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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).

ABSTRACT: Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.

SUBMITTER: Represas-Carrera F

PROVIDER: S-EPMC8198299 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFamily members of critically ill patients face considerable uncertainty and distress during their close others' intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.MethodsTo test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after 3, 6, and 12 months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.DiscussionThis trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and could be scaled up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.Trial registrationClinicalTrials.gov NCT05280691 . Prospectively registered on 20 February 2022.

Project description:BackgroundPrevious studies have shown that multicomponent interventions may improve meal frequency and eating habits in children, but evidence among young people is limited. This study evaluated the effect of the Healthy High School (HHS) intervention on daily intake of breakfast, lunch, water, fruit, and vegetables at 9-month follow-up.MethodsThe study included first-year students (≈16 years) attending high school in Denmark. Participating schools were randomized into the HHS intervention (N = 15) or control group (operating as usual) (N = 15). The intervention was designed to promote well-being (primary outcome) by focusing on healthy habits including meals, stress prevention, and strong peer relations. It included a curriculum, structural and organisational initiatives, a workshop, and a smartphone application. Students completed self-administered online questionnaires at the beginning of the school year and nine months later. To account for clustering of data, we used multilevel logistic regression analyses to estimate odds ratios (OR). We applied an intention-to-treat approach with multiple imputations of missing data.ResultsAt baseline 4577 of 5201 students answered the questionnaire and 4512 at follow-up. In both groups the proportion of students eating breakfast decreased from approximately 50% to 40% from baseline to follow-up, and lunch frequency decreased from approximately 50% to 47%. Daily water intake, intake of fresh fruit and intake of vegetables remained unchanged from baseline to follow-up. There were no significant between group differences on any of the outcomes at first follow-up: breakfast: OR = 0.85 (95% CI: 0.65;1.10), lunch: OR = 0.96 (95% CI: 0.75;1.22), water intake: OR = 1.14 (95% CI: 0.92;1.40), intake of fresh fruit: (OR = 1.07, 95% CI: 0.84;1.37), vegetables: (OR = 1.01, 95% CI: 0.77;1.33).ConclusionNo evidence of an effect of the HHS intervention was found for any of the outcomes. Future studies are warranted to explore how health promoting interventions can be integrated in further education to support educational goals. Moreover, how to fit interventions to the lives and wishes of young people, by also including systems outside of the school setting.Trial registrationISRCTN, ISRCTN43284296 . Registered 28 April 2017 - retrospectively registered.

Project description:BackgroundThis study aimed to evaluate the effectiveness of a) a Multiple Health Behaviour Change (MHBC) intervention on reducing smoking, increasing physical activity and adherence to a Mediterranean dietary pattern in people aged 45-75 years compared to usual care; and b) an implementation strategy.MethodsA cluster randomised effectiveness-implementation hybrid trial-type 2 with two parallel groups was conducted in 25 Spanish Primary Health Care (PHC) centres (3062 participants): 12 centres (1481 participants) were randomised to the intervention and 13 (1581 participants) to the control group (usual care). The intervention was based on the Transtheoretical Model and focused on all target behaviours using individual, group and community approaches. PHC professionals made it during routine care. The implementation strategy was based on the Consolidated Framework for Implementation Research (CFIR). Data were analysed using generalised linear mixed models, accounting for clustering. A mixed-methods data analysis was used to evaluate implementation outcomes (adoption, acceptability, appropriateness, feasibility and fidelity) and determinants of implementation success.Results14.5% of participants in the intervention group and 8.9% in the usual care group showed a positive change in two or all the target behaviours. Intervention was more effective in promoting dietary behaviour change (31.9% vs 21.4%). The overall adoption rate by professionals was 48.7%. Early and final appropriateness were perceived by professionals as moderate. Early acceptability was high, whereas final acceptability was only moderate. Initial and final acceptability as perceived by the participants was high, and appropriateness moderate. Consent and recruitment rates were 82.0% and 65.5%, respectively, intervention uptake was 89.5% and completion rate 74.7%. The global value of the percentage of approaches with fidelity ≥50% was 16.7%. Eight CFIR constructs distinguished between high and low implementation, five corresponding to the Inner Setting domain.ConclusionsCompared to usual care, the EIRA intervention was more effective in promoting MHBC and dietary behaviour change. Implementation outcomes were satisfactory except for the fidelity to the planned intervention, which was low. The organisational and structural contexts of the centres proved to be significant determinants of implementation effectiveness.Trial registrationClinicalTrials.gov , NCT03136211 . Registered 2 May 2017, "retrospectively registered".

Project description:Tobacco smoking might be impacted by various influences, including psychological, socio-cultural, and economic factors. A community-based cross-sectional survey was conducted in Syrian Arab Republic from March to April 2019 using a web-based questionnaire. The survey aimed at assessing tobacco use (shisha and cigarettes) as well as examining the association between current tobacco use and various sociodemographic and war-related factors. The sample comprised 978 participants (251 males: 727 females) and had a mean age of 24.7 years (SD: 7.60). Most participants were single (n = 825, 84.4%), reside in Damascus and Rif-Dimashq (n = 579, 59.2%), and had a college/university education (n = 911, 93.1%). Concerning smoking, a total of 371 participants (37.9%) were identified to be current tobacco smokers, of whom 211, 84, 76 were exclusive shisha smokers, exclusive cigarette smokers, and dual smokers, respectively. The prevalence of cigarette smoking (exclusive and dual) among males and females was found to be 34.7%, and 10.0%, respectively. On the other hand, the prevalence of shisha smoking (exclusive and dual) among males and females was around 34.3% and 27.6%, respectively. Additionally, various factors have predicted a higher likelihood of cigarette smoking including male gender (AOR = 4.152; 95% CI: 2.842-6.064; p<0.001), and losing someone due to the war (AOR = 1.487; 95% CI: 1.028-2.151; p = 0.035), while unemployed individuals were found to have lower odds of being cigarette smokers (AOR = 0.634; 95% CI: 0.429-0.937; p = 0.022). Concerning shisha smoking, married (AOR = 0.622; 95% CI: 0.402-0.963; p = 0.033), and unemployed individuals (AOR = 0.679; 95% CI: 0.503-0.916; p = 0.011) were found to have lower odds of shisha smoking. Amid the tobacco epidemic in the region, rates of tobacco use in Syria are still worrying. The Syrian armed conflicts may possess a double-edged effect on smoking, and tobacco users who adopt smoking to cope with various stressors should be targeted with well-structured health education, along with appropriate psychological services.

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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).

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