FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01636258
First received: July 5, 2012
Last updated: May 21, 2014
Last verified: May 2014
Results First Received: October 31, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Prediabetes
Overweight
Interventions: Behavioral: Stress Management
Behavioral: Diet
Behavioral: Exercise
Behavioral: Culinary education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants who were enrolled in study were excluded at baseline laboratory check due to glycated hemoglobin (HgbA1c) value below 5.7%.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Arm A: Control Group     Arm B: Intervention Group  
STARTED     13     14  
COMPLETED     12     14  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Arm A: Control Group     Arm B: Intervention Group     Total  
Number of Participants  
[units: participants]
  13     14     27  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     11     21  
>=65 years     3     3     6  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 9.3     57.7  ± 11.4     55  ± 10.4  
Gender  
[units: participants]
     
Female     13     14     27  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     13     14     27  



  Outcome Measures
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1.  Primary:   Effect of "FRESH" Program on Weight Loss   [ Time Frame: Baseline line and final followup visit (at 8-14 weeks) ]

2.  Secondary:   Diet - Daily Calorie Intake   [ Time Frame: Baseline and final followup visit (at 8-14 weeks) ]

3.  Secondary:   Exercise   [ Time Frame: Baseline and final followup visits (at 8-14 weeks) ]

4.  Secondary:   Stress   [ Time Frame: baseline and followup visit (at 8-14 weeks) ]

5.  Secondary:   Sleep   [ Time Frame: baseline and followup visit (at 8-14 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Adam M. Bernstein MD
Organization: The Cleveland Clinic
phone: 216-448-8538
e-mail: bernsta2@ccf.org


No publications provided


Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01636258     History of Changes
Other Study ID Numbers: 12-340
Study First Received: July 5, 2012
Results First Received: October 31, 2013
Last Updated: May 21, 2014
Health Authority: United States: Institutional Review Board