Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention. (NCT00356785) | Clinical Trial Compass
CompletedNot Applicable
Changes in Body Composition and Metabolic Risk Parameters by Life Style Intervention.
Germany90 participantsStarted 2001-01
Plain-language 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 will be included in a dietary program with an individually dosed food supplement (Almased®) for an initial weight reduction for a period of 6 weeks. The following 18 weeks represent the most important phase of weight loss and attitude, the participants take part in 2 different interventions according to their randomization. One group will continue the dietary program, one group will try to achieve and maintain weight reduction by continuing the initial dietary program together with an additional physical activity program. For all intervention groups the following 6 months aim at a further stabilization of weight and attitude, now without defined guidelines of intervention but with the intention to continue the so far practiced change in life style. All participants will be supplied with adequate information and material concerning the desired change in life style.
Who can participate
Age range
34 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.