Trial Outcomes & Findings for FRESH Study (Fitness, Relaxation and Eating to Stay Healthy) (NCT NCT01636258)
NCT ID: NCT01636258
Last Updated: 2022-05-10
Results Overview
Change in weight measured at baseline and followup (at 8-14 weeks).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Baseline line and final followup visit (at 8-14 weeks)
Results posted on
2022-05-10
Participant Flow
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.
Two participants who were enrolled in study were excluded at baseline laboratory check due to glycated hemoglobin (HgbA1c) value below 5.7%.
Participant milestones
| Measure |
Arm A: Control Group
These participants will continue to receive their usual care from their primary medical care team.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Control Group
These participants will continue to receive their usual care from their primary medical care team.
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)
Baseline characteristics by cohort
| Measure |
Arm A: Control Group
n=13 Participants
These participants will continue to receive their usual care from their primary medical care team.
|
Arm B: Intervention Group
n=14 Participants
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
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
55 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline line and final followup visit (at 8-14 weeks)Change in weight measured at baseline and followup (at 8-14 weeks).
Outcome measures
| Measure |
Arm A: Control Group
n=12 Participants
These participants will continue to receive their usual care from their primary medical care team.
|
Arm B: Intervention Group
n=14 Participants
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
|
|---|---|---|
|
Effect of "FRESH" Program on Weight Loss
|
-0.5 kg
Standard Deviation 2.0
|
-0.2 kg
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline and final followup visit (at 8-14 weeks)Change in daily caloric intake as measured by online 24-hour recall dietary program
Outcome measures
| Measure |
Arm A: Control Group
n=12 Participants
These participants will continue to receive their usual care from their primary medical care team.
|
Arm B: Intervention Group
n=14 Participants
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
|
|---|---|---|
|
Diet - Daily Calorie Intake
|
172.2 Kcal/day
Interval -347.4 to 939.0
|
36.5 Kcal/day
Interval -266.7 to 459.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Arm A: Control Group
n=12 Participants
These participants will continue to receive their usual care from their primary medical care team.
|
Arm B: Intervention Group
n=14 Participants
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
|
|---|---|---|
|
Exercise
|
-1290 steps/day
Interval -2932.3 to 503.0
|
253.4 steps/day
Interval -903.9 to 1201.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm A: Control Group
n=12 Participants
These participants will continue to receive their usual care from their primary medical care team.
|
Arm B: Intervention Group
n=14 Participants
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
|
|---|---|---|
|
Stress
|
0.5 scores on a scale
Interval -2.0 to 2.0
|
-1.0 scores on a scale
Interval -3.0 to 4.0
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Arm A: Control Group
n=12 Participants
These participants will continue to receive their usual care from their primary medical care team.
|
Arm B: Intervention Group
n=14 Participants
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
|
|---|---|---|
|
Sleep
|
0.0 hours/night
Interval 0.0 to 1.0
|
0.0 hours/night
Interval -1.0 to 0.0
|
Adverse Events
Arm A: Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place