Clinical trial · Interventional
STI.VI. Study: How to Improve Lifestyles in Screening Contexts
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lifestyle Risk Reduction | — | UNRESOLVED | — |
| Weight Changes, Body | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet group | Behavioral | — | UNRESOLVED |
| Physical activity and diet group | Behavioral | — | UNRESOLVED |
| Physical activity group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Diet Group
- interventionNames
- Behavioral: Diet group
- type
- ACTIVE_COMPARATOR
- label
- Physical activity group
- interventionNames
- Behavioral: Physical activity group
- type
- ACTIVE_COMPARATOR
- label
- Physical activity and diet group
- interventionNames
- Behavioral: Physical activity and diet group
- type
- NO_INTERVENTION
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 49 Years
- Maximum age
- 61 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDMcBride 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
- BACKGROUNDRobb 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
- BACKGROUNDAnderson 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
- BACKGROUNDAssfalg 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
- BACKGROUNDSteindorf 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