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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
Sponsor:
Collaborator:
Azienda Sanitaria Locale Torino 1
Information provided by (Responsible Party):
Nereo Segnan, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. feasibility outcome [ Time Frame: 14 months ]
    initial participation rate overall and stratified by intervention group, age, and gender;

  2. impact of intervention model [ Time Frame: 14 months ]
    compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;

  3. impact of intervention model [ Time Frame: 14 months ]
    changes in anthropometric measurements

  4. impact of intervention model [ Time Frame: 14 months ]
    comparison of metabolic parameters (insulin, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, IGF-1, testosterone)

  5. impact of intervention model [ Time Frame: 14 months ]
    evaluation of potential genetic and/or metabolic biomarkers in cancer development;

  6. 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;

  7. screening-related indicators [ Time Frame: up to 10 years after study end ]
    evaluation of breast and colorectal screening outcomes among STI.VI. participants


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 49 to 55-year-old women invited to mammography screening,
  • 58 to 61 year-old people (both sexes) invited to colorectal screening

Exclusion Criteria:

  • psychiatric disorders,
  • disabling disease
  • life expectancy <6 months
  • eating or deambulation disorders
  • in physiotherapy at the time of recruitment.

Information from the National Library of Medicine

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


Locations
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Italy
S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino
Torino, Piedmont, Italy, 10123
Sponsors and Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Azienda Sanitaria Locale Torino 1
Investigators
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Principal Investigator: Nereo Segnan, MD MSc Epi Director
Additional Information:
Publications:

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Responsible Party: Nereo Segnan, Director, S.C. Epidemiologia, Screening e Registro Tumori Centre for Cancer Prevention, Principal investigator, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
ClinicalTrials.gov Identifier: NCT03118882    
Other Study ID Numbers: Pratica 2008.1405 Prot.1362
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nereo Segnan, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte:
Breast cancer screening
Colorectal Cancer screening
Primary prevention
Lifestyles
Teachable moment
Additional relevant MeSH terms:
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Colorectal Neoplasms
Body Weight Changes
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Body Weight