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

NCT03118882 | Completed

• 1 other identifier: Pratica 2008.1405 Prot.1362
• Study Type: interventional
• Target: 1,270
• Locations: 1 country
• Sites: 1

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).

Conditions

Lifestyle Risk Reduction; Weight Changes, Body; Breast Cancer; Colorectal Cancer

Keywords

Breast cancer screening; Colorectal Cancer screening; Primary prevention; Lifestyles; Teachable moment

Outcome Measures

Primary Outcomes (7)

• feasibility outcome

  initial participation rate overall and stratified by intervention group, age, and gender;

  14 months

• impact of intervention model

  compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;

  14 months

• impact of intervention model

  changes in anthropometric measurements

  14 months

• impact of intervention model

  comparison of metabolic parameters (insulin, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, IGF-1, testosterone)

  14 months

• impact of intervention model

  evaluation of potential genetic and/or metabolic biomarkers in cancer development;

  14 months

• screening-related indicators

  screening participation rate in subjects enrolled in the STI.VI. study and, viceversa, STI.VI. participation rate in screened subjects;

  up to 10 years after study end

• screening-related indicators

  evaluation of breast and colorectal screening outcomes among STI.VI. participants

  up to 10 years after study end

Secondary Outcomes (2)

• Biobank implementation

  up to 10 years after study end

• Circulating biomarkers association with breast and colorectal cancer

  up to 10 years after study end

Study Arms (4)

Diet Group

ACTIVE COMPARATOR

Behavioral: Diet group

Physical activity group

ACTIVE COMPARATOR

Behavioral: Physical activity group

Physical activity and diet group

ACTIVE COMPARATOR

Behavioral: Physical activity and diet group

Control group

NO INTERVENTION

Interventions

Diet group BEHAVIORAL

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.

Diet Group

Physical activity group BEHAVIORAL

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.

Physical activity group

Physical activity and diet group BEHAVIORAL

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.

Physical activity and diet group

Eligibility Criteria

• Age: 49 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: lead
• Azienda Sanitaria Locale Torino 1: collaborator

Study Sites (1)

S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino

Turin, Piedmont, 10123, Italy

Location

Related Publications (5)

• McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003 Apr;18(2):156-70. doi: 10.1093/her/18.2.156.

  PMID: 12729175 BACKGROUND

• Robb KA, Power E, Kralj-Hans I, Atkin WS, Wardle J. The impact of individually-tailored lifestyle advice in the colorectal cancer screening context: a randomised pilot study in North-West London. Prev Med. 2010 Dec;51(6):505-8. doi: 10.1016/j.ypmed.2010.10.002. Epub 2010 Oct 13.

  PMID: 20950640 BACKGROUND

• Anderson AS, Mackison D, Boath C, Steele R. Promoting changes in diet and physical activity in breast and colorectal cancer screening settings: an unexplored opportunity for endorsing healthy behaviors. Cancer Prev Res (Phila). 2013 Mar;6(3):165-72. doi: 10.1158/1940-6207.CAPR-12-0385. Epub 2013 Jan 16.

  PMID: 23324132 BACKGROUND

• Assfalg M, Bertini I, Colangiuli D, Luchinat C, Schafer H, Schutz B, Spraul M. Evidence of different metabolic phenotypes in humans. Proc Natl Acad Sci U S A. 2008 Feb 5;105(5):1420-4. doi: 10.1073/pnas.0705685105. Epub 2008 Jan 29.

  PMID: 18230739 BACKGROUND

• Steindorf K, Ritte R, Eomois PP, Lukanova A, Tjonneland A, Johnsen NF, Overvad K, Ostergaard JN, Clavel-Chapelon F, Fournier A, Dossus L, Teucher B, Rohrmann S, Boeing H, Wientzek A, Trichopoulou A, Karapetyan T, Trichopoulos D, Masala G, Berrino F, Mattiello A, Tumino R, Ricceri F, Quiros JR, Travier N, Sanchez MJ, Navarro C, Ardanaz E, Amiano P, Bueno-de-Mesquita HB, van Duijnhoven F, Monninkhof E, May AM, Khaw KT, Wareham N, Key TJ, Travis RC, Borch KB, Sund M, Andersson A, Fedirko V, Rinaldi S, Romieu I, Wahrendorf J, Riboli E, Kaaks R. Physical activity and risk of breast cancer overall and by hormone receptor status: the European prospective investigation into cancer and nutrition. Int J Cancer. 2013 Apr 1;132(7):1667-78. doi: 10.1002/ijc.27778. Epub 2012 Sep 14.

  PMID: 22903273 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Risk Reduction Behavior; Body Weight Changes; Breast Neoplasms; Colorectal Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nereo Segnan, MD MSc Epi

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, S.C. Epidemiologia, Screening e Registro Tumori Centre for Cancer Prevention, Principal investigator

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 18, 2017
• Study Start: May 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)