ITMO public health
Last update : 07/27/2018 | Version : 4 | ID : 20903
| General | |
| Identification | |
| Detailed name | 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 |
| Sign or acronym | REDIA-prev1 Cohort |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL : 01/08/2001 ; CPP SOOM III : 2010/56 ; ID RCB : 2010-A00432-37 ; AFSSAPS : B100595-70 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Pathology (details) | Type-2 diabetes mellitus risk factors, metabolic syndrom |
| Health determinants |
Lifestyle and behavior Nutrition |
| Keywords | adiposity, lifestyle intervention, vulnerable population, physical activity, glycemic status, quasi-experimentation, diet, community approach, primary prevention, post-trial follow-up study, long-term effectiveness, transferability. |
| Scientific investigator(s) (Contact) | |
| Name of the director | FIANU |
| Surname | Adrian |
| Address | CIC-EC de la Réunion CHU Saint-Pierre BP350 97448 SAINT PIERRE Cedex |
| Phone | + 33 (0)2 62 35 90 00 |
| adrian.fianu@chu-reunion.fr | |
| Unit | CENTRE D'INVESTIGATION CLINIQUE - ÉPIDÉMIOLOGIE CLINIQUE DE LA RÉUNION (CIC 1410) INSERM / CHU |
| Organization | CHU de la Réunion |
| Name of the director | FAVIER |
| Surname | François |
| Address | CIC-EC de la Réunion CHU Saint-Pierre BP350 97448 SAINT PIERRE Cedex |
| Phone | + 33 (0)2 62 35 90 00 |
| francois.favier@chu-reunion.fr | |
| Unit | CENTRE D'INVESTIGATION CLINIQUE - ÉPIDÉMIOLOGIE CLINIQUE DE LA RÉUNION (CIC 1410) INSERM / CHU |
| Organization | CHU de la Réunion |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Research team: Team 5 "Cancer and chronic diseases: social inequalities in health, primary and secondary care access" from UMR1027, joint research unit INSERM-Université Paul Sabatier, at Toulouse |
| Funding | |
| Funding status |
Public |
| Details | INSERM, CHR, INPES. The work focused on the transferability analysis of the REDIA-prev1 intervention was supported by the National Agency for Research (ANR-11-INEG-0003 "EVALISS"), the Reunion CHU and CIC-EC 1410. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| Labelling and database evaluation | A inter CIC's Audit was conducted by the INSERM Institut thématique Santé Publique Pôle Recherche Clinique in 2011 November. |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A population file |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at group level (clusters) |
| Additional information regarding sample selection. | At inclusion: non-probabilist sampling of subjects screened at home. For high-risk subjects: selection by restriction of eligibility. At follow-up: all incuded subjects were eligible to follow-up, except those living outside Reunion Island or having a serious disability conducting to real difficulties to collect data. |
| Database objective | |
| Main objective |
Primary objective: to evaluate the long-term effectiveness of an intervention promoting a healthy diet and the practice of a moderate regular physical activity, on body weight and adiposity (waist circumference, fat mass), in Type-2 diabetes mellitus (T2DM) high-risk young adults.
Secondary objectives: - To compare body weight change and adiposity change between groups (intervention versus control) in the entire cohort including all screened persons (with high-risk status or not). - To compare diet and physical activity reported at follow-up, between groups, then according to the intervention adherence. - To compare incidence of screened glycemic impairments between groups and according to the baseline risk level. - To describe change in knowledge and beliefs on both T2DM and obesity (KABP). |
| Inclusion criteria |
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% |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
La Réunion |
| Detail of the geography area | Geographical coverage: two groups of inhabitants, each one selected within a vulnerable district (defined by low SES) from the municipality of Saint-Pierre (on Reunion Island), Basse-Terre / JoliFond (intervention group) and Ravine des Cabris (control group). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 08/2001 |
| Date of last collection (YYYY or MM/YYYY) | 04/2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | At inclusion:- 1251 screened persons. - 445 high-risk persons. *- 806 collateral persons screened without "high-risk" status. * The short-term effectiveness of the lifestype intervention was evaluate on a total of 439 high-risk subjects (see: Favier et al. Rev Med Ass Maladie 2005). However, six non eligible persons had participated to the intervention: 4 collateral individuals (without high-risk status), plus two high-risk individuals aged 41 and 45 respectively. Although these participants were excluded from the short-term effectiveness analysis according to population selection criteria, we decided to include them in the follow-up process and to classified them in the intervention group to follow the intention-to-treat principle in the analysis of the long-term effectiveness of the lifestyle intervention, leading to 445 high-risk subjects included in the REDIA-prev1 Cohort Study. |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data Administrative data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | In-home screening of T2DM risk factors. Anthropometric measurements: body weight, height (for body mass index calculation), waist circumference, fat mass by impedancemetry (TANITA). Blood pressure measurements (x2). Data collection on personal history, diabetes familial history and lifestyle. |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | In-home survey. Diet: assessment conducted by trained investigators using a 7-days food consumption questionnaire with food portion size estimated by a photo album. Data on diet history since intervention completion were also collected. Physical activity: assessment conducted by trained investigators using a questionnaire derived from the Baecke model (45 items on physical activity at work, at home, during sport and leisure, for specific scores calculation). Data on physical activity history since intervention completion were also collected. Knowledge and beliefs on both T2DM and obesity: risk factors, consequences on health and prevention means. |
| Biological data (detail) | Fasting required: lipid (total cholesterol, HDL cholesterol, triglycerides), glucose balance (including HbA1c) and insulinaemic. Urine test (proteinuria, microalbuminuria). |
| Administrative data (detail) | Personal data: gender, date of birth, marital status and occupation, education, last occupation by parents and spouse. Collective data: household size (number of persons residing there). |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Others |
| Other (detail) | Body weight, nutritional status (body mass index), adiposity (waist circumference, fat mass), glycemic status and others components of metabolic syndrome, reported behaviors, knowledges and beliefs on health. |
| Procedures | |
| Data collection method | Home-visit # 1: medical examination by a research-skilled nurse (approximate duration = 30 min). Home-visit # 2: within a few days to a few weeks after the first visit, survey on history of lifestyle since trial completion, and knowledge related to health, by a dietician monitoring (60 min duration). |
| Classifications used | 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. |
| Quality procedure(s) used | 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. |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Details on monitoring of participants | Research timeframe: inclusion between August 2001 and October 2002, trial competion between March and July 2003, post-intervention follow-up between October 2010 and April 2011. |
| Followed pathology | E66 - Obesity |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | c10-06_proto_vf_autorisee_28mai10.pdf |
| Description | Protocol research of the REDIA-prev1 Cohort Study (2010-2011): document in French |
| Link to the document | Favier_Revue_Med_Assurance_Mal_2005.pdf |
| Description | Results of the intervention controlled trial (2001-2003): Publication in French |
| Link to the document | doi:10.1371/journal.pone.0146095 |
| Description | Publication of the follow-up results on nine-year changes from inclusion in adiposity : body weight, body mass index, and waist circumference |
| Link to the document | DOI: 10.3917/spub.174.0525 |
| Description | Description of the REDIA-prev1 intervention and analysis of its transferability using the 'key functions/implementation/context' approach (FIC). |
| Access | |
| Dedicated website | Epidemiologie - France Portal |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) | To define. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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