Weight Changes, Body clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03118882 Completed - Breast Cancer Clinical Trials

STI.VI. Study: How to Improve Lifestyles in Screening Contexts

STIVI

Start date: May 2010
Phase: N/A
Study type: Interventional

The main study objective is to determine the feasibility and impact (effectiveness) of intervention models for lifestyle changing (diet and physical activity) on health outcomes. Women 50 to 54-year-old attending the local breast cancer screening and 58-year-old people (both sexes) undergoing colorectal cancer screening are invited to participate in the study. Compliers are randomized into 3 intervention groups (Diet, Physical Activity, and Physical Activity and Diet) and into the 'usual care' Control group. Biological sampling (blood and saliva) is collected from all participants. All participants undergo also anthropometric measurements and fill in a self-administered validated questionnaire on their dietary and physical activity habits. All enrolled subjects receive a booklet with basic information about diet and physical activity. Subjects randomized to the 3 intervention groups are also offered one theoretical and three training courses. The courses are specifically designed for the different interventions proposed and aimed at reinforcing the educational counseling and at supporting behavioral changes. Follow-up is performed at 8 (intermediate follow-up) and 12-14 (final follow-up) months for repeating anthropometric measurements and questionnaire filling and blood sampling (at the final one).