Attrition and social vulnerability during 2-year-long structured care in type 2 diabetes, the ERMIES randomized controlled trial.

BACKGROUND: Diabetes self-management education is exposed to attrition from services and structured ambulatory care. However, knowledge about factors related to attrition in educational programs remains limited. The context of social vulnerability due to low income may interfere. The aim of this study was to identify the sociodemographic, clinical, psychometric, and lifestyle factors associated with attrition from the ERMIES multicentre randomized parallel controlled trial (RCT) that was interrupted due to the combination of both slow inclusion and high attrition. METHODS: The ERMIES trial was performed from 2011 to 2016 on Reunion Island, which is characterized by a multicultural population and high social vulnerability. The original objective of the RCT was to test the efficacy of a2-year structured group self-management education in improving blood glucose in adult patients with nonrecent, insufficiently controlled type 2 diabetes. One hundred participants were randomized to intensive educational intervention maintained over two years (n = 51) versus only initial education (n = 49). Randomization was stratified on two factors: centres (five strata) and antidiabetic treatment (two strata: insulin-treated or not). Sociodemographic, clinical, health-care access and pathway, psychometric and lifestyle characteristics data were collected at baseline and used to assess determinants of attrition in a particular social context and vulnerability. Attrition and retention rates were measured at each visit during the study. Multiple correspondence analysis and Cox regression were performed to identify variables associated with attrition. RESULTS: The global attrition rate was 26% during the study, with no significant difference between the two arms of randomization (9 dropouts out of 51 patients in the intervention group and 17 out of 49 in the control group). Male gender, multiperson household, low household incomes (< 800 euros), probable depression and history of hospitalization or medical leave at inclusion were associated with a higher risk of attrition from the study in multivariate regression. CONCLUSIONS: Social context, vulnerability, and health care history were related to attrition in this 2-year longitudinal comparative study of structured care. Considering these potential determinants and biases is of importance in scaling up interventions aimed at the optimization of long-term care in type 2 diabetes mellitus. TRIAL REGISTRATION: ID_RCB number: 2011-A00046-35, Clinicaltrials.gov number: NCT01425866 (Registration date: 30/08/2011). SOURCE OF FUNDING: Ministry of Health, France.

Mortality and severe morbidity of very preterm infants: comparison of two French cohort studies.

BACKGROUND: In Reunion Island, a French overseas department, the burden of preterm birth and perinatal mortality exceed those observed in mainland France, despite similar access to standard perinatal care. The purpose of the study was to compare the outcome of two cohorts of NICU-admitted very preterm infants born between 24 and 31 weeks of gestation (WG): the registry-based OGP (Observatoire de la Grande Prématurité, Reunion Island, 2008-2013) cohort, and the nationwide EPIPAGE-2 (mainland France, 2011) observational cohort. METHODS: The primary outcome was adverse neonatal outcomes defined as a composite indicator of in-hospital mortality or any of three following severe morbidities: bronchopulmonary dysplasia (BPD), necrotising enterocolitis, or severe neurological injury (periventricular leukomalacia or grade III-IV intraventricular haemorrhages). Logistic regression modelling adjusting for confounders was performed. RESULTS: A total of 1272 very preterm infants from the Reunionese OGP cohort and 3669 peers from the mainland EPIPAGE-2 cohort were compared. Adverse neonatal outcomes were more likely observed in the OGP cohort (32.6% versus 26.6%, p <  0.001), as result of both increased in-hospital mortality across all gestational age strata and increased BPD among the survivors of the 29-31 WG stratum. After adjusting for gestational age, gender and multiple perinatal factors, the risk of adverse neonatal outcomes was higher in the OGP cohort than in the EPIPAGE-2 cohort across all gestational age strata. CONCLUSIONS: Despite similar guidelines for standard perinatal care, very preterm infants born in Reunion Island have a higher risk for death or severe morbidity compared with those born in mainland France.

Prevalence, treatment and control of hypertension in La Réunion: the RÉDIA population-based cohort study.

A better knowledge of prevalence, management and determinants of hypertension is needed in regions in epidemiological transition to adapt the strategies of public health screening and prevention, and to reduce the burden of cardiovascular diseases. We conducted a prospective cohort study including 4610 participants aged between 18 and 69 years and representative of the general population of La Réunion, a French overseas island located in the western Indian Ocean. The median time between inclusion and follow-up was 7.4 years. Blood pressure data at baseline and follow-up of 3087 participants were analyzed. We found a high prevalence of hypertension, especially in women (36.7% [34.5-39.0]) and in men (40.3% [37.6-43.0]) and in the under 30s (17.1% [14.0-20.5]), with an increase of 10% at follow-up. Treatment rates were very low in men (19.5% versus 39.1% in women) as was awareness of their condition (25.7% versus 44.6%). Blood pressure control rates were similar (18% at baseline and 34% at follow-up for both sexes). Diagnosis of hypertension at follow-up among subjects normotensive at baseline was independently associated with obesity at baseline (relative risk (RR) = 1.40 [1.12-1.75] for BMI between 27 and 30 kg/m2 and 1.72 [1.33-2.25] for BMI ≥30 kg/m2 as compared with BMI <27 kg/m2) and HbA1C (RR =1.12 [1.05-1.19] per %), suggesting a prominent role of insulin resistance in our population. Our study provides original data that cannot be assimilated to any existing model and should guide the implementation of original community-based programs in such countries.

Health Impacts of the COVID-19 Lockdown Measure in a Low Socio-Economic Setting: A Cross-Sectional Study on Reunion Island.

In March 2020, the French government implemented nation-wide measures to reduce social contact and slow the progression of the emerging coronavirus responsible for COVID-19, the most significant being a complete home lockdown that lasted 8 weeks. Reunion Island is a French overseas department marked by large social inequalities. We draw the hypothesis that distancing and lockdown measures may have contributed to an increase in the social inequalities in health (SIH) on Reunion Island. The aim of our study was to describe the SIH during lockdown in the Reunionese population. We implemented a cross-sectional telephone survey conducted between 13 May and 22 July 2020, using a retrospective data collection on the lockdown period. A total of 892 adult participants (≥18 years) were recruited in the 114 large Reunionese neighborhoods using the quota method within the national "White Pages" telephone directory. Degraded psychological states, an increase in addictive behaviors, difficulties in accessing food, a decrease in physical activity, delayed medical appointments, violence against women, and health problems in children were driven by the socio-economic characteristics of the population, most often to the disadvantage of social groups exposed to poor living conditions. These results suggest that the COVID-19 lockdown contributed to an increase in SIH.

Adapted physical activity and cardiac coherence in hematologic patients (APACCHE): study protocol for a randomized controlled trial.

BACKGROUND: Hematologic malignancies and their treatments are recognized for their significant long-term adverse effects on health-related quality of life. As a part of cancer treatment, physical exercise is known to improve physical functioning, but there are still questions regarding its impact on psychological and emotional functioning. Nonetheless, heart rate variability biofeedback (HRVB) is recognized for its positive effects on autonomic nervous system balance and emotional self-regulation. The Adapted Physical Activity and Cardiac Coherence in Hematologic Patients (APACCHE) protocol is a randomized, controlled superiority trial designed to evaluate the effects of HRBV training combined with an adaptive physical activity (APA) program compared to APA alone on the post-treatment quality of life of adult hematologic patients. METHODS: Seventy patients aged 18-70 years, with various forms of hematological malignancies, in post-treatment remission within six months prior to beginning the study and who have been prescribed APA by a hematologist, will be randomly allocated in a 1:1 ratio to two 12-week treatment groups: HRVB + APA versus APA alone. APA sessions will consist of aerobic and resistance training for 1-h twice weekly. The HRVB training will consist of controlled breathing exercises with biofeedback of heart rate variability for 10 sessions and will include a daily home-based practice. The primary outcome will be to evaluate health-related quality of life (QLQ-C30, SF-36). The secondary outcomes will be to evaluate fatigue (MFI-20); anxiety and depression (HADS); clinical status with blood pressure, progression-free survival, overall survival, and body mass index; heart rate variability level and cardiac coherence score. All of these assessments will be evaluated initially (T1), 6 weeks after (T2), at the end of the 12 weeks (T3), and then at a 12-week post-intervention follow-up (T4). DISCUSSION: To our knowledge, this is the first protocol to investigate the additional value of HRVB on physical exercise. In addition, there has been no study previously published about HRVB in hematologic patients. We hypothesize that overall quality of life and psychological and physical functioning will be improved, potentially offering a better understanding of supportive cancer care in hematology and inferring new perspectives in psychophysiological research in cancer. TRIAL REGISTRATION: Current randomized controlled trial was registered 29 November 2017 on Clinical Trials.gov (NCT number: NCT03356171).

Characterisation of health literacy strengths and weaknesses among people at metabolic and cardiovascular risk: Validity testing of the Health Literacy Questionnaire.

OBJECTIVES: Health literacy refers to the ability of individuals to gain access to, use, and understand health information and services in order to maintain a good health. The assessment of health literacy profiles in a population is potentially crucial to respond to health needs. The Health Literacy Questionnaire explores nine dimensions of health literacy and has been shown to display robust psychometric properties. The aim was to test the validity of the multidimensional Health Literacy Questionnaire and to describe the health literacy profiles in a French population at risk of cardiovascular disease. METHODS: Data were collected using self-administered questionnaires from 175 participants attending health education and support programmes in local associations of patients in Paris. Analysis included scale reliability, confirmatory factor analysis, and health literacy profiles via descriptive statistics. RESULTS: In confirmatory factor analysis, the nine-factor structure was close to the original Health Literacy Questionnaire. A nine-factor confirmatory factor analysis model was fitted to the 44 items with no cross-loadings or correlated residuals allowed. Given the restricted nature of the model, the fit was satisfactory: χ2 WLSMV(866 df) = 1383.81, p = 0.0000, comparative fit index = 0.925, Tucker-Lewis index = 0.918, root mean square error of approximation = 0.058, weighted root mean square residual = 1.175. Composite reliability ranged from 0.77 to 0.91. Among the 9 scales of the Health Literacy Questionnaire, the highest scores were found for scale 1 'Feeling understood and supported by healthcare professionals' and scale 9 'Understand health information enough to know what to do' and the lowest for scale 2 'Having sufficient information to manage my health' and scale 7 'Navigating the healthcare system'. CONCLUSION: The French version of the Health Literacy Questionnaire was shown to be psychometrically robust with good reliability. In the context of France, the 9 scales of Health Literacy Questionnaire allow a thorough assessment of health literacy strengths and weaknesses to respond to health literacy needs and improve the accessibility of health information and services.

Individualized Exercise Training at Maximal Fat Oxidation Combined with Fruit and Vegetable-Rich Diet in Overweight or Obese Women: The LIPOXmax-Réunion Randomized Controlled Trial.

OBJECTIVES: Lifestyle combined interventions are a key strategy for preventing type-2 diabetes (T2DM) in overweight or obese subjects. In this framework, LIPOXmax individualized training, based on maximal fat oxidation [MFO], may be a promising intervention to promote fat mass (FM) reduction and prevent T2DM. Our primary objective was to compare three training programs of physical activity combined with a fruit- and vegetable-rich diet in reducing FM in overweight or obese women. DESIGN AND SETTING: A five months non-blinded randomized controlled trial (RCT) with three parallel groups in La Réunion Island, a region where metabolic diseases are highly prevalent. SUBJECTS: One hundred and thirty-six non-diabetic obese (body mass index [BMI]: 27-40 kg/m2) young women (aged 20-40) were randomized (G1: MFO intensity; G2: 60% of VO2-peak intensity; G3: free moderate-intensity at-home exercise following good physical practices). OUTCOMES: Anthropometry (BMI, bodyweight, FM, fat-free mass), glucose (fasting plasma glucose, insulin, HOMA-IR) and lipid (cholesterol and triglycerides) profiles, and MFO values were measured at month-0, month-3 and month-5. RESULTS: At month-5, among 109 women assessed on body composition, the three groups exhibited a significant FM reduction over time (G1: -4.1±0.54 kg; G2: -4.7±0.53 kg; G3: -3.5±0.78 kg, p<0.001, respectively) without inter-group differences (p = 0.135). All groups exhibited significant reductions in insulin levels or HOMA-IR index, and higher MFO values over time (p<0.001, respectively) but glucose control improvement was higher in G1 than in G3 while MFO values were higher in G1 than in G2 and G3. Changes in other outcome measures and inter-group differences were not significant. CONCLUSION: In our RCT the LIPOXmax intervention did not show a superiority in reducing FM in overweight or obese women but is associated with higher MFO and better glucose control improvements. Other studies are required before proposing LIPOXmax training for the prevention of T2DM in overweight or obese women. TRIAL REGISTRATION: ClincialTrials.gov NCT01464073.