Lifestyle Risk ReductionSTIVINCT03118882
STI.VI. Study: How to Improve Lifestyles in Screening Contexts
A study testing Diet group, Physical activity group and Physical activity and diet group in people with Lifestyle Risk Reduction and Weight Changes, Body, run by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 49 to 61 years
- Conditions the study is for
- Lifestyle Risk Reduction, Weight Changes, Body, Breast Cancer
- What is being tested?
- Diet group, Physical activity group and Physical activity and diet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,270 participants
- Where
- 1 siteItaly
- Study dates
- May 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 49 to 55-year-old women invited to mammography screening,
- 58 to 61 year-old people (both sexes) invited to colorectal screening
Who cannot join
- psychiatric disorders,
- disabling disease
- life expectancy <6 months
- eating or deambulation disorders
- in physiotherapy at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.C.D.O. Epidemiologia dei Tumori - Azienda Ospedaliera S. Giovanni Battista di Torino
Turin, Piedmont, 10123
About this study
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.
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).
Read the 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.
- Being tested
- Diet group, Physical activity group, Physical activity and diet group
- Keywords
- Breast cancer screening, Colorectal Cancer screening, Primary prevention, Lifestyles, Teachable moment
- Medical subject headings
- Risk Reduction Behavior, Body Weight Changes, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet groupBehavioural
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.
Physical activity groupBehavioural
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 and diet groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet Group | Active comparator | Not described Receives: Behavioral: Diet group |
| Physical activity group | Active comparator | Not described Receives: Behavioral: Physical activity group |
| Physical activity and diet group | Active comparator | Not described Receives: Behavioral: Physical activity and diet group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility outcome
initial participation rate overall and stratified by intervention group, age, and gender;
Measured: 14 months
impact of intervention model
compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;
Measured: 14 months
impact of intervention model
changes in anthropometric measurements
Measured: 14 months
impact of intervention model
comparison of metabolic parameters (insulin, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, IGF-1, testosterone)
Measured: 14 months
impact of intervention model
evaluation of potential genetic and/or metabolic biomarkers in cancer development;
Measured: 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;
Measured: up to 10 years after study end
screening-related indicators
evaluation of breast and colorectal screening outcomes among STI.VI. participants
Measured: up to 10 years after study end
Secondary outcomes (2)
Biobank implementation
number of blood sample and saliva sample cryopreserved at baseline and at final follow up
Measured: up to 10 years after study end
Circulating biomarkers association with breast and colorectal cancer
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.
Measured: up to 10 years after study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study startMay 2010
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lifestyle Risk ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Locale Torino 1
- Responsible party
- Principal investigator, Nereo Segnan, Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
- Investigators
- Nereo Segnan, MD MSc Epi, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118882
- Sponsor's protocol ID
- Pratica 2008.1405 Prot.1362
- Acronym
- STIVI
- Status last verified
- Apr 2017
- First submitted
- 31 Mar 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12729175Robb 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.
PubMed 20950640Anderson 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.
PubMed 23324132Assfalg 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.
PubMed 18230739Steindorf 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.
PubMed 22903273
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03118882
- Acronym / sponsor ID
- STIVI / Pratica 2008.1405 Prot.1362
- Keywords
- Breast cancer screening, Colorectal Cancer screening, Primary prevention, Lifestyles, Teachable moment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica PiemonteUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Locale Torino 1
- Study start
- May 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 49 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 49 to 55-year-old women invited to mammography screening,
- 58 to 61 year-old people (both sexes) invited to colorectal screening
Key exclusion criteria (5 listed)
- psychiatric disorders,
- disabling disease
- life expectancy <6 months
- eating or deambulation disorders
- in physiotherapy at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet groupA 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. | Behavioural | Diet Group |
| Physical activity groupA 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. | Behavioural | Physical activity group |
| Physical activity and diet groupA 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. | Behavioural | Physical activity and diet group |
Primary outcome
feasibility outcome
Time frame: 14 months
initial participation rate overall and stratified by intervention group, age, and gender;
impact of intervention model
Time frame: 14 months
compliance to lifestyle recommendations and their maintenance assessed through the STI.VI. questionnaire;
impact of intervention model
Time frame: 14 months
changes in anthropometric measurements
impact of intervention model
Time frame: 14 months
comparison of metabolic parameters (insulin, glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, IGF-1, testosterone)
impact of intervention model
Time frame: 14 months
evaluation of potential genetic and/or metabolic biomarkers in cancer development;
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;
screening-related indicators
Time frame: up to 10 years after study end
evaluation of breast and colorectal screening outcomes among STI.VI. participants
2 secondary outcomes
Biobank implementation
Time frame: up to 10 years after study end
Circulating biomarkers association with breast and colorectal cancer
Time frame: up to 10 years after study end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Background: PubMed 12729175McBride 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.
- Background: PubMed 20950640Robb 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.
- Background: PubMed 23324132Anderson 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.
- Background: PubMed 18230739Assfalg 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.
- Background: PubMed 22903273Steindorf 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lifestyle Risk Reduction
Not yet recruiting
Culinary And Lifestyle Medicine Education for Cancer Risk Reduction in Survivors of Breast Cancer
Breast Cancer
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
RecruitingObservational study
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
Breast Neoplasms Diagnosis
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Lifestyle Intervention in the Memory Clinics of General and Academic Hospitals Trial
Lifestyle Intervention, Lifestyle Risk Reduction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nereo Segnan, MD MSc Epi principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet group, Physical activity group and Physical activity and diet group in people with Lifestyle Risk Reduction and Weight Changes, Body, run by Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility outcome (time frame: 14 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118882, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.