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Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials.
Moschonis, G, Siopis, G, Jung, J, Eweka, E, Willems, R, Kwasnicka, D, Asare, BY, Kodithuwakku, V, Verhaeghe, N, Vedanthan, R, et al
The Lancet. Digital health. 2023;(3):e125-e143
Abstract
BACKGROUND Digital health interventions have shown promising results for the management of type 2 diabetes, but a comparison of the effectiveness and implementation of the different modes is not currently available. Therefore, this study aimed to compare the effectiveness of SMS, smartphone application, and website-based interventions on improving glycaemia in adults with type 2 diabetes and report on their reach, uptake, and feasibility. METHODS In this systematic review and meta-analysis, we searched CINAHL, Cochrane Central, Embase, MEDLINE, and PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) that examined the effectiveness of digital health interventions in reducing glycated haemoglobin A1c (HbA1c) in adults with type 2 diabetes, published in English from Jan 1, 2009. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint assessed was the change in the mean (and 95% CI) plasma concentration of HbA1c at 3 months or more. Cochrane risk of bias 2 was used to assess risk of bias. Data on reach, uptake, and feasibility were summarised narratively and data on HbA1c reduction were synthesised in a meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation criteria was used to evaluate the level of evidence. The study was registered with PROSPERO, CRD42021247845. FINDINGS Of the 3236 records identified, 56 RCTs from 24 regions (n=11 486 participants), were included in the narrative synthesis, and 26 studies (n=4546 participants) in the meta-analysis. 20 studies used SMS as the primary mode of delivery of the digital health intervention, 25 used smartphone applications, and 11 implemented interventions via websites. Smartphone application interventions reported higher reach compared with SMS and website-based interventions, but website-based interventions reported higher uptake compared with SMS and smartphone application interventions. Effective interventions, in general, included people with greater severity of their condition at baseline (ie, higher HbA1c) and administration of a higher dose intensity of the intervention, such as more frequent use of smartphone applications. Overall, digital health intervention group participants had a -0·30 (95% CI -0·42 to -0·19) percentage point greater reduction in HbA1c, compared with control group participants. The difference in HbA1c reduction between groups was statistically significant when interventions were delivered through smartphone applications (-0·42% [-0·63 to -0·20]) and via SMS (-0·37% [-0·57 to -0·17]), but not when delivered via websites (-0·09% [-0·64 to 0·46]). Due to the considerable heterogeneity between included studies, the level of evidence was moderate overall. INTERPRETATION Smartphone application and SMS interventions, but not website-based interventions, were associated with better glycaemic control. However, the studies' heterogeneity should be recognised. Considering that both smartphone application and SMS interventions are effective for diabetes management, clinicians should consider factors such as reach, uptake, patient preference, and context of the intervention when deciding on the mode of delivery of the intervention. Nine in ten people worldwide own a feature phone and can receive SMS and four in five people have access to a smartphone, with numerous smartphone applications being available for diabetes management. Clinicians should familiarise themselves with this modality of programme delivery and encourage people with type 2 diabetes to use evidence-based applications for improving their self-management of diabetes. Future research needs to describe in detail the mediators and moderators of the effectiveness and implementation of SMS and smartphone application interventions, such as the optimal dose, frequency, timing, user interface, and communication mode to both further improve their effectiveness and to increase their reach, uptake, and feasibility. FUNDING EU's Horizon 2020 Research and Innovation Programme.
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Cost effectiveness review of text messaging, smartphone application, and website interventions targeting T2DM or hypertension.
Willems, R, Annemans, L, Siopis, G, Moschonis, G, Vedanthan, R, Jung, J, Kwasnicka, D, Oldenburg, B, d'Antonio, C, Girolami, S, et al
NPJ digital medicine. 2023;(1):150
Abstract
Digital health interventions have been shown to be clinically-effective for type 2 diabetes mellitus (T2DM) and hypertension prevention and treatment. This study synthesizes and compares the cost-effectiveness of text-messaging, smartphone application, and websites by searching CINAHL, Cochrane Central, Embase, Medline and PsycInfo for full economic or cost-minimisation studies of digital health interventions in adults with or at risk of T2DM and/or hypertension. Costs and health effects are synthesised narratively. Study quality appraisal using the Consensus on Health Economic Criteria (CHEC) list results in recommendations for future health economic evaluations of digital health interventions. Of 3056 records identified, 14 studies are included (7 studies applied text-messaging, 4 employed smartphone applications, and 5 used websites). Ten studies are cost-utility analyses: incremental cost-utility ratios (ICUR) vary from dominant to €75,233/quality-adjusted life year (QALY), with a median of €3840/QALY (interquartile range €16,179). One study finds no QALY difference. None of the three digital health intervention modes is associated with substantially better cost-effectiveness. Interventions are consistently cost-effective in populations with (pre)T2DM but not in populations with hypertension. Mean quality score is 63.0% (standard deviation 13.7%). Substandard application of time horizon, sensitivity analysis, and subgroup analysis next to transparency concerns (regarding competing alternatives, perspective, and costing) downgrades quality of evidence. In conclusion, smartphone application, text-messaging, and website-based interventions are cost-effective without substantial differences between the different delivery modes. Future health economic studies should increase transparency, conduct sufficient sensitivity analyses, and appraise the ICUR more critically in light of a reasoned willingness-to-pay threshold.Registration: PROSPERO (CRD42021247845).
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Extra virgin olive oil improves HDL lipid fraction but not HDL-mediated cholesterol efflux capacity: a double-blind, randomised, controlled, cross-over study (OLIVAUS).
Sarapis, K, George, ES, Marx, W, Mayr, HL, Willcox, J, Powell, KL, Folasire, OS, Lohning, AE, Prendergast, LA, Itsiopoulos, C, et al
The British journal of nutrition. 2023;(4):641-650
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Abstract
Olive oil (OO) polyphenols have been shown to improve HDL anti-atherogenic function, thus demonstrating beneficial effects against cardiovascular risk factors. The aim of the present study was to investigate the effect of extra virgin high polyphenol olive oil (HPOO) v. low polyphenol olive oil (LPOO) on the capacity of HDL to promote cholesterol efflux in healthy adults. In a double-blind, randomised cross-over trial, fifty participants (aged 38·5 (sd 13·9) years, 66 % females) were supplemented with a daily dose (60 ml) of HPOO (320 mg/kg polyphenols) or LPOO (86 mg/kg polyphenols) for 3 weeks. Following a 2-week washout period, participants crossed over to the alternate treatment. Serum HDL-cholesterol efflux capacity, circulating lipids (i.e. total cholesterol, TAG, HDL, LDL) and anthropometrics were measured at baseline and follow-up. No significant between-group differences were observed. Furthermore, no significant changes in HDL-cholesterol efflux were found within either the LPOO and HPOO treatment arms; mean changes were 0·54 % (95 % CI (0·29, 1·37)) and 0·10 % (95 % CI (0·74, 0·94)), respectively. Serum HDL increased significantly after LPOO and HPOO intake by 0·13 mmol/l (95 % CI (0·04, 0·22)) and 0·10 mmol/l (95 % CI (0·02, 0·19)), respectively. A small but significant increase in LDL of 0·14 mmol/l (95 % CI (0·001, 0·28)) was observed following the HPOO intervention. Our results suggest that additional research is warranted to further understand the effect of OO with different phenolic content on mechanisms of cholesterol efflux via different pathways in multi-ethnic populations with diverse diets.
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Long-term cardiometabolic health in people born after assisted reproductive technology: a multi-cohort analysis.
Elhakeem, A, Taylor, AE, Inskip, HM, Huang, JY, Mansell, T, Rodrigues, C, Asta, F, Blaauwendraad, SM, Håberg, SE, Halliday, J, et al
European heart journal. 2023;(16):1464-1473
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AIMS: To examine associations of assisted reproductive technology (ART) conception (vs. natural conception: NC) with offspring cardiometabolic health outcomes and whether these differ with age. METHODS AND RESULTS Differences in systolic (SBP) and diastolic blood pressure (DBP), heart rate (HR), lipids, and hyperglycaemic/insulin resistance markers were examined using multiple linear regression models in 14 population-based birth cohorts in Europe, Australia, and Singapore, and results were combined using meta-analysis. Change in cardiometabolic outcomes from 2 to 26 years was examined using trajectory modelling of four cohorts with repeated measures. 35 938 (654 ART) offspring were included in the meta-analysis. Mean age ranged from 13 months to 27.4 years but was <10 years in 11/14 cohorts. Meta-analysis found no statistical difference (ART minus NC) in SBP (-0.53 mmHg; 95% CI:-1.59 to 0.53), DBP (-0.24 mmHg; -0.83 to 0.35), or HR (0.02 beat/min; -0.91 to 0.94). Total cholesterol (2.59%; 0.10-5.07), HDL cholesterol (4.16%; 2.52-5.81), LDL cholesterol (4.95%; 0.47-9.43) were statistically significantly higher in ART-conceived vs. NC offspring. No statistical difference was seen for triglycerides (TG), glucose, insulin, and glycated haemoglobin. Long-term follow-up of 17 244 (244 ART) births identified statistically significant associations between ART and lower predicted SBP/DBP in childhood, and subtle trajectories to higher SBP and TG in young adulthood; however, most differences were not statistically significant. CONCLUSION These findings of small and statistically non-significant differences in offspring cardiometabolic outcomes should reassure people receiving ART. Longer-term follow-up is warranted to investigate changes over adulthood in the risks of hypertension, dyslipidaemia, and preclinical and clinical cardiovascular disease.
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Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials.
Siopis, G, Moschonis, G, Eweka, E, Jung, J, Kwasnicka, D, Asare, BY, Kodithuwakku, V, Willems, R, Verhaeghe, N, Annemans, L, et al
The Lancet. Digital health. 2023;(3):e144-e159
Abstract
BACKGROUND Digital health interventions are effective for hypertension self-management, but a comparison of the effectiveness and implementation of the different modes of interventions is not currently available. This study aimed to compare the effectiveness of SMS, smartphone application, and website interventions on improving blood pressure in adults with hypertension, and to report on their reach, uptake, and feasibility. METHODS In this systematic review and meta-analysis we searched CINAHL Complete, Cochrane Central Register of Controlled Trials, Ovid Embase, Ovid MEDLINE, and APA PsycInfo on May 25, 2022, for randomised controlled trials (RCTs) published in English from Jan 1, 2009, that examined the effectiveness of digital health interventions on reducing blood pressure in adults with hypertension. Screening was carried out using Covidence, and data were extracted following Cochrane's guidelines. The primary endpoint was change in the mean of systolic blood pressure. Risk of bias was assessed with Cochrane Risk of Bias 2. Data on systolic and diastolic blood pressure reduction were synthesised in a meta-analysis, and data on reach, uptake and feasibility were summarised narratively. Grading of Recommendations, Assessment, Development, and Evaluation criteria were used to evaluate the level of evidence. The study was registered with PROSPERO CRD42021247845. FINDINGS Of the 3235 records identified, 29 RCTs from 13 regions (n=7592 participants) were included in the systematic review, and 28 of these RCTs (n=7092 participants) were included in the meta-analysis. 11 studies used SMS as the primary mode of delivery of the digital health intervention, 13 used smartphone applications, and five used websites. Overall, digital health intervention group participants had a -3·62 mm Hg (95% CI -5·22 to -2·02) greater reduction in systolic blood pressure, and a -2·45 mm Hg (-3·83 to -1·07) greater reduction in diastolic blood pressure, compared with control group participants. No statistically significant differences between the three different modes of delivery were observed for both the systolic (p=0·73) and the diastolic blood pressure (p=0·80) outcomes. Smartphone application interventions had a statistically significant reduction in diastolic blood pressure (-2·45 mm Hg [-4·15 to -0·74]); however, there were no statistically significant reductions for SMS interventions (-1·80 mm Hg [-4·60 to 1·00]) or website interventions (-3·43 mm Hg [-7·24 to 0·38]). Due to the considerable heterogeneity between included studies and the high risk of bias in some, the level of evidence was assigned a low overall score. Interventions were more effective among people with greater severity of hypertension at baseline. SMS interventions reported higher reach and smartphone application studies reported higher uptake, but differences were not statistically significant. INTERPRETATION SMS, smartphone application, and website interventions were associated with statistically and clinically significant systolic and diastolic blood pressure reductions, compared with usual care, regardless of the mode of delivery of the intervention. This conclusion is tempered by the considerable heterogeneity of included studies and the high risk of bias in most. Future studies need to describe in detail the mediators and moderators of the effectiveness and implementation of these interventions, to both further improve their effectiveness as well as increase their reach, uptake, and feasibility. FUNDING European Union's Horizon 2020 Research and Innovation Programme.
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Effectiveness of Technology-Enabled, Low Carbohydrate Dietary Interventions, in the Prevention or Treatment of Type 2 Diabetes Mellitus in Adults: A Systematic Literature Review of Randomised Controlled and Non-Randomised Trials.
Jooste, BR, Kolivas, D, Brukner, P, Moschonis, G
Nutrients. 2023;(20)
Abstract
Evidence suggests that low carbohydrate dietary (LCD) approaches can improve glycaemic control and may result in type 2 diabetes mellitus (T2DM) remission. This systematic literature review (SLR) aimed to assess the effectiveness of technology-enabled LCD interventions in the management of people with prediabetes or T2DM. Data sources included Medline, Embase, CINAHL, and Web of Science. Randomised (RCTs) or non-randomised (non-RCTs) controlled trials investigating the effect of technology-enabled LCDs (<130 g/day) or very low carbohydrate diets (VLCDs < 50 g/day) on glycosylated haemoglobin A1c (HbA1c) for at least three months and published in English between 2009 and 2023 were included. Risk of bias assessment, data extraction, and synthesis were conducted using standard tools and procedures. Six studies (two RCTs and four non-RCTs, total sample, n = 1519) were identified and included in the SLR. Two studies examining LCDs reported significant reductions in mean HbA1c (0.4% and -1.2%) and weight loss (-3.8 kg and -7.5 kg) at one year. Three studies examining VLCDs reported significant reductions in mean HbA1c (-0.8% to -1.3%) and weight loss (-12 kg to -14 kg) up to two years. Technology-enabled LCD or VLCD interventions can be a novel approach in helping people with prediabetes or T2DM self-manage their condition and possibly achieve remission. However, further research is required to determine the sustainability, effectiveness, and safety of this approach.
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Prospective BMI changes in preschool children are associated with parental characteristics and body weight perceptions: the ToyBox-study.
Manios, Y, Lambert, KA, Karaglani, E, Mavrogianni, C, Moreno Aznar, LA, Iotova, V, Świąder-Leśniak, A, Koletzko, B, Cardon, G, Androutsos, O, et al
Public health nutrition. 2022;(6):1552-1562
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OBJECTIVE To examine the effect of the intervention implemented in the ToyBox-study on changes observed in age- and sex-specific BMI percentile and investigate the role of perinatal factors, parental perceptions and characteristics on this change. DESIGN A multicomponent, kindergarten-based, family-involved intervention with a cluster-randomised design. A standardised protocol was used to measure children's body weight and height. Information was also collected from parents/caregivers via the use of validated questionnaires. Linear mixed effect models with random intercept for country, socio-economic status and school were used. SETTING Selected preschools within the provinces of Oost-Flanders and West-Flanders (Belgium), Varna (Bulgaria), Bavaria (Germany), Attica (Greece), Mazowieckie (Poland) and Zaragoza (Spain). PARTICIPANTS A sample of 6268 preschoolers aged 3·5-5·5 years (51·9 % boys). RESULTS There was no intervention effect on the change in children's BMI percentile. However, parents' underestimation of their children's actual weight status, parental overweight and mothers' pre-pregnancy overweight/obesity were found to be significantly and independently associated with increases in children's BMI percentile in multivariate modelling. CONCLUSIONS As part of a wide public health initiative or as part of a counseling intervention programme, it is important to assist parents/caregivers to correctly perceive their own and their children's weight status. Recognition of excessive weight by parents/caregivers can increase their readiness to change and as such facilitate higher adherence to favourable behavioural changes within the family.
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The Effect of Maternal Overweight and Obesity Pre-Pregnancy and During Childhood in the Development of Obesity in Children and Adolescents: A Systematic Literature Review.
Mannino, A, Sarapis, K, Moschonis, G
Nutrients. 2022;(23)
Abstract
Maternal overweight/obesity has been associated with an increased risk of obesity in childhood. We investigated the effect of maternal overweight/obesity during pre-pregnancy and whether it is a stronger predictor of child obesity, compared to maternal overweight/obesity during childhood. Prospective or retrospective cohort studies published in English, reporting on obese children and adolescents (2-18 years), with overweight/obese mothers in either pre-pregnancy or during childhood were included. A search was conducted from 2012 to April 2022 in MEDLINE, Web of Science, CINAHL, and EMBASE, followed by screening, data extraction, quality assessment and narrative synthesis. Eleven eligible studies (9 prospective and 2 retrospective cohort studies; total sample, n = 27,505) were identified. Eight studies examined maternal overweight/obesity in pre-conception, presenting consistent positive associations with childhood obesity, three reported positive associations between childhood obesity and maternal overweight/obesity during childhood, and one presented positive associations between both maternal exposures. The narrative synthesis failed to identify which maternal exposure is the strongest predictor of childhood obesity, with studies reporting significant associations between maternal overweight/obesity and child obesity in both time points. Intervention programs aiming to reduce childhood obesity should focus on supporting women of childbearing age with weight management from preconception and throughout their life-course.
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Assessing the effectiveness of a 4-week online intervention on food literacy and fruit and vegetable consumption in Australian adults: The online MedDiet challenge.
Ng, AH, ElGhattis, Y, Biesiekierski, JR, Moschonis, G
Health & social care in the community. 2022;(6):e4975-e4981
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Australians fail to meet the daily recommended two and five serves of fruit and vegetable respectively, which increases mortality risk for non-communicable diseases such as cardiovascular disease and type 2 diabetes. This study aimed to evaluate the effectiveness of an online intervention delivered through social media on food literacy and fruit and vegetable consumption in Australian adults. In a pre-post single group experimental study, 29 participants completed the "online MedDiet challenge", a four-week intervention delivered via Facebook. Infographics, recipes and informational videos aligned with food literacy concepts related to the Mediterranean Diet were shared with participants. Outcome measures included a validated food literacy questionnaire with two questions from the National Nutrition Survey to record fruit and vegetable consumption. The mean age of participants was 52 years (range: 25-67 years). Post intervention, food literacy improved between 21%-45% across each survey component. Participants also reported an increase in fruit and vegetable consumption by 0.6 and 1.3 serves per day (p < 0.05) respectively. Social media holds potential for increasing fruit and vegetable consumption in adults through food literacy. Future research should focus on longer studies and larger cohorts to confirm that food literacy plays a key component to maintain sustainability of such interventions.
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Extra virgin olive oil high in polyphenols improves antioxidant status in adults: a double-blind, randomized, controlled, cross-over study (OLIVAUS).
Sarapis, K, George, ES, Marx, W, Mayr, HL, Willcox, J, Esmaili, T, Powell, KL, Folasire, OS, Lohning, AE, Garg, M, et al
European journal of nutrition. 2022;(2):1073-1086
Abstract
PURPOSE Olive oil polyphenols have been associated with cardiovascular health benefits. This study examined the antioxidant and anti-inflammatory effect of extra-virgin high polyphenol olive oil (HPOO) vs. low polyphenol olive oil (LPOO) in healthy Australian adults. METHODS In a double-blind cross-over trial, 50 participants (aged 38.5 ± 13.9 years, 66% females) were randomized to consume 60 mL/day of HPOO (320 mg/kg polyphenols) or LPOO (86 mg/kg polyphenols) for three weeks. Following a 2-week wash-out period, participants crossed-over to the alternate treatment. Plasma oxidized low-density lipoprotein (ox-LDL), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP) and anthropometrics were measured at baseline and follow-up. RESULTS Fourty-three participants completed the study. Although there were no significant differences between treatments in the total sample, plasma ox-LDL decreased by 6.5 mU/mL (95%CI - 12.4 to - 0.5) and TAC increased by 0.03 mM (95% CI 0.006-0.05) only in the HPOO arm. Stratified analyses were also performed by cardiovascular disease risk status defined by abdominal obesity (WC > 94 cm in males, > 80 cm in females) or inflammation (hs-CRP > 1 mg/L). In the subgroup with abdominal obesity, ox-LDL decreased by 13.5 mU/mL (95% CI - 23.5 to - 3.6) and TAC increased by 0.04 mM (95% CI 0.006-0.07) only after HPOO consumption. In the subgroup with inflammation, hs-CRP decreased by 1.9 mg/L (95% CI - 3.7 to -0.1) only in the HPOO arm. CONCLUSIONS Although there were no significant differences between treatments, the changes observed after HPOO consumption demonstrate the antioxidant and anti-inflammatory effect of this oil, which is more pronounced in adults with high cardiometabolic risk (Clinical Trial Registration: ACTRN12618000706279).