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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).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
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.
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Behaviour change, weight loss and remission of Type 2 diabetes: a community-based prospective cohort study.
Dambha-Miller, H, Day, AJ, Strelitz, J, Irving, G, Griffin, SJ
Diabetic medicine : a journal of the British Diabetic Association. 2020;37(4):681-688
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Type 2 Diabetes is considered a lifelong condition, but calorie restriction or weight loss can lead to complete remission. Patients newly diagnosed with Type 2 Diabetic may benefit from behavioural change over the long run. When Type 2 Diabetes is diagnosed early in the disease trajectory, it may increase the patient's motivation and make them more receptive to weight-loss interventions. This prospective cohort study included 865 newly diagnosed Type 2 diabetic patients from the ADDICTION Cambridge Trial, a pragmatic, parallel-group cluster randomised controlled trial. The study assessed the relationship between behaviour change and weight loss and the prospect of type 2 diabetes remission in the first year, following four years and after five years without intense dietary or lifestyle intervention in patients. 30% of the patients achieved diabetes remission at 5-year follow-up, with a significant likelihood of remission among those who achieved ≥ 10% weight loss in the first year of diagnosis. A self-reported change in intake of alcohol units was found to be the only consistent association between behaviour change and remission in this study. The role of behaviour change in the remission of diabetes requires further robust research. This study will help healthcare professionals understand the association between weight loss and remission in diabetic patients.
Abstract
AIM: To quantify the association between behaviour change and weight loss after diagnosis of Type 2 diabetes, and the likelihood of remission of diabetes at 5-year follow-up. METHOD We conducted a prospective cohort study in 867 people with newly diagnosed diabetes aged 40-69 years from the ADDITION-Cambridge trial. Participants were identified via stepwise screening between 2002 and 2006, and underwent assessment of weight change, physical activity (EPAQ2 questionnaire), diet (plasma vitamin C and self-report), and alcohol consumption (self-report) at baseline and 1 year after diagnosis. Remission was examined at 5 years after diabetes diagnosis via HbA1c level. We constructed log binomial regression models to quantify the association between change in behaviour and weight over both the first year after diagnosis and the subsequent 1-5 years, as well as remission at 5-year follow-up. RESULTS Diabetes remission was achieved in 257 participants (30%) at 5-year follow-up. Compared with people who maintained the same weight, those who achieved ≥ 10% weight loss in the first year after diagnosis had a significantly higher likelihood of remission [risk ratio 1.77 (95% CI 1.32 to 2.38; p<0.01)]. In the subsequent 1-5 years, achieving ≥10% weight loss was also associated with remission [risk ratio 2.43 (95% CI 1.78 to 3.31); p<0.01]. CONCLUSION In a population-based sample of adults with screen-detected Type 2 diabetes, weight loss of ≥10% early in the disease trajectory was associated with a doubling of the likelihood of remission at 5 years. This was achieved without intensive lifestyle interventions or extreme calorie restrictions. Greater attention should be paid to enabling people to achieve weight loss following diagnosis of Type 2 diabetes.
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Change in physical activity level and clinical outcomes in older adults with knee pain: a secondary analysis from a randomised controlled trial.
Quicke, JG, Foster, NE, Croft, PR, Ogollah, RO, Holden, MA
BMC musculoskeletal disorders. 2018;19(1):59
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Exercise improves pain and function in adults with knee pain due to osteoarthritis. To date, no studies have investigated if changes in physical activity level can explain this improvement in pain and function. This longitudinal study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain. Participants were adults over the age of 45, who were already taking part in a trial of exercise interventions on knee pain. Change in physical activity was measured using a self-reported scale from baseline to 3 months. Pain and physical function were measured at baseline, 3 months and 6 months. Change in physical activity level was not associated with pain or physical function at 3 or 6 months. The authors suggest that other factors may be responsible for clinical improvements following exercise interventions, and recommend further investigation into the responsiveness of commonly used physical activity measures.
Abstract
BACKGROUND Exercise interventions improve clinical outcomes of pain and function in adults with knee pain due to osteoarthritis and higher levels of physical activity are associated with lower severity of pain and higher levels of physical functioning in older adults with knee osteoarthritis in cross-sectional studies. However, to date no studies have investigated if change in physical activity level during exercise interventions can explain clinical outcomes of pain and function. This study aimed to investigate if change in physical activity during exercise interventions is associated with future pain and physical function in older adults with knee pain. METHODS Secondary longitudinal data analyses of a three armed exercise intervention randomised controlled trial. Participants were adults with knee pain attributed to osteoarthritis, over the age of 45 years old (n = 514) from Primary Care Services in the Midlands and Northwest regions of England. Crude and adjusted associations between absolute change in physical activity from baseline to 3 months (measured by the self-report Physical Activity Scale for the Elderly (PASE)) and i) pain ii) physical function (Western Ontario and McMaster Universities Osteoarthritis Index) and iii) treatment response (OMERACT-OARSI responder criteria) at 3 and 6 months follow-up were investigated using linear and logistic regression. RESULTS Change in physical activity level was not associated with future pain, function or treatment response outcomes in crude or adjusted models at 3 or 6 months (P > 0.05). A 10 point increase in PASE was not associated with pain β = - 0.01 (- 0.05, 0.02), physical function β = - 0.09 (- 0.19, 0.02) or likelihood (odds ratio) of treatment response 1.02 (0.99, 1.04) at 3 months adjusting for sociodemographics, clinical covariates and the trial intervention arm. Findings were similar for 6 month outcome models. CONCLUSIONS Change in physical activity did not explain future clinical outcomes of pain and function in this study. Other factors may be responsible for clinical improvements following exercise interventions. However, the PASE may not be sufficiently responsive to measure change in physical activity level. We also recommend further investigation into the responsiveness of commonly used physical activity measures. TRIAL REGISTRATION ( ISRCTN93634563 ). Registered 29th September 2011.
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Effect of physical exercise on musculoskeletal pain in multiple body regions among healthcare workers: Secondary analysis of a cluster randomized controlled trial.
Jakobsen, MD, Sundstrup, E, Brandt, M, Andersen, LL
Musculoskeletal science & practice. 2018;34:89-96
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Musculoskeletal pain in the neck, shoulder and lower back is the most common and costly work-related health problem. While physical exercise has been shown to be beneficial for back and neck/shoulder pain, only a few studies have evaluated the effects on pain in multiple body regions. The aim of this study was to evaluate the effect of workplace versus home-based physical exercise on the pressure pain threshold (PPT) and musculoskeletal pain intensity in multiple body regions. This study consisted of secondary analysis of a randomised controlled trial. 200 female healthcare workers from three hospitals were randomised to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 5 × 10 min per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 5 × 10 min per week and up to 5 motivational coaching sessions. PPT (neck, lower back, lower leg) and perceived pain intensity in multiple body regions (feet, knee, hips, lower and upper back, elbow, hand, shoulder, neck, and head) were measured at baseline and 10-week follow-up. In some of the body regions, PPT and pain intensity improved more following WORK than HOME exercises. Significant better improvements were found for PPT in the lower back, and pain intensity in the lower back and feet. HOME did not improve more than WORK for any of the measurements. The authors concluded that physical exercise recommendations for healthcare workers should consider the setting, i.e. performing supervised group-based exercise at work and motivational coaching sessions is more effective than exercising alone at home.
Abstract
BACKGROUND While physical exercise is beneficial for back and neck-shoulder pain, only few intervention studies have evaluated effects on pain in multiple body regions. Furthermore, direct measurement of pain threshold can provide additional information to self-reported pain intensity. OBJECTIVES To evaluate the effect of workplace versus home-based physical exercise on pressure pain threshold (PPT) and musculoskeletal pain intensity in multiple body regions. STUDY DESIGN Secondary analysis of an examiner-blinded, cluster randomized controlled trial with allocation concealment. METHOD Two-hundred female healthcare workers from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 5 × 10 min per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 5 × 10 min per week and up to 5 motivational coaching sessions. PPT (neck, lower back, lower leg) and perceived pain intensity in multiple body regions (feet, knee, hips, lower and upper back, elbow, hand, shoulder, neck, and head) were measured at baseline and 10-week follow-up. RESULTS In some of the body regions, PPT and pain intensity improved more following WORK than HOME. Between-group differences at follow-up (WORK vs. HOME) were 41 kPA [95% CI 13-70, effect size (ES): 0.22] for PPT in the lower back, and -0.7 [95% CI -1.0-0.3, ES: 0.26] and -0.6 points [95% CI -0.9--0.2, ES: 0.23] for pain intensity in the lower back and feet, respectively. HOME did not improve more than WORK for any of the measurements. CONCLUSION Physical exercise recommendations for healthcare workers should consider the setting, i.e. performing supervised group-based exercise at work and motivational coaching sessions is more effective than exercising alone at home.