Status:
COMPLETED
Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
Almased Wellness GmbH
Conditions:
Obesity
Metabolic Syndrome
Eligibility:
All Genders
34-65 years
Phase:
NA
Brief Summary
Eligible overweight and obese persons will be randomized to one of three controlled groups: 1 group of participants is treated by health education for life style intervention only. The other 2 groups ...
Detailed Description
Obese and adipose participants are randomized to three intervention groups. During the first six weeks of the program, the subjects assigned to the substitutional diet group (SD-G) were instructed to ...
Eligibility Criteria
Inclusion
- Eligible participants must have overweight with a BMI between 27,5 and 35 kg/m²
- The participants must be able to participate in a physical activity program
- The participants must be willing to participate in the program for 1 year
- Written informed consent must be given to accept randomization to either of the intervention groups
Exclusion
- Participants who do not meet all entry criteria
- BMI \> 35,0 kg / m²
- Performance capacity \< 75 w for 2 min
- Subjects younger than 35 yrs (with reference age at 1st Jan 2002: 34.5 yrs) or older than 65 yrs (with reference age at 1st 2002: 65.5 yrs)
- Absolute or relative contraindications to exercise testing of the ACSM
- Persons unable or with restrictions to participate in a regular physical activity program because of any disease (e.g. history of CHD, arrhythmia, valvular heart disease, arthritis of major joints)
- Severe hypertension systolic BP of \> 200 mm Hg and or diastolic BP of \> 105 mm Hg at rest
- Persons with established insulin dependent diabetes mellitus (IDDM)
- Persons with a disease of the liver or the kidneys prohibiting high protein intake
- Persons with a disease of the thyroid gland or taking thyroid hormones
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2001
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00356785
Start Date
January 1 2001
End Date
December 1 2001
Last Update
July 26 2006
Active Locations (1)
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1
University Hospital, Department for Rehabilitation, Prevention and Sports Medicine
Freiburg im Breisgau, Germany, 79106