STANDARD_DEVIATION 9.3 | 55 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Effect of FRESH Program on Weight Loss
Change in weight measured at baseline and followup (at 8-14 weeks).
Time frame: Baseline line and final followup visit (at 8-14 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Control Group | Effect of FRESH Program on Weight Loss | -0.5 kg | Standard Deviation 2 |
| Arm B: Intervention Group | Effect of FRESH Program on Weight Loss | -0.2 kg | Standard Deviation 2.2 |
Comparison: No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.p-value: 0.7295% CI: [-1.4, 2]t-test, 2 sided
Secondary
Diet - Daily Calorie Intake
Change in daily caloric intake as measured by online 24-hour recall dietary program
Time frame: Baseline and final followup visit (at 8-14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Control Group | Diet - Daily Calorie Intake | 172.2 Kcal/day |
| Arm B: Intervention Group | Diet - Daily Calorie Intake | 36.5 Kcal/day |
Comparison: No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.p-value: 0.31Wilcoxon (Mann-Whitney)
Secondary
Exercise
Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).
Time frame: Baseline and final followup visits (at 8-14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Control Group | Exercise | -1290 steps/day |
| Arm B: Intervention Group | Exercise | 253.4 steps/day |
p-value: 0.31Wilcoxon (Mann-Whitney)
Secondary
Sleep
Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).
Time frame: baseline and followup visit (at 8-14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Control Group | Sleep | 0.0 hours/night |
| Arm B: Intervention Group | Sleep | 0.0 hours/night |
Secondary
Stress
Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.
Time frame: baseline and followup visit (at 8-14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A: Control Group | Stress | 0.5 scores on a scale |
| Arm B: Intervention Group | Stress | -1.0 scores on a scale |
p-value: 0.53Wilcoxon (Mann-Whitney)