STI.VI. Study: How to Improve Lifestyles in Screening Contexts
Condition: Lifestyle Risk Reduction; Weight Changes, Body; Breast Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Body Weight Changes
Study type: Interventional

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).
    

Detailed description: 
      The study aims to evaluate the effectiveness of intervention models on diet and physical
      activity.

      The study randomizes eligible subjects into four groups: Diet group, Physical Activity group,
      Physical Activity and Diet group and "Usual Care" control group. To each group a specific
      intervention is delivered, consisting of counselling, informative material, and dedicated
      training.

      All participants (with the exception of the control group) receive a basic counselling by
      field experts. Afterwards they are offered an advanced training including more specific and
      detailed actions.

      An information booklet specifically developed for this study is distributed to all
      participants. The booklet contains general information on primary prevention, based on the
      most reliable and updated bibliographic sources on diet and physical exercise.

      Together with the letter of screening invitation eligible men and women receive the proposal
      to participate in the STI.VI. study. Participation to screening is not considered a
      prerequisite for study participation. A direct phone number and e-mail address are given for
      extra information.

      At the time of screening A screening receptionist asks people who received the STI.VI.
      invitation (identified through a flag) whether they are interested in the STI.VI. study and
      therefore refers them to the STI.VI. desk.

      At the STI.VI. desk, trained research assistants give further explanations and additional
      material (patient information sheet, informed consent form and the STI.VI. questionnaire). If
      informed consent is signed, an appointment is fixed for anthropometric measurements and for
      taking blood and saliva samples.

      People are asked to fill in the questionnaire and to hand it back at the time of the blood
      sampling.

      The STI.VI. questionnaire consists of 5 sections (physical activity, dietary habits, smoking
      habits, general health conditions, and general information) in order to collect baseline
      information on lifestyle habits. Type, amount and frequencies of dietary consumptions and
      physical activities are collected. The questionnaire also investigates the perception of
      one's own lifestyle and an motivation towards change.

      In this study phase all participants are randomly allocated to the 4 study groups.

      This is achieved through a permuted block design with block size of 12, 16, and 20 units
      width (W.F. Rosenberger, J. Lachin. Randomization in clinical trials: theory and practice.
      Wiley and sons, 2002, pag. 57). This method allows an almost complete uniform distribution of
      the randomisation groups in every moment of the study; this is necessary in order to simplify
      the subsequent courses management (see below). Participants are told about their group
      allocation at the time of biological sampling / anthropometric measurements, only.

      At baseline appointment.

      Participant subjects undergo anthropometric measurements. The following information are
      collected:

        -  Reproductive and eventual menopause history (women only)

        -  Eventual drug therapy under way,

        -  Height,

        -  Body composition,

        -  Waist circumference

        -  Arterial pressure. Then participants undergo blood drawing. Two types of blood samples
           are drawn: one for immediate biochemical analysis and another to be frozen. The freshly
           blood is used for instantaneous examinations for the following clinic-biochemical
           parameters: Insulin, Glucose, Total Cholesterol, LDL,HDL, Triglycerides, Minerals
           (Sodium, Potassium, Calcium, Iron), IGF-I, Testosterone, 17-ß-Estradiol, SHBG. These
           analyses are made for women invited to mammography screening while for people invited to
           colorectal screening supplemental tests are made also for vitamin D, 25 OH, PRC and high
           sensitive PRC.

      Cryopreserved blood samples are stored in a bio-bank for epigenetic, metabolomics and
      metabonomics analyses. Bio-banking includes a security system and a data base specifically
      implemented for samples storage and traceability.

      About 3 ml of saliva are also collected to investigate variations in genetic and metabolic
      parameters. Saliva samples are cryopreserved with the same modalities as blood samples.

      Immediately after biological sampling / anthropometric measurements a short counselling takes
      place. Trained counsellors answer all eventual questions on the study posed by participants
      and inform them on the next steps. They also deliver to all participants a basic booklet
      containing general information on primary prevention, based on the most reliable and updated
      bibliographic sources on diet and physical exercise (World Cancer Research Fund/American
      Institute for Cancer Research. Food, nutrition, physical activity, and the prevention of
      cancer: a global perspective. Washington, DC: AICR, 2007; WHO, Move for Health, 2002; EU
      Working Group "Sport and Health", EU Physical Activity Guidelines, 2008).

      Follow-up phase

      Two follow-ups are planned:

      • Intermediate, after 8 months since biological sampling / anthropometric measurements (the
      exact date is reckoned calculating 6 months + the average intervention duration ± 2 weeks,
      for managing reasons): it consists of repeating anthropometric measurements and questionnaire
      filling, and counselling.

      All participants are contacted by letter and/or telephone, inviting them to contact the study
      secretariat in order to fix an appointment for repeating anthropometric measurements and
      questionnaire filling; during the follow-up visit trained counsellors verify participants'
      compliance with the provided recommendations, examine eventual encountered difficulties and
      provide support if needed.

      • Final, after 6 months from intermediate follow-up (i.e., after 14 months since biological
      sampling / anthropometric measurements): it consists of repeating anthropometric
      measurements, biological sampling, and questionnaire filling, and counselling.

      All participants are contacted by letter and/or telephone, inviting them to contact the study
      secretariat in order to fix an appointment for repeating once again anthropometric
      measurements, questionnaire filling and also biological sampling.
    

Intervention name(s): Diet group; Physical activity group; Physical activity and diet group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast cancer screening; Colorectal Cancer screening; Primary prevention; Lifestyles; Teachable moment