Prevention Strategies for Adolescents at Risk of Diabetes
PRE-STARt
1 other identifier
observational
634
1 country
1
Brief Summary
The primary aim of PRE-STARt Phase 1 is to pragmatically evaluate and refine a risk assessment tool to identify those children with chronic disease risk factors (including Type 2 Diabetes).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 15, 2019
January 1, 2019
1.2 years
September 7, 2015
January 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic disease risk factor - Body mass index (BMI)
Height and weight will be measured to calculated BMI
12 months
Secondary Outcomes (8)
Chronic disease risk factor - waist circumference
12 months
Chronic disease risk factor - blood pressure
12 months
Chronic disease risk factor - glycated haemoglobin (HbA1c)
12 months
Chronic disease risk factor - high density lipoprotein cholesterol
12 months
Chronic disease risk factor - glucose
12 months
- +3 more secondary outcomes
Other Outcomes (1)
Risk tool refinement
18 months
Study Arms (1)
UK (Lead Site)
Data will be collected from 100 adolescents from each participating site providing clinical data for 500 adolescents providing a cross-sectional cohort from each of the following countries: UK (Lead Site) Germany Portugal Greece Spain (Basque Country)
Interventions
Eligibility Criteria
Boys and girls who are between 12 and 14 years of age who do not have an existing diagnosis of type 1 or type 2 diabetes.
You may qualify if:
- Young people aged between 12-14 years of age
- be willing and able to give assent
- have obtained written parent/guardian consent.
You may not qualify if:
- are outside the age range of interest (i.e. aged less than 12 years or greater than 14 years of age)
- do not have parental consent or do not give assent
- have an existing diagnosis of type 1 or type 2 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospitals, Leicesterlead
- University of Leicestercollaborator
- Associacao Protectora dos Diabeticos de Portugalcollaborator
- The Algarve Regional Health Administrationcollaborator
- University of Leipzigcollaborator
- Technische Universität Dresdencollaborator
- Alexander Technological Educational Institute, Thessaloniki, Greececollaborator
- Diabetes Centre of Paediatrics P&Acollaborator
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"collaborator
- Primary Care Centre Egia, San Sebastian, Spaincollaborator
- Basque Government Department of Public Healthcollaborator
- Health Department of the Alto/Bajo Debacollaborator
Study Sites (1)
University Hospitals of Leicester
Leicester, LE4 5pW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie J Davies, MD
University Hospitals, Leicester
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2015
First Posted
September 9, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 15, 2019
Record last verified: 2019-01