FRESH-PEF20903-en
Follow-up of the participants to an intervention controlled trial for the primary prevention of type-2 diabetes mellitus and metabolic syndrome on Reunion Island
REDIA-prev1 Cohort
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']
Individuals
| Topic | Vocabulary |
|---|---|
| Endocrinology | health theme |
| Type 2 diabetes mellitus | cim-11 |
| Behavioral determinants | health determinant |
| Behavioral determinants: Eating habits | health determinant |
['La Réunion']
{
"level_sex_clusion_I": [
{
"value": "Male",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
}
},
{
"value": "Female",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
}
}
],
"level_age_clusion_I": [
{
"value": "Young Adult (19 to 24 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
}
},
{
"value": "Adult (25 to 44 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
}
}
],
"level_type_clusion_I": [
"General population"
],
"level_type_clusion_other": "",
"clusion_I": "The target population eligible to the lifestyle intervention trial was composed of men and women (non-pregnant), aged 18-40, with no serious illness (e.g., diabetes, cardiovascular disease, cancer) nor disability (incompatible with physical activity practice), living in the studied districts, and screened at home as high-risk subjects. This high-risk status was based on a combination of T2DM risk factors: overall obesity (BMI >= 30 kg\/m²), or central adiposity (waist circumference >= 100 cm for men, >= 90 cm for women), or overweight status (BMI between 25 and 30 kg\/m²) associated with at least one other T2DM risk factor . High blood pressure treated or detected (>= 140\/90 mm Hg), elevated glycated hemoglobin (HbA1c between 5.5% and 6.0%), family history of diabetes at first degree, and for women, having a child weighting more than 4 kg at birth and \/or an history of gestational diabetes. Screened subjects without high-risk status were thus not obese (and if overweight with no other T2DM risk factors from those listed above). These collateral persons had been included in the follow-up process besides the high-risk subjects, but they did not participate to the long-term effectiveness evaluation analysis (primary objective of this research). All subjects were screened as non-diabetic based on glycated hemoglobin (HbA1c) measure < 6.0%",
"clusion_E": ""
}
| Name |
|---|
| François;FAVIER |
| Adrian;FIANU |
| Name | Role |
|---|---|
| INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) | sponsor |
| Name |
|---|
| AGENCE NATIONALE DE LA RECHERCHE (ANR) |
| CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION |
| INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) |
| SANTE PUBLIQUE FRANCE |
| Name |
|---|
| Research team: Team EQUITY from the CERPOP (UMR1295, joint research unit INSERM-Université Paul Sabatier), at Toulouse |
['Population database for statistical purposes']
['{"concept":{"vocabURI":"Nonprobability.Purposive","vocab":"CESSDA"},"value":"Non-probability: Purposive or \"judgement\" sampling"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2001-01-01 | 2011-01-01 |
| Standard |
|---|
| ['BMI: body mass index WHO cut-off for adults. Items of the physical activity questionnaire of Baecke et al. Am J Clin Nutr 1982. Food consumption: estimation of food servings photo album INSERM E3N team. PCS (professions and professional categories): INSEE nomenclature.'] |
['Recalling of subjects for follow-up visits, information on personal data use. - Monitoring by a clinical research associate selected by the sponsor: after the first subject’s inclusion, regularly according to the follow-up implementation and the observed protocol\'s deviations, at the end of the study. - Audit / inspection: at each step of the study and until 15 years after study completion. A inter CIC\'s Audit was conducted by the INSERM Institut thématique Santé Publique Pôle Recherche Clinique in 2011 November. - Use of a consistency query: at the time of data entry. - Missing data management: when necessary, use of subject contact for data completion in the closest timeframe. - Data management implementation before statistical analysis.']
{"value":"To be defined","extLink":[]}
| Name | |
|---|---|
| François;FAVIER | francois.favier@chu-reunion.fr |
| Adrian;FIANU | adrian.fianu@chu-reunion.fr |
FRESH-PEF20903-en
| Name | Affiliation |
|---|---|
| Adrian FIANU | CENTRE HOSPITALIER UNIVERSITAIRE DE LA REUNION |