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

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.

Abstract 018: Association of the Change in Physical Activity and Cardiovascular Disease Outcomes in the Look AHEAD Trial

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
John M Jakicic ◽  
Janet E Fulton ◽  
Wei Lang ◽  
Michael P Walkup
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Look Ahead ◽  
The Look ◽  
Fatal Myocardial Infarction

Introduction: The Look AHEAD trial examined cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention compared to those randomly assigned to diabetes support and education (control). In a substudy, physical activity was assessed using accelerometry, which provides an opportunity to examine whether the incidence of cardiovascular disease varied by the measured change in physical activity. Hypothesis: There is a beneficial association between the 1- and 4-year change in physical activity and the pre-specified primary and secondary outcomes in participants in the Look AHEAD trial. Methods: Adults (N=1,978; 59.1±6.8 kg; 102.8±19.0 kg) with type 2 diabetes at 8 study sites, who completed physical activity was assessment using accelerometry for 1 week at 0, 1, and 4 years. MET-minutes per week of moderate-to-vigorous physical activity (MVPA) performed in bouts of at least 10 minutes was identified from the accelerometry data. The 1- and 4-year change in MVPA was computed as the difference from baseline. The primary outcome was pre-defined as non-fatal myocardial infarction, stroke, hospitalized angina, and cardiovascular disease death. The first secondary outcome was pre-defined as non-fatal myocardial infarction, stroke, hospitalized angina, CABG/PTCA, hospitalized congestive heart failure, carotid endarterectomy, peripheral vascular disease, and total mortality. The relationships between 1- and 4-year change in physical activity and the primary and secondary outcomes were examined using Cox proportional hazards models with data collapses across the two treatment groups. Hazard ratios (HR) were adjusted for age, sex, history of cardiovascular disease, duration of diabetes, diabetes medication use, baseline weight, change in weight, and baseline physical activity. Results: MVPA [Median (25 th , 75 th percentile)] was 167.6 (0,545.5), 205.4 (0, 700.2), and 91.3 (0, 418.9) MET-minutes per week at 0, 1 and 4 years, respectively. Change in MVPA at 1-year was not significantly associated with the primary outcome [HR per 100 MET-minutes per week = 1.001 (95% CI: 0.985, 1.017)] or secondary outcome [HR per 100 MET-minutes per week = 0.989 (95% CI: 0.966, 1.013)] assessed across 8.8±2.4 years of follow-up. Change in MVPA at 4-years was significantly associated with a reduction in the primary [HR per 100 MET-minutes per week = 0.949 (95% CI: 0.912, 0.987)] and the secondary outcome [HR per 100 MET-minutes per week = 0.897 (95% CI: 0.843, 0.954)] assessed across 9.2±1.8 years of follow-up. Conclusions: Change in physical activity at 4-years is associated with a reduction in incidence of cardiovascular disease in adults with type 2 diabetes. These findings suggest improvements in physical activity may need to be sustained for a relatively long period (4 years) to elicit a beneficial effect on incidence of cardiovascular disease.

scholarly journals Promoting physical activity in a multi-ethnic population at high risk of diabetes: the 48-month PROPELS randomised controlled trial

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Kamlesh Khunti ◽  
Simon Griffin ◽  
Alan Brennan ◽  
Helen Dallosso ◽  
Melanie J. Davies ◽  
...  
Keyword(s):  
Physical Activity ◽  
Text Messaging ◽  
Primary Outcome ◽  
Vigorous Physical Activity ◽  
Text Messages ◽  
Analysis Of Covariance ◽  
Accelerometer Data ◽  
Ambulatory Activity ◽  
Mhealth Intervention

Abstract Background Physical activity is associated with a reduced risk of type 2 diabetes and cardiovascular disease but limited evidence exists for the sustained promotion of increased physical activity within diabetes prevention trials. The aim of the study was to investigate the long-term effectiveness of the Walking Away programme, an established group-based behavioural physical activity intervention with pedometer use, when delivered alone or with a supporting mHealth intervention. Methods Those at risk of diabetes (nondiabetic hyperglycaemia) were recruited from primary care, 2013–2015, and randomised to (1) Control (information leaflet); (2) Walking Away (WA), a structured group education session followed by annual group-based support; or (3) Walking Away Plus (WAP), comprising WA annual group-based support and an mHealth intervention delivering tailored text messages supported by telephone calls. Follow-up was conducted at 12 and 48 months. The primary outcome was accelerometer measured ambulatory activity (steps/day). Change in primary outcome was analysed using analysis of covariance with adjustment for baseline, randomisation and stratification variables. Results One thousand three hundred sixty-six individuals were randomised (median age = 61 years, ambulatory activity = 6638 steps/day, women = 49%, ethnic minorities = 28%). Accelerometer data were available for 1017 (74%) individuals at 12 months and 993 (73%) at 48 months. At 12 months, WAP increased their ambulatory activity by 547 (97.5% CI 211, 882) steps/day compared to control and were 1.61 (97.5% CI 1.05, 2.45) times more likely to achieve 150 min/week of moderate-to-vigorous physical activity. Differences were not maintained at 48 months. WA was no different to control at 12 or 48 months. Secondary anthropometric and health outcomes were largely unaltered in both intervention groups apart from small reductions in body weight in WA (~ 1 kg) at 12- and 48-month follow-up. Conclusions Combining a pragmatic group-based intervention with text messaging and telephone support resulted in modest changes to physical activity at 12 months, but changes were not maintained at 48 months. Trial registration ISRCTN 83465245 (registered on 14 June 2012).

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

2018 ◽  
Vol 54 (4) ◽  
pp. 238-244 ◽  
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.

scholarly journals Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036277 ◽  
Author(s):  
Kaushik Chattopadhyay ◽  
Pallavi Mishra ◽  
Kavita Singh ◽  
Tess Harris ◽  
Mark Hamer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
High Risk ◽  
Randomised Controlled Trial ◽  
Plasma Glucose ◽  
Plasma Glucose Level ◽  
Controlled Trial ◽  
Randomised Controlled

IntroductionA huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.InterventionYOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.Methods and analysisThis is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18–74 years, at high risk of T2DM (fasting plasma glucose level 5.6–6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20–30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.Ethics and disseminationEthics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration numberCTRI/2019/05/018893.

Walking: a matter of quantity and quality physical activity for type 2 diabetes management

2008 ◽  
Vol 33 (4) ◽  
pp. 797-801 ◽  
Author(s):  
Steven T. Johnson ◽  
Normand G. Boulé ◽  
Gordon J. Bell ◽  
Rhonda C. Bell
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Clinical Practice ◽  
Health Outcomes ◽  
Walking Speed ◽  
Diabetes Management ◽  
Health Benefit ◽  
Current Clinical Practice ◽  
Steps Per Day

Walking is often prescribed as a mode of physical activity for people with type 2 diabetes (T2D). We and others have found that although people with T2D may increase the amount that they walk (e.g., more steps per day), improvements in key health outcomes are rarely achieved. We agree that walking is an acceptable approach for people with T2D to meet current clinical practice guidelines, but consideration of both the total number of daily steps and the walking speed of a portion of those total daily steps are necessary to gain health benefit.

scholarly journals Effects of a three-armed randomised controlled trial using self-monitoring of daily steps with and without counselling in prediabetes and type 2 diabetes—the Sophia Step Study

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Jenny Rossen ◽  
Kristina Larsson ◽  
Maria Hagströmer ◽  
Agneta Yngve ◽  
Kerstin Brismar ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Single Component ◽  
Control Group ◽  
Self Monitoring ◽  
Randomised Controlled ◽  
Step Study

Abstract Background This aimed to evaluate the effects of self-monitoring of daily steps with or without counselling support on HbA1c, other cardiometabolic risk factors and objectively measured physical activity (PA) during a 2-year intervention in a population with prediabetes or type 2 diabetes. Methods The Sophia Step Study was a three-armed parallel randomised controlled trial. Participants with prediabetes or type 2 diabetes were recruited in a primary care setting. Allocation (1:1:1) was made to a multi-component intervention (self-monitoring of steps with counselling support), a single-component intervention (self-monitoring of steps without counselling support) or standard care. Data were collected for primary outcome HbA1c at baseline and month 6, 12, 18 and 24. Physical activity was assessed as an intermediate outcome by accelerometer (ActiGraph GT1M) for 1 week at baseline and the 6-, 12-, 18- and 24-month follow-up visits. The intervention effects were evaluated by a robust linear mixed model. Results In total, 188 subjects (64, 59, 65 in each group) were included. The mean (SD) age was 64 (7.7) years, BMI was 30.0 (4.4) kg/m2 and HbA1c was 50 (11) mmol/mol, 21% had prediabetes and 40% were female. The dropout rate was 11% at 24 months. Effect size (CI) for the primary outcome (HbA1c) ranged from -1.3 (-4.8 to 2.2) to 1.1 (-2.4 to 4.6) mmol/mol for the multi-component vs control group and from 0.3 (-3.3 to 3.9) to 3.1 (-0.5 to 6.7) mmol/mol for the single-component vs control group. Effect size (CI) for moderate-to-vigorous physical activity ranged from 8.0 (0.4 to 15.7) to 11.1 (3.3 to 19.0) min/day for the multi-component vs control group and from 7.6 (-0.4 to 15.6) to 9.4 (1.4 to 17.4) min/day for the single-component group vs control group. Conclusion This 2-year intervention, including self-monitoring of steps with or without counselling, prevented a decrease in PA but did not provide evidence for improved metabolic control and cardiometabolic risk factors in a population with prediabetes or type 2 diabetes. Trial registration ClinicalTrials.gov, NCT02374788. Registered 2 March 2015—Retrospectively registered.

scholarly journals Prognostic Value of Secreted Frizzled-Related Protein 5 in Heart Failure Patients With and Without Type 2 Diabetes Mellitus

2020 ◽  
Vol 13 (9) ◽  
Author(s):  
Jiandi Wu ◽  
Haoxiao Zheng ◽  
Xinyue Liu ◽  
Peisong Chen ◽  
Yunlong Zhang ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Heart Failure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Prognostic Value ◽  
Primary Outcome ◽  
Related Protein

Background: Patients with heart failure (HF) with diabetes mellitus have distinct biomarker profiles compared with those without diabetes mellitus. SFRP5 (secreted frizzled-related protein 5) is an anti-inflammatory adipokine with an important suppressing role on the development of type 2 diabetes mellitus (T2DM). This study aimed to evaluate the prognostic value of SFRP5 in patients with HF with and without T2DM. Methods: The study included 833 consecutive patients with HF, 312 (37.5%) of whom had T2DM. Blood samples were collected at presentation, and SFRP5 levels were measured. The primary outcome was the composite end points of first occurrence of HF rehospitalization or all-cause mortality during follow-up. Results: During median follow-up of 2.1 years, 335 (40.2%) patients in the cohort experienced the composite primary outcome. After adjustment for multiple risk factors, each doubling of SFRP5 level was associated with a 21% decreased risk of primary outcomes in the overall study population ( P <0.001). Subgroup analyses showed that the association between level of SFPR5 and primary outcomes may be stronger in patients with T2DM (hazard ratio, 0.69 [95% CI, 0.61–0.79]) than in patients without T2DM (hazard ratio, 0.89 [95% CI, 0.79–1.01]; interaction P =0.006). Similar associations were observed when taking SFRP5 as a categorical variable. Addition of SFRP5 significantly improved discrimination and reclassification of the incident primary outcomes beyond clinical risk factors and N-terminal pro-B-type natriuretic peptide in all patients with HF and those with T2DM (all P <0.01). Conclusions: SFRP5 is an independent novel biomarker for risk stratification in HF, especially in HF with T2DM.

scholarly journals Type 2 diabetes, healthcare expenditures and its correlation with anthropometric factors and physical activity: 18-month follow-up in a Brazilian city

2018 ◽  
Vol 24 (1) ◽  
Author(s):  
Monique Yndawe Castanho Araujo ◽  
Bruna Camilo Turi ◽  
Dayane Cristina Queiroz ◽  
Izabela dos Santos Ferro ◽  
Carolina Rodrigues Bortolatto ◽  
...  
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Healthcare Expenditures

Two Physical Activity Measures: Paffenbarger Physical Activity Questionnaire Versus Aerobics Center Longitudinal Study as Predictors of Adult-Onset Type 2 Diabetes in a Follow-Up Study

2017 ◽  
Vol 32 (4) ◽  
pp. 1070-1077 ◽  
Author(s):  
Serena Tonstad ◽  
Patti Herring ◽  
Jerry Lee ◽  
Jennifer Duxbury Johnson
Keyword(s):  
Physical Activity ◽  
Type 2 Diabetes ◽  
Longitudinal Study ◽  
Adult Onset ◽  
Physical Activity Questionnaire ◽  
Onset Type ◽  
Aerobics Center Longitudinal Study ◽  
Activity Questionnaire

Purpose: To compare 2 self-report methods of measuring weekly minutes of physical activity based on the Aerobics Center Longitudinal Study (ACLS) questionnaire and question 6 of the Paffenbarger Physical Activity Questionnaire (PPAQ) to determine the better predictor of adult-onset type 2 diabetes mellitus (T2DM). Design: An observational, prospective study. Setting: Survey data from the Adventist Health Study-2 (AHS-2) collected between 2002 and 2006 (baseline) and the Psychosocial Manifestations of Religion Sub-Study (PsyMRS), an AHS-2 subset collected 1 to 4 years later. Patients: Nine thousand eight hundred seventy-three male and female participants aged 23 to 106 years (mean, 63 years). Three hundred eighty participants reported adult-onset T2DM at follow-up. Measures: Question 6 from the PPAQ and a question adopted from the ACLS were assessed at baseline. Incident diabetes was defined as participants who reported receiving treatment for adult-onset T2DM in the last 12 months in the PsyMRS and not at baseline. Analysis: Multivariate logistic regression analyses controlled for age, gender, ethnicity, education, body mass index (BMI), diet, and sedentary activity. Each exposure variable was compared to nonexercisers. Results: The PPAQ (odds ratio [OR]: 0.998; 95% confidence interval [CI]: 0.997-1.000) and the ACLS (OR: 0.999; 95% CI: 0.998-1.001) exhibited similar likelihood of predicting incident adult-onset T2DM in a healthy, mixed-gender population when controlling for several confounders. Conclusions: The demonstrative nomenclature of the PPAQ may be more effectual in capturing physically active individuals than the ACLS notwithstanding generalizability and response bias limitations.

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