STI.VI. Study: How to Improve Lifestyles in Screening Contexts (STIVI)
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|ClinicalTrials.gov Identifier: NCT03118882|
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : April 19, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Lifestyle Risk Reduction Weight Changes, Body Breast Cancer Colorectal Cancer||Behavioral: Diet group Behavioral: Physical activity group Behavioral: Physical activity and diet group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot RCT on Lifestyles Impact on Health Outcomes in the General Population Invited to Mammography and Colorectal Cancer Screening Programmes. (STI.li di VI.ta - Lifestyles) STI.VI.|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||June 2014|
|Active Comparator: Diet Group||
Behavioral: Diet group
A meeting where an expert illustrates the scientific basis of a proper diet. Moreover, clear and practical indications for dietary habits improvement and for suggested food purchase are provided. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module:hree theoretical and practical cooking meetings (total of 10 hours) held by cooks with an expertise in natural cuisine and by trained dieticians.
|Active Comparator: Physical activity group||
Behavioral: Physical activity group
A meeting where an expert illustrates the benefits of a constant PA. Moreover, indications are given on sport opportunities and walking groups in the city organised by public authorities. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module: three theoretical and practical lessons (total of 10 hours) held by expert physical trainers.
|Active Comparator: Physical activity and diet group||
Behavioral: Physical activity and diet group
A meeting where the indications given to the previous groups are presented simultaneously. Particular attention is paid to the interaction between the two activities. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module: four theoretical and practical meetings (total of 12 hours), two lessons focus on diet and two on PA.
|No Intervention: Control group|
- feasibility outcome [ Time Frame: 14 months ]initial participation rate overall and stratified by intervention group, age, and gender;
- impact of intervention model [ Time Frame: 14 months ]compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;
- impact of intervention model [ Time Frame: 14 months ]changes in anthropometric measurements
- impact of intervention model [ Time Frame: 14 months ]comparison of metabolic parameters (insulin, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, IGF-1, testosterone)
- impact of intervention model [ Time Frame: 14 months ]evaluation of potential genetic and/or metabolic biomarkers in cancer development;
- screening-related indicators [ Time Frame: up to 10 years after study end ]screening participation rate in subjects enrolled in the STI.VI. study and, viceversa, STI.VI. participation rate in screened subjects;
- screening-related indicators [ Time Frame: up to 10 years after study end ]evaluation of breast and colorectal screening outcomes among STI.VI. participants
- Biobank implementation [ Time Frame: up to 10 years after study end ]number of blood sample and saliva sample cryopreserved at baseline and at final follow up
- Circulating biomarkers association with breast and colorectal cancer [ Time Frame: up to 10 years after study end ]investigate whether selected circulating miRNAs previously found associated to brast and colorectal risk are significantly altered in the plasma of cancer patients compared to matched healthy controls and if they satisfy pre-specified true- and false positive rates that are considered minimally acceptable in the screening setting.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118882
|S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino|
|Torino, Piedmont, Italy, 10123|
|Principal Investigator:||Nereo Segnan, MD MSc Epi||Director|