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

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

Interventions

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.

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.

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.

Sponsors & Collaborators

• Azienda Sanitaria Locale Torino 1

  collaborator UNKNOWN

• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

  lead OTHER

Principal Investigators

• Nereo Segnan, MD MSc Epi · Director

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

49 Years

Max Age

61 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2014-01-31

Completion

2014-06-30

Countries

• Italy

Study Locations