Family Healthy Living Early Intervention Program (EIP)

October 4, 2018 updated by: Patti-Jean Naylor, University of Victoria

Family-based, Healthy Living Intervention for Children With Overweight and Obesity and Their Families

The Childhood Healthy Weights Early Intervention Program (EIP) is a family-based pilot program that will promote healthy lifestyle practices for families whose children are off the healthy weight trajectory (e.g., BMI ≥ 85th percentile for age and sex) that do not need the intensive services of medically supervised programs. It is a lifestyle behaviour approach for promoting healthy weights in children. The EIP program consists of 10 weekly intervention sessions (1.5 hours per session) followed by 4 maintenance sessions and is age specific (age 8-12). During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. The program will be integrated and aligned with existing BC-specific childhood healthy weights programs (e.g. the HealthLinkBC Eating and Activity Program for Kids). The EIP pilot will run from October-December 2018 with 8 child programs (age 8-12). Participants who do not qualify for this program (e.g., BMI ≤ 85th percentile for age and sex) will be offered a 10 week online program which is similar in educational content as the EIP program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Patti-Jean Naylor, PhD
  • Phone Number: 250-721-8373
  • Email: pjnaylor@uvic.ca

Study Locations

  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V3J 1L6
      • Campbell River, British Columbia, Canada, V9W8C8
        • Recruiting
        • Strathcona Gardens Recreation Complex
        • Contact:
      • Chilliwack, British Columbia, Canada, V2P2P8
      • Kelowna, British Columbia, Canada, V1X2M9
      • North Cowichan, British Columbia, Canada, V9L2E6
      • Prince George, British Columbia, Canada
      • Surrey, British Columbia, Canada, V3S7S6
      • Surrey, British Columbia, Canada, V4N0E9
        • Recruiting
        • Surrey Sport & Leisure Complex
        • Contact:
      • Vancouver, British Columbia, Canada, V5Y2Z5
      • Victoria, British Columbia, Canada, V9B1J1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child with BMI ≥ 85th percentile for age and sex
  • Child is accompanied by a parent or legal guardian
  • At least one member of the family have to be able to speak and read English
  • Family agrees to attend group meetings over 10 weeks

Exclusion Criteria:

  • Child unavailable to attend group weekly sessions
  • Parent or guardian unavailable to attend group weekly sessions
  • Participating child or parent, according to parent report, has medical condition contraindicating mild energy restriction or moderate physical activity, and medical clearance was not obtained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Family Healthy Living Intervention
Children aged 8-12 and at least one caregiver will meet for 10 weekly face-to-face and online intervention sessions (1.5 hours per session). Four biweekly maintenance sessions will follow the main program.
Behavioral: Family Healthy Living
Children aged 8-12 and at least one caregiver will meet for 10 weekly intervention sessions (1.5 hours per session), and 4 extra sessions to be chosen by families and intervention Leaders. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. Four biweekly maintenance sessions will follow the main program.
NO_INTERVENTION: Wait-list control group
Children aged 8-12 will be randomly assigned to the wait-list control group until after the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in BMI calculated from measures of height and weight
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Measures of height and weight will be obtained from all children. BMI will be calculated as weight (kilograms) divided by height (meters) squared, adjusted for child age and sex.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in BMI z-score calculated from measures of height and weight
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Measures of height and weight will be obtained from all children, BMI z-scores (standard deviation) will be calculated.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Self-reported child usual physical activity engagement will be assessed by PAQ-C 7-day physical activity recall
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Motivation and Confidence assessed by the Canadian Assessment of Physical Literacy (CAPL-2) Physical Activity Motivation and Confidence subscale
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. The Motivation and Confidence sub-scale of CAPL-2 assesses physical activity predilection and adequacy, perceived physical activity intrinsic motivation and competence
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. The PACE Adolescent Psychosocial Measures assesses physical activity, confidence, and family support
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. The PACE Adolescent Psychosocial Measures assesses sedentary habits, confidence, and family support
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Fundamental Movement Skills (FMS) assessed by the Canadian Agility and Movement Skill Assessment (CAMSA)
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
CAMSA is the FMS course from the Canadian Assessment of Physical Literacy (CAPL-2) that assesses two-foot jumping, sliding, catch, throw, skip, one-foot hop, and kick. Children will observe two demonstrations, will complete two trials, and two timed and scored trials.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Dietary Behaviours assessed by the LiGHT questionnaire (7-day recall questions retrieved from CDC BRFSS surveys)
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Dietary behaviours such as fruits, vegetables, fruit juice, soda, fruit-flavored beverages, and pastries intake will be assessed by the 7-day dietary recall
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Healthy Eating Outcome Expectations assessed by the Power Play! Survey.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Knowledge or ideas about what will happen when regularly consuming fruits and vegetables.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Self-efficacy to increase fruit and vegetable intake, and to reduce the intake of sugary beverages and sweet/salty snack foods will be assessed.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Motivation for eating fruits and vegetables will be assessed. Motivation for limiting sweet/salty snack foods and sugary drinks will also be assessed.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Assesses child's ability to prepare and cook food
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Self-esteem assessed by the Project EAT survey
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Self-esteem will be assessed by the Project EAT survey
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Gratitude assessed by the Gratitude Adjective Checklist
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Changes in Gratitude assessed using the Gratitude Adjective Checklist
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Self-compassion by the Self-compassion Scale Short Form
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Changes in Gratitude assessed using the Self-compassion Scale Short Form
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Sleep Habits assessed by the FLASHE questionnaire
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Child questionnaire. Usual hours of sleep will be self-reported by the child
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The FLASHES-EAT survey assess how parents communicate with their children regarding food and dietary habits and how they organize and monitor the home food environment.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The CANPOWER questionnaire assesses whether or not parents encourage their child to participate in healthy lifestyle behaviors (eating fruits and vegetables)
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. This questionnaire assess each parent's specific behavioral constructs (affective attitude, instrumental attitude) in regards to supporting their child's healthy eating behaviors.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Structure of the Home Food Environment assessed by the Fruit and Vegetable At Home Survey For Parents.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The Fruit and Vegetable At Home Survey For Parents assess the availability and accessibility of fruits and vegetables within the home.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent's Personal Dietary Behaviours are assessed by the FLASHE questionnaire.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The FLASHE questionnaire assess parents' fruit and vegetable intake in addition to their consumption of food away from the home (e.g. fast-food restaurants, work cafeteria).
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Food Preparation Self-efficacy assessed with two questions drawn from the FLASHES-EAT survey.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The questions drawn from the FLASHES-EAT survey assess parents' confidence level with preparing a variety of fruits and vegetables as well as their level of confidence preparing family meals with their children.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Behavioral Regulation of Supporting Child's Healthy Eating assessed by the Action Control of Parent Support Behaviour
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child's healthy eating behaviors.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Habits assessed by the automaticity subscale of Self-Report Index of Habit.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The Self-Report Index of Habit assess whether or not parents believe that preparing and eating healthy meals is something their family does habitually.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Healthy Eating Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. These questions assess how parents view their own and their family's dietary behaviors and food choices.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. Changes in Parent Physical Activity Support will be assessed by the ParticipACTION 24hr Guidelines Survey
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Behavioral Regulation of Supporting Child's Physical Activity assessed by the Action Control of Parent Support Behaviour
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child's physical activity participation.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Habit assessed by the automaticity subscale of the Self-Report Index of Habit
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. The Self-Report Index of Habit assess whether or not parents believe that participating in physical activity is something their family does habitually.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Physical Activity Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. These questions assess how parents view their own and their family's physical activity participation.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Parent Support for Child Sleep Habits assessed by the ParticipACTION 24hr Guidelines Survey
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. Changes in Parent Support for Child Sleep Habits will be assessed by the ParticipACTION 24hr Guidelines Survey
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Changes in Child Quality of Life assessed by the Pediatric Quality of Life Inventory
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Parent questionnaire. Changes in Child Quality of Life will be assessed by the Pediatric Quality of Life Inventory
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Process Evaluation of the EIP
Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Evaluate the reach, implementation, and sustainability of the EIP. Examine if the EIP is reaching a broad demographic, if families and staff are satisfied with the EIP, if the EIP is being implemented as intended across the pilot sites and to explore the facilitators and barriers to implementation.
Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Victoria

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Childhood Obesity Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Karen Strange, PhD, Childhood Obesity Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BC18-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will only be share with co-investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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