The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial

Abstract Background People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Design Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. Entry criteria South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. Endpoints The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. Intervention Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. Results We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). Conclusion The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB approval 16/WM/0171 Trial registration EudraCT 2016-001350-18. Registered on 14 April 2016. ClinicalTrials.govNCT02949739. Registered on 31 October 2016, First posted on 31/10/2016.

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The iHealth-T2D study: rationale and design of a cluster randomised trial for prevention of Type 2 Diabetes amongst South Asians with central obesity and prediabetes

10.1101/2020.11.12.20230433 ◽

2020 ◽

Author(s):

Anuradhani Kasturiratne ◽

Khadija I Khawaja ◽

Sajjad Ahmad ◽

Samreen Siddiqui ◽

Khurram Shahzad ◽

...

Keyword(s):

Waist Circumference ◽

Usual Care ◽

Community Health ◽

Central Obesity ◽

Lifestyle Modification ◽

South Asians ◽

Research Application ◽

Link Type

AbstractBackgroundPeople from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for prevention of T2D in South Asians, that are cost-effective, generalisable and scalable across settings.HypothesisCompared to usual care, risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12 month lifestyle modification programme delivered by community health workers.DesignCluster randomised clinical trial (1:1 allocation to Intervention or Usual care), carried out in India, Pakistan, Sri Lanka, and UK, with 30 sites per country (120 sites total). Target recruitment 3,600 (30 participants per site) with annual follow-up for three years.Entry criteriaSouth Asian, men or women, age 40-70 years with i. Central obesity (waist circumference ≥100cm in India and Pakistan; ≥90cm in Sri Lanka) and / or ii. Prediabetes (HbA1c 6.0-6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index<22kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; serious illness.EndpointsThe primary end point is new onset T2D at 3 years, defined as: i. HbA1c≥6.5% or ii. Physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are: i. Physical measures: waist circumference, weight and blood pressure; ii. Lifestyle measures: smoking status, alcohol intake, physical activity, dietary intake; iii. Biochemical measures: Fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and iv. Treatment compliance.InterventionLifestyle intervention (60 sites) or Usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one session, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving e a 7% reduction in body mass index and a 10 cm reduction in waist circumference through i. improved diet and ii. increased physical activity. Usual care comprised a single 30 minute session of lifestyle modification advice from the community health worker.ResultsWe screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom, 3,682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between Intervention and Usual care sites. More than 90% of follow-up visits are scheduled to be complete December 2020. Based on follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum).ConclusionThe iHealth-T2D study will advance understanding of strategies for prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group.IRB approval16/WM/0171Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/ ; ClinicalTrials.gov NCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.FunderEuropean Commission (award 643774) and National Institute for Health Research (award 16/136/68)

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The iHealth-T2D study: Statistical analysis plan for a cluster randomised controlled trial with intensive family-based lifestyle modification programme to reduce type 2 diabetes risk amongst South Asians

10.1101/2020.11.12.20229849 ◽

2020 ◽

Author(s):

Mirthe Muilwijk ◽

Marie Loh ◽

Sara Mahmood ◽

Saranya Palaniswamy ◽

Samreen Siddiqui ◽

...

Keyword(s):

Lifestyle Modification ◽

South Asians ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Statistical Analysis Plan ◽

Link Type ◽

Family Based ◽

Randomised Controlled

AbstractBackgroundSouth Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high-costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care.MethodsThe iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 locations across India, Pakistan, Sri Lanka and the UK. A total of 3,682 South Asian men and women with age between 40-70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥95cm in Sri Lanka, or ≥100cm in India, Pakistan and UK) and/or prediabetes (HbA1c ≥6.0%)] were included in the trial. Here we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after three years of follow-up after enrolment to the study, and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after one and three years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance.DiscussionThe iHealth-T2D trial will provide evidence whether an intensive family-based lifestyle modification programme in South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP.Ethics and disseminationThe trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations.Trial registrationEudraCT 2016-001350-18. Registered 14 April 2016 https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/ihealth-t2d/; ClinicalTrials.govNCT02949739. Registered 31 October 2016, https://clinicaltrials.gov/ct2/show/NCT02949739, First posted 31/10/2016.

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Factors Associated with Poor Glycemic and Lipid Levels in Ambulatory Diabetes Mellitus Type 2 Patients in Asmara, Eritrea: A Cross-Sectional Study

Journal of Diabetes Research ◽

10.1155/2020/5901569 ◽

2020 ◽

Vol 2020 ◽

pp. 1-12 ◽

Cited By ~ 1

Author(s):

Oliver Okoth Achila ◽

Millen Ghebretinsae ◽

Abraham Kidane ◽

Michael Simon ◽

Shewit Makonen ◽

...

Keyword(s):

Diabetes Mellitus ◽

Risk Factors ◽

Waist Circumference ◽

Cross Sectional Study ◽

Sectional Study ◽

Cross Sectional ◽

Factors Associated ◽

Specific Lipid

Objective. There is a dearth of relevant research on the rapidly evolving epidemic of diabetes mellitus (particularly Type 2 diabetes mellitus) in sub-Saharan Africa. To address some of these issues in the Eritrean context, we conducted a cross-sectional study on glycemic and lipid profiles and associated risk factors. Methods. A total of 309 patients with diabetes mellitus on regular follow-up at the Diabetic and Hypertensive Department at Halibet Regional Referral Hospital, Asmara, were enrolled for the study. Data on specific clinical chemistry and anthropomorphic parameters was collected. Chi-squared (χ2) test or Fischer’s exact test was used to evaluate the relationship between specific variables. Multivariate logistic regression (backward: conditional) was undertaken to identify the factors associated with increased odds of suboptimal values in glucose and specific lipid panel subfractions. Results. High proportions of patients (76.7%) had suboptimal levels of HbA1c with a mean±SD of 8.6%±1.36, respectively. In multivariate regression analysis, the likelihood of HbA1c≥7% was higher in patients with abnormal WHR (AOR=3.01, 95% CI, 3.01 (1.15–7.92=0.024)) and in patients without hypertension (AOR=1.97, 95% CI (1.06–3.56), p=0.021). A unit reduction in eGFR was also associated with HbA1c≥7% (AOR=0.99, 95% CI (0.98–1=0.031)). In a separate analysis, the data shows that 80.9% of the patients had dyslipidemia. In particular, 62.1% of the patients had TC≥200 mg/dL (risk factors: sex, hypertension, and HbA1c concentration), 81.6% had LDL‐C≥100 mg/dL (risk factors: sex and hypertension), 56.3% had TG≥150 (risk factors: sex, HbA1c, and waist circumference), 62.8% had abnormal HDL-C (risk factors: waist circumference), 78.3% had non‐HDL<130 mg/dL (risk factors: duration of disease, reduced estimated glomerular filtration rate, and HbA1c), and 45.3% had abnormal TG/HDL (risk factors: sex, age of patient, FPG, and waist circumference). Conclusions. The quality of care, as measured by glycemic and specific lipid targets, in this setting is suboptimal. Therefore, there is an urgent need for simultaneous improvements in both indicators. This will require evidence-based optimization of pharmacological and lifestyle interventions. Therefore, additional studies, preferably longitudinal studies with long follow-up, are required on multiple aspects of DM.

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Physical Activity, Measures of Obesity, and Cardiometabolic Risk: The Multi-Ethnic Study of Atherosclerosis (MESA)

Journal of Physical Activity and Health ◽

10.1123/jpah.2012-0068a ◽

2014 ◽

Vol 11 (4) ◽

pp. 831-837 ◽

Cited By ~ 9

Author(s):

Paul A. McAuley ◽

Haiying Chen ◽

Duck-chul Lee ◽

Enrique Garcia Artero ◽

David A. Bluemke ◽

...

Keyword(s):

Physical Activity ◽

Insulin Resistance ◽

Waist Circumference ◽

Impaired Fasting Glucose ◽

Central Obesity ◽

Cardiometabolic Risk ◽

Fasting Glucose ◽

Reference Group ◽

Model Assessment ◽

Ethnic Study

Background:The influence of higher physical activity on the relationship between adiposity and cardiometabolic risk is not completely understood.Methods:Between 2000–2002, data were collected on 6795 Multi-Ethnic Study of Atherosclerosis (MESA) participants. Self-reported intentional physical activity in the lowest quartile (0–105 MET-minutes/week) was categorized as inactive and the upper three quartiles (123–37,260 MET-minutes/week) as active. Associations of body mass index (BMI) and waist circumference categories, stratified by physical activity status (inactive or active) with cardiometabolic risk factors (dyslipidemia, hypertension, upper quartile of homeostasis model assessment of insulin resistance [HOMA-IR] for population, and impaired fasting glucose or diabetes) were assessed using logistic regression analysis adjusting for age, gender, race/ethnicity, and current smoking.Results:Among obese participants, those who were physically active had reduced odds of insulin resistance (47% lower; P < .001) and impaired fasting glucose/diabetes (23% lower; P = .04). These associations were weaker for central obesity. However, among participants with a normal waist circumference, those who were inactive were 63% more likely to have insulin resistance (OR [95% CI] 1.63 [1.24–2.15]) compared with the active reference group.Conclusions:Physical activity was inversely related to the cardiometabolic risk associated with obesity and central obesity.

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Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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Effect of diabetes self-management education on glycaemic control among type 2 diabetic patients at a family medicine clinic in Kenya: A randomised controlled trial

African Journal of Primary Health Care & Family Medicine ◽

10.4102/phcfm.v10i1.1762 ◽

2018 ◽

Vol 10 (1) ◽

Cited By ~ 3

Author(s):

Catherine W. Gathu ◽

Jacob Shabani ◽

Nancy Kunyiha ◽

Riaz Ratansi

Keyword(s):

Family Medicine ◽

Usual Care ◽

Primary Outcome ◽

Self Management ◽

Diabetic Patients ◽

Educational Approach ◽

Medicine Clinic ◽

The Family

Background: Diabetes self-management education (DSME) is a key component of diabetes care aimed at delaying complications. Unlike usual care, DSME is a more structured educational approach provided by trained, certified diabetes educators (CDE). In Kenya, many diabetic patients are yet to receive this integral component of care. At the family medicine clinic of the Aga Khan University Hospital (AKUH), Nairobi, the case is no different; most patients lack education by CDE.Aim: This study sought to assess effects of DSME in comparison to usual diabetes care by family physicians.Setting: Family Medicine Clinic, AKUH, Nairobi.Methods: Non-blinded randomised clinical trial among sub-optimally controlled (glycated haemoglobin (HbA1c) ≥ 8%) type 2 diabetes patients. The intervention was DSME by CDE plus usual care versus usual care from family physicians. Primary outcome was mean difference in HbA1c after six months of follow-up. Secondary outcomes included blood pressure and body mass index.Results: A total of 220 diabetes patients were screened out of which 140 met the eligibility criteria and were randomised. Around 96 patients (69%) completed the study; 55 (79%) in the DSME group and 41 (59%) in the usual care group. The baseline mean age and HbA1c of all patients were 48.8 (standard deviation [SD]: 9.8) years and 9.9% (SD: 1.76%), respectively. After a 6-month follow-up, no significant difference was noted in the primary outcome (HbA1c) between the two groups, with a mean difference of 0.37 (95% confidence interval: -0.45 to 1.19; p = 0.37). DSME also made no remarkable change in any of the secondary outcome measures.Conclusion: From this study, short-term biomedical benefits of a structured educational approach seemed to be limited. This suggested that offering a short, intensified education programme might have limited additional benefit above and beyond the family physicians’ comprehensive approach in managing chronic conditions like diabetes.

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Physical activity less than the recommended amount may prevent the onset of major biological risk factors for cardiovascular disease: a cohort study of 198 919 adults

British Journal of Sports Medicine ◽

10.1136/bjsports-2018-099740 ◽

2018 ◽

Vol 54 (4) ◽

pp. 238-244 ◽

Cited By ~ 1

Author(s):

David Martinez-Gomez ◽

Irene Esteban-Cornejo ◽

Esther Lopez-Garcia ◽

Esther García-Esquinas ◽

Kabir P Sadarangani ◽

...

Keyword(s):

Physical Activity ◽

Risk Factors ◽

Type 2 Diabetes ◽

Cardiovascular Disease ◽

Cvd Risk Factors ◽

Cvd Risk ◽

Highly Active ◽

Atherogenic Dyslipidaemia

ObjectivesWe examined the dose–response relationship between physical activity (PA) and incidence of cardiovascular disease (CVD) risk factors in adults in Taiwan.MethodsThis study included 1 98 919 participants, aged 18–97 years, free of CVD, cancer and diabetes at baseline (1997–2013), who were followed until 2016. At baseline, participants were classified into five PA levels: inactive’ (0 metabolic equivalent of task (MET)-h/week), ‘lower insufficiently active’ (0.1–3.75 MET-h/week), ‘upper insufficiently active’ (3.75–7.49 MET-h/week), ‘active’ (7.5–14.99 MET-h/week) and ‘highly active’ (≥15 MET-h/week]. CVD risk factors were assessed at baseline and at follow-up by physical examination and laboratory tests. Analyses were performed with Cox regression and adjusted for the main confounders.ResultsDuring a mean follow-up of 6.0±4.5 years (range 0.5–19 years), 20 447 individuals developed obesity, 19 619 hypertension, 21 592 hypercholesterolaemia, 14 164 atherogenic dyslipidaemia, 24 275 metabolic syndrome and 8548 type 2 diabetes. Compared with inactive participants, those in the upper insufficiently active (but not active) category had a lower risk of obesity (HR 0.92; 95% CI 0.88 to 0.95), atherogenic dyslipidaemia (0.96; 0.90 to 0.99), metabolic syndrome (0.95; 0.92 to 0.99) and type 2 diabetes (0.91; 0.86 to 0.97). Only highly active individuals showed a lower incidence of CVD risk factors than their upper insufficiently active counterparts.ConclusionCompared with being inactive, doing half the recommended amount of PA is associated with a lower incidence of several common biological CVD risk factors. Given these benefits, half the recommended amount of PA is an evidence based target for inactive adults.

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A physical activity program versus usual care in the management of quality of life for pre-frail older adults with chronic pain in primary care: randomized controlled trial.

10.21203/rs.3.rs-33919/v1 ◽

2020 ◽

Author(s):

Pedro Otones ◽

Eva García ◽

Teresa Sanz ◽

Azucena Pedraz

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Older Adults ◽

Chronic Pain ◽

Usual Care ◽

Pain Intensity ◽

Physical Performance ◽

Frail Older Adults

Abstract Background Exercise have shown being effective for managing chronic pain and preventing frailty status in older adults but the effect of an exercise program in the quality of life of pre-frail older adults with chronic pain remains unclear. Our objective was to evaluate the effectiveness of multicomponent structured physical exercise program for pre-frail adults aged 65 years or more with chronic pain to improve their perceived health related quality of life, compared with usual care. Methods Open label randomized controlled trial. Participants were community-dwelling pre-frail older adults aged 65 years or older with chronic pain and non-dependent for basic activities of daily living attending a Primary Healthcare Centre. Forty-four participants were randomly allocated to a control group (n = 20) that received usual care or an intervention group (n = 24) that received an 8-week physical activity and education program. Frailty status (SHARE Frailty Index), quality of life (EuroQol-5D-5L), pain intensity (Visual Analogue Scale), physical performance (Short Physical Performance Battery) and depression (Yessavage) were assessed at baseline, after the intervention and after 3 months follow-up. The effect of the intervention was analysed by mean differences between the intervention and control groups. Results The follow-up period (3 months) was completed by 32 patients (73%), 17 in the control group and 15 in the intervention group. Most participants were women (78.1%) with a mean age (standard deviation) of 77.2 (5.9) years and a mean pain intensity of 48.1 (24.4) mm. No relevant differences were found between groups at baseline. After the intervention, mean differences in the EuroQol Index Value between control and intervention groups were significant (-0.19 95%CI(-0.33- -0.04)) and remained after three months follow-up (-0.21 95%CI(-0.37- -0.05)). Participants in the exercise group showed better results in pain intensity and frailty after the intervention, and an improvement in physical performance after the intervention and after three months. Conclusions An eight-week physical activity and education program for pre-frail older adults with chronic pain, compared with usual care, could be effective to improve quality of life after the intervention and after three-months follow-up. Study registration details: This study was retrospectively registered in ClinicalTrials.gov with the identifier NCT04045535.

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Behavioural interventions to promote physical activity in a multiethnic population at high risk of diabetes: PROPELS three-arm RCT

Health Technology Assessment ◽

10.3310/hta25770 ◽

2021 ◽

Vol 25 (77) ◽

pp. 1-190

Author(s):

Kamlesh Khunti ◽

Simon Griffin ◽

Alan Brennan ◽

Helen Dallosso ◽

Melanie Davies ◽

...

Keyword(s):

Physical Activity ◽

Type 2 Diabetes ◽

Confidence Interval ◽

Primary Outcome ◽

Health Technology ◽

Accelerometer Data ◽

Ambulatory Activity ◽

Steps Per Day

Background Type 2 diabetes is a leading cause of mortality globally and accounts for significant health resource expenditure. Increased physical activity can reduce the risk of diabetes. However, the longer-term clinical effectiveness and cost-effectiveness of physical activity interventions in those at high risk of type 2 diabetes is unknown. Objectives To investigate whether or not Walking Away from Diabetes (Walking Away) – a low-resource, 3-hour group-based behavioural intervention designed to promote physical activity through pedometer use in those with prediabetes – leads to sustained increases in physical activity when delivered with and without an integrated mobile health intervention compared with control. Design Three-arm, parallel-group, pragmatic, superiority randomised controlled trial with follow-up conducted at 12 and 48 months. Setting Primary care and the community. Participants Adults whose primary care record included a prediabetic blood glucose measurement recorded within the past 5 years [HbA1c ≥ 42 mmol/mol (6.0%), < 48 mmol/mol (6.5%) mmol/mol; fasting glucose ≥ 5.5 mmol/l, < 7.0 mmol/l; or 2-hour post-challenge glucose ≥ 7.8 mmol/l, < 11.1 mmol/l] were recruited between December 2013 and February 2015. Data collection was completed in July 2019. Interventions Participants were randomised (1 : 1 : 1) using a web-based tool to (1) control (information leaflet), (2) Walking Away with annual group-based support or (3) Walking Away Plus (comprising Walking Away, annual group-based support and a mobile health intervention that provided automated, individually tailored text messages to prompt pedometer use and goal-setting and provide feedback, in addition to biannual telephone calls). Participants and data collectors were not blinded; however, the staff who processed the accelerometer data were blinded to allocation. Main outcome measures The primary outcome was accelerometer-measured ambulatory activity (steps per day) at 48 months. Other objective and self-reported measures of physical activity were also assessed. Results A total of 1366 individuals were randomised (median age 61 years, median body mass index 28.4 kg/m2, median ambulatory activity 6638 steps per day, women 49%, black and minority ethnicity 28%). Accelerometer data were available for 1017 (74%) and 993 (73%) individuals at 12 and 48 months, respectively. The primary outcome assessment at 48 months found no differences in ambulatory activity compared with control in either group (Walking Away Plus: 121 steps per day, 97.5% confidence interval –290 to 532 steps per day; Walking Away: 91 steps per day, 97.5% confidence interval –282 to 463). This was consistent across ethnic groups. At the intermediate 12-month assessment, the Walking Away Plus group had increased their ambulatory activity by 547 (97.5% confidence interval 211 to 882) steps per day compared with control and were 1.61 (97.5% confidence interval 1.05 to 2.45) times more likely to achieve 150 minutes per week of objectively assessed unbouted moderate to vigorous physical activity. In the Walking Away group, there were no differences compared with control at 12 months. Secondary anthropometric, biomechanical and mental health outcomes were unaltered in either intervention study arm compared with control at 12 or 48 months, with the exception of small, but sustained, reductions in body weight in the Walking Away study arm (≈ 1 kg) at the 12- and 48-month follow-ups. Lifetime cost-effectiveness modelling suggested that usual care had the highest probability of being cost-effective at a threshold of £20,000 per quality-adjusted life-year. Of 50 serious adverse events, only one (myocardial infarction) was deemed possibly related to the intervention and led to the withdrawal of the participant from the study. Limitations Loss to follow-up, although the results were unaltered when missing data were replaced using multiple imputation. Conclusions Combining a physical activity intervention with text messaging and telephone support resulted in modest, but clinically meaningful, changes in physical activity at 12 months, but the changes were not sustained at 48 months. Future work Future research is needed to investigate which intervention types, components and features can help to maintain physical activity behaviour change over the longer term. Trial registration Current Controlled Trials ISRCTN83465245. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 77. See the NIHR Journals Library website for further project information.

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Metabolic Syndrome and Ethnic Groups Second edition

10.26415/978-9931-9446-4-5 ◽

2021 ◽

Author(s):

Mohammadhosain Afrand ◽

Mohammad Afkhami-Ardekani ◽

Ahmad Shojaoddiny-Ardekani ◽

Azita Ariaeinejad

Keyword(s):

Physical Activity ◽

Risk Factors ◽

Type 2 Diabetes ◽

Metabolic Syndrome ◽

Preventive Measures ◽

Lifestyle Modification ◽

Treatment Strategies ◽

Subsequent Development ◽

Metabolic Risk

Metabolic syndrome is defined as the co-occurrence of metabolic risk factors for both type 2 diabetes and cardiovascular disease (i.e. abdominal obesity, hyperglycemia, dyslipidemia, and hypertension). Indeed, metabolic syndrome is an important risk factor for subsequent development of type 2 diabetes and/or CVD. Thus, the key clinical implication of a diagnosis of metabolic syndrome is the identification of a patient who needs aggressive lifestyle modification focused on weight reduction and increased physical activity. Multiple different phenotypes and ethnic-specific values for waist circumference are included within metabolic syndrome, with indications for differing treatment strategies. This book covers several aspects of metabolic syndrome, including its definition, diagnostic criteria, preventive measures, and treatment, as well as the possible association between ethnicity and the occurrence of metabolic syndrome.

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