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Impact of adapted physical activity on the quality of life of patients with type 2 diabetes

France, Åland islands, 2026
Reference ID
FReSH-50257-en
Producer(s)
Saif;AGHAR
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Jan 24, 2026
Last modified
Jan 24, 2026
Page views
4
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Access policy
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FReSH-50257-draft-en

    Title

    Impact of adapted physical activity on the quality of life of patients with type 2 diabetes

    Abbreviation or Acronym

    ACTI-DIAB

    Country
    Name Country code
    France fr
    Åland islands ax
    Abstract

    This prospective observational study aims to evaluate the impact of a 12-week adapted physical activity program on the quality of life of adult patients with type 2 diabetes. Clinical and biological data, as well as quality of life scores (SF-36), are collected at baseline and at the end of the program in order to analyze changes in HbA1c, physical activity levels, and overall well-being among participants.

    Kind of Data

    ['Clinical data']

    Unit of Analysis

    Individus

    Scope

    Topics
    Topic Vocabulary
    Addiction medicine health theme
    Infectious disease medicine health theme
    Diabetes mellitus, type unspecified cim-11
    Type 2 diabetes mellitus cim-11
    Environmental determinants health determinant
    Healthcare system determinants health determinant
    Keywords
    diabetes type 2 APA

    Coverage

    Geographic Coverage

    ['Grand Est','Nouvelle-Aquitaine']

    Universe

    {
    "level_sex_clusion_I": [
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D005260"
    },
    "value": "Female"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D008297"
    },
    "value": "Male"
    }
    ],
    "level_age_clusion_I": [
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D000293"
    },
    "value": "Adolescent (13 to 18 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D055815"
    },
    "value": "Young Adult (19 to 24 years)"
    },
    {
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "D008875"
    },
    "value": "Middle Aged (45 to 64 years)"
    }
    ],
    "level_type_clusion_I": "General population",
    "level_type_clusion_other": "",
    "clusion_I": "Adults aged 18 to 70 years old Confirmed diagnosis of type 2 diabetes for at least 6 months\r\n\r\nHbA1c between 6.5% and 9.5% at inclusion Medical ability to perform appropriate physical activity Free, informed, and signed consent Affiliation with a social security system",
    "clusion_E": "Type 1 diabetes or gestational diabetes Severe uncontrolled diabetes complications (cardiac, renal, neurological) Medical contraindication to physical activity Simultaneous participation in another interventional study\r\n\r\nPregnancy or breastfeeding Inability to understand the study information or comply with the protocol"
    }

    Producers and sponsors

    Primary investigators
    Name
    Saif;AGHAR
    Producers
    Name Role
    ARCELOR LUXEMBOURG sponsor
    Funding Agency/Sponsor
    Name
    AG2R AGIRC-ARRCO (UGRR)
    Other Identifications/Acknowledgments
    Name
    Sarah;JONSHON
    AEPEI (ASSOCIATION POUR L'ETUDE ET LA PREVENTION DES L'ENDOCARDITE INFECTIEUSE)

    Study authorization

    Agency
    Agency name
    ANSM
    Other

    Sampling

    Sample frame

    Unit Type

    ['Through independent healthcare practitioners','Other']

    Sampling Procedure

    ['{"concept":{"vocab":"CESSDA","vocabURI":"TotalUniverseCompleteEnumeration"},"value":"Complete enumeration (including consecutive recruitment)"}']

    Survey instrument

    Questionnaires

    The aggregated, anonymized, and standardized data will be made available to academic partners and competent authorities via a secure platform or CSV/PDF files. Access is restricted to authorized users after authentication and confidentiality agreement, and reports are provided at the end of each analysis phase or upon request, in compliance with regulations.

    Methodology notes

    Interventional Study

    Data collection

    Dates of Data Collection
    Start End
    2026-05-12 2026-08-30
    Frequency of Data Collection

    monthly

    Mode of data collection
    • {"concept":{"vocab":"CESSDA","vocabURI":"Interview"},"value":"Interview with the participant (including clinical)"}
    • {"concept":{"vocab":"CESSDA","vocabURI":"Recording"},"value":"Recording (audio, video, electrophysiological, imaging)"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    BMI (Body Mass Index, kg/m²)
    Study activities
    Type
    secondary evaluation
    Description
    Fasting blood glucose (mmol/L) Type: Biological/clinical Description: Standardized blood sample taken at the start and end of the program to measure metabolic control of diabetes. Waist circumference (cm) Type: Anthropometric/indicator of abdominal fat mass Description: Standardized measurement to assess body fat distribution. SF-36 quality of life score Type: Psychological / self-reported Description: Validated questionnaire to assess participants' physical and mental well-being at baseline and at the end of the study.

    Quality standards

    Quality standards
    Standard
    ['ICD-10: for coding pathologies and comorbidities.','LOINC: for the standardization of biological analyses and laboratory results.']
    Other quality statement

    ['Internal SOPs (Standard Operating Procedures) for the collection and entry of clinical and biological data.','Quality control and double entry into the secure database, with data verification and validation prior to analysis']

    Access policy

    Location of Data Collection

    The data is stored securely in a centralized electronic database, hosted on servers that comply with security and confidentiality standards (GDPR). Physical and electronic access is strictly reserved for authorized members of the research team.

    Completeness of Study Stored

    All data files are checked to ensure that all required variables are complete, that there are no duplicates, and that the records are consistent. Missing data is flagged and documented, and only complete and validated information is used for statistical analysis.

    Data Access

    Access authority
    Name Email
    Assistance;FRESH assitanceIHdev@impactgroup.tech
    Confidentiality
    Confidentiality declaration text
    All users authorized to access data must sign a confidentiality agreement specifying their obligations regarding protection, non-disclosure, and compliance with regulations (GDPR, good clinical practices). This agreement governs the use, storage, and dissemination of data, ensuring the security and confidentiality of participants' information.
    Access conditions

    Access to data is restricted to authorized investigators and personnel via secure login credentials. Any use of the data requires compliance with confidentiality protocols, the GDPR, and, where applicable, prior approval from the scientific committee or study sponsor.

    Citation requirements

    OBLIIII

    Deposit requirements

    The results and analyses from the study must be sent to the sponsor and, where applicable, to the competent authorities in accordance with the deadlines set out in the protocol. Any external publication or dissemination requires the prior consent of the sponsor and compliance with the conditions of confidentiality and data ownership.

    Availability Status

    {"extLink":{"title":"COAR","uri":"http://purl.org/coar/access_right/c_abf2"},"value":"Open access"}

    Special Permissions
    Indicate if special permissions are required to access a resource Special permissions description
    Yes https://pdad.hostnet.solutions
    Restrictions

    Access to data is restricted to authorized investigators and personnel via secure login credentials. Any use of the data requires compliance with confidentiality protocols, the GDPR, and, where applicable, prior approval from the scientific committee or study sponsor.

    Notes

    www.data-gouv.com

    Contacts

    Contacts
    Name Email
    Saif;AGHAR sagefemme8@impact-dev.tn
    Sarah;JONSHON sarah.jonhson@impactgroup.tech

    Metadata production

    DDI Document ID

    FReSH-50257-draft-en

    Producers
    Name Affiliation
    Walma GHARBI INSERM TRANSFERT
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