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 ◽  
...  

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).

2021 ◽  
Vol 25 (77) ◽  
pp. 1-190
Author(s):  
Kamlesh Khunti ◽  
Simon Griffin ◽  
Alan Brennan ◽  
Helen Dallosso ◽  
Melanie Davies ◽  
...  

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.


2021 ◽  
Vol 12 ◽  
Author(s):  
Corina Berli ◽  
Urte Scholz

Keeping a physically active lifestyle requires consistent self-regulatory effort such as action control (e.g., continuously monitoring and evaluating a behavior in terms of one’s goals). Involving the romantic partner in interventions might be particularly effective in the long run. The present study examined the long-term and transfer effects of an action control intervention in couples using text messaging for promoting target persons’ and partners’ physical activity, anthropometric measures and physical fitness 6 months post baseline. A total of 121 overweight and obese romantic couples, randomly allocated to an intervention (n = 60; information + action control text messages) or a control group (n = 61; information only) and to participating as target person or partner, completed baseline assessments (T1). 100 couples (82.6%) completed the 6-month follow-up (T3) assessment. Primary outcomes included self-reported moderate-to-vigorous physical activity (MVPA) and objective MVPA and MVPA adherence using triaxial accelerometers across a diary period of 14 days after T3. Secondary outcomes included BMI, waist-to-hip circumference and physical fitness (target persons only) using a submaximal aerobic cycle test. At T3, there were no significant between-group differences between target persons and partners with regard to their objective MVPA, self-reported MVPA, BMI, waist-hip ratio or physical fitness. No significant changes in outcomes were observed from T1 to T3; however, changes in BMI from T1 to T3 between target persons and partners in the intervention group were associated. Overall, the brief 14-days action control intervention was not effective in improving target person’s physical activity, body measures and physical fitness in the long-term. Moreover, no long-term benefits for partners emerged. While brief ecological momentary interventions might be a promising tool for short-term effects, future studies are needed to test features enhancing long-term effectiveness. Associations in romantic partners’ changes suggest that dyadic interventions can be a promising approach, as changes induced in one partner may then transfer over to the other (controlled-trials.com ISRCTN15705531).


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
X H Huo ◽  
H M K Krumholz ◽  
X B Bai ◽  
E S S Spatz ◽  
Q D Ding ◽  
...  

Abstract Background Mobile health interventions hold the prospect to support risk factor and lifestyle modification and are readily scalable in healthcare systems. Purpose We aim to assess whether text messaging program can improve glycemic control in high-risk patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods The study was a multi-centre randomised clinical trial conducted at 34 clinics in China. 502 individuals with both CHD and DM were recruited and randomly assigned to either the text messaging intervention (n=251) or control group (n=251). The control group received 2 thank-you messages per month in addition to usual care. The intervention group received 6 messages per week for 6 months. Messages provided educational and motivational information related to glucose monitoring, BP control, physical activity and lifestyle recommendations. The primary outcome was change in glycemic hemoglobin (HbA1C) from baseline to 6 months. Results Follow-up rate was 99%. At 6 months, HbA1C was significantly lower in intervention group compared to control group (mean HbA1C 6.7% vs. 7.2%, P<0.001), with a mean change of −0.2% and 0.1% from baseline, respectively (mean absolute change −0.3% [95% CI −0.5 to 0.1]; P=0.003). Significantly more participants in intervention group achieved a HbA1c<7% (69.3% vs. 52.6%; P=0.004), and change in FBG was larger in intervention group (−0.5 vs. 0.1 mmol/L; P=0.011). No differences in SBP, LDL-C, BMI and physical activity were observed. Almost all patients reported messages to be easy to understand (97.1%) and useful (94.1%). Table 1. Primary and Secondary Outcomes Analyses at 6 Month Follow-up Parameter Intervention (N=251) Control (N=251) Mean Difference in Change P value for Baseline 6 Months Mean Change Baseline 6 Months Mean Change (95% CI) Difference in Change Primary Outcome HbA1C level, %, mean (SD) 6.9 (1.4) 6.7 (1.3) −0.2 (1.0) 7.1 (1.4) 7.2 (1.5) 0.1 (1.1) −0.3 (−0.5, −0.1) 0.003 Secondary Outcomes HbA1C level<7%, No. (%) 155 (62.0%) 174 (69.3%) – 139 (56.1%) 132 (52.6%) – 1.2 (1.1, 1.3)a 0.004   FBG, mmol/L, mean (SD) 8.1 (2.7) 7.5 (2.7) −0.5 (2.5) 8.5 (3.0) 8.6 (3.3) 0.1 (3.1) −0.6 (−1.1, −0.2) 0.011   SBP, mmHg, mean (SD) 135.9 (18.4) 134.7 (18.7) −1.4 (17.1) 135.9 (18.1) 132.2 (17.7) −3.5 (17.8) 2.4 (−0.8,5.5) 0.144   LDL-C, mmol/L, mean (SD) 2.6 (0.8) 2.5 (0.7) −0.1 (0.7) 2.6 (0.8) 2.5 (0.8) −0.1 (0.7) 0 (−0.1, 0.1) 0.828   BMI, mean (SD) 26.4 (3.2) 26.3 (3.5) −0.1 (2.1) 26.3 (3.2) 26.0 (3.4) −0.4 (2.5) 0.3 (−0.1, 0.7) 0.213   Physical activity (MET min/wk), 1386 1386 177 1386 1386 322 −70.7 0.784     median (IQR) (693–3066) (918–3612) (2840) (693–3066) (693–3002) (2635) (−574.9, 433.5) Conclusion Use of a simple, culturally sensitive mobile text-messaging program could be an effective and scalable way to improve disease self-management among patients with CHD and DM. Acknowledgement/Funding Research Special Fund for Public Welfare Industry of Health (201502009) from the National Health and Family Planning Commission of China


BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018302 ◽  
Author(s):  
Xiqian Huo ◽  
Erica S Spatz ◽  
Qinglan Ding ◽  
Paul Horak ◽  
Xin Zheng ◽  
...  

IntroductionMobile health interventions have the potential to promote risk factor management and lifestyle modification, and are a particularly attractive approach for scaling across healthcare systems with limited resources. We are conducting two randomised trials to evaluate the efficacy of text message-based health messages in improving secondary coronary heart disease (CHD) prevention among patients with or without diabetes.Methods and analysisThe Cardiovascular Health And Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study are multicentre, single-blind, randomised controlled trials of text messaging versus standard treatment with 6 months of follow-up conducted in 37 hospitals throughout 17 provinces in China. The intervention group receives six text messages per week which target blood pressure control, medication adherence, physical activity, smoking cessation (when appropriate), glucose monitoring and lifestyle recommendations including diet (in CHAT-DM). The text messages were developed based on behavioural change techniques, using models such as the information-motivation-behavioural skills model, goal setting and provision of social support. A total sample size of 800 patients would be adequate for CHAT Study and sample size of 500 patients would be adequate for the CHAT-DM Study. In CHAT, the primary outcome is the change in systolic blood pressure (SBP) at 6 months. Secondary outcomes include a change in proportion of patients achieving a SBP <140 mm Hg, low-density lipoprotein cholesterol (LDL-C), physical activity, medication adherence, body mass index (BMI) and smoking cessation. In CHAT-DM, the primary outcome is the change in glycaemic haemoglobin (HbA1C) at 6 months. Secondary outcomes include a change in the proportion of patients achieving HbA1C<7%, fasting blood glucose, SBP, LDL-C, BMI, physical activity and medication adherence.Ethics and disseminationThe central ethics committee at the China National Center for Cardiovascular Disease and the Yale University Institutional Review Board approved the CHAT and CHAT-DM studies. Results will be disseminated via usual scientific forums including peer-reviewed publications.Trial registration numberCHAT (NCT02888769) and CHAT-DM (NCT02883842); Pre-results.


2020 ◽  
Vol 76 (1) ◽  
pp. 77-84
Author(s):  
Purva Jain ◽  
John Bellettiere ◽  
Nicole Glass ◽  
Michael J LaMonte ◽  
Chongzhi Di ◽  
...  

Abstract Background Self-reported time spent standing has been associated with lower risk of mortality. No previous studies have examined this association using device-measured standing. Method This was a prospective cohort study of 5878 older (median age = 80 years), racial/ethnically diverse, community-dwelling women in the WHI Objective Physical Activity and Cardiovascular Health Study (OPACH). Women wore accelerometers for 1 week and were followed for mortality. The study applied previously validated machine learning algorithms to ActiGraph GT3X+ accelerometer data to separately measure time spent standing with and without ambulation. Cox proportional hazards models were used to estimate mortality risk adjusting for potential confounders. Effect modification by age, body mass index, moderate-to-vigorous physical activity, sedentary time, physical functioning, and race/ethnicity was evaluated. Results There were 691 deaths during 26 649 person-years of follow-up through March 31, 2018 (mean follow-up = 4.8 years). In fully adjusted models, all-cause mortality risk was lower among those with more standing without ambulation (quartile [Q] 4 vs Q1 HR = 0.63; 95% CI = 0.49–0.81, p-trend = .003) and more standing with ambulation (Q4 vs Q1 HR = 0.50; 95% CI = 0.35–0.71, p-trend &lt; .001). Associations of standing with ambulation and mortality were stronger among women with above-median sedentary time (HR = 0.51; 95% CI = 0.38–0.68) compared to women with below-median sedentary time (HR = 0.80; 95% CI = 0.59–1.07; p-interaction = .02). Conclusions In this prospective study among older women, higher levels of accelerometer-measured standing were associated with lower risks of all-cause mortality. Standing is an achievable approach to interrupting prolonged sedentary time, and if not contraindicated, is a safe and feasible behavior that appears to benefit health in older ages.


2020 ◽  
Vol 28 (2) ◽  
pp. 255-261
Author(s):  
Quinn Malone ◽  
Steven Passmore ◽  
Michele Maiers

Different techniques used to analyze and reduce accelerometer data may impact its interpretation. To determine which variables were impacted by changing analysis parameters, the authors performed a secondary analysis of data gained from a clinical trial conducted on older adults (aged ≥65 years; M = 71.1 and SD = 5.3; n = 100) with neck and back disabilities and compared the effects of two different cut- point sets (Matthews and Freedson sets) commonly used to analyze older adult accelerometry data. The Matthews set was found to assign significantly greater moderate-to-vigorous physical activity per day than the Freedson set in all comparisons. This suggests that, if moderate-to-vigorous physical activity per unit time is a primary outcome measure, the choice of which analysis method is used should be carefully considered. Further results from analyses of dependent variables, time in moderate-to-vigorous physical activity bouts of >10 min/day, mean bout length, and number of bouts per day are discussed.


Author(s):  
Giulia Foccardi ◽  
Marco Vecchiato ◽  
Daniel Neunhaeuserer ◽  
Michele Mezzaro ◽  
Giulia Quinto ◽  
...  

Although the efficacy of cardiac rehabilitation (CR) is proven, the need to improve patients’ adherence has emerged. There are only a few studies that have investigated the effect of sending text messages after a CR period to stimulate subjects’ ongoing engagement in regular physical activity (PA). A randomized controlled pilot trial was conducted after CR, sending a daily PA text message reminder to an intervention group (IG), which was compared with a usual care control group (CG) during three months of follow-up. Thirty-two subjects were assessed pre- and post-study intervention with GPAQ, submaximal iso-watt exercise testing, a 30 s sit-to-stand test, a bilateral arm curl test, and a final survey on a seven-point Likert scale. A statistically significant difference in the increase of moderate PA time (Δ 244.7 (95% CI 189.1, 300.4) minutes, p < 0.001) and in the reduction of sedentary behavior time (Δ −77.5 (95% CI 104.9, −50.1) minutes, p = 0.004) was shown when the IG was compared with the CG. This was associated with an improvement in heart rate, blood pressure, and patients’ Borg rating on the category ratio scale 10 (CR10) in iso-watt exercise testing (all p < 0.05). Furthermore, only the IG did not show a worsening of the strength parameters in the follow-up leading to a change of the 30 s sit-to-stand test with a difference of +2.2 (95% CI 1.23, 3.17) repetitions compared to CG (p = 0.03). The telemedical intervention has been appreciated by the IG, whose willingness to continue with regular PA emerged to be superior compared to the CG. Text messages are an effective and inexpensive adjuvant after phase 2 CR that improves adherence to regular PA. Further studies are needed to confirm these results in a larger patient population and in the long term.


Author(s):  
Chih-Hsiang Yang ◽  
Jaclyn P Maher ◽  
Aditya Ponnada ◽  
Eldin Dzubur ◽  
Rachel Nordgren ◽  
...  

Abstract People differ from each other to the extent to which momentary factors, such as context, mood, and cognitions, influence momentary health behaviors. However, statistical models to date are limited in their ability to test whether the association between two momentary variables (i.e., subject-level slopes) predicts a subject-level outcome. This study demonstrates a novel two-stage statistical modeling strategy that is capable of testing whether subject-level slopes between two momentary variables predict subject-level outcomes. An empirical case study application is presented to examine whether there are differences in momentary moderate-to-vigorous physical activity (MVPA) levels between the outdoor and indoor context in adults and whether these momentary differences predict mean daily MVPA levels 6 months later. One hundred and eight adults from a multiwave longitudinal study provided 4 days of ecological momentary assessment (during baseline) and accelerometry data (both at baseline and 6 month follow-up). Multilevel data were analyzed using an open-source program (MixWILD) to test whether momentary strength between outdoor context and MVPA during baseline was associated with average daily MVPA levels measured 6 months later. During baseline, momentary MVPA levels were higher in outdoor contexts as compared to indoor contexts (b = 0.07, p &lt; .001). Participants who had more momentary MVPA when outdoors (vs. indoors) during baseline (i.e., a greater subject-level slope) had higher daily MVPA at the 6 month follow-up (b = 0.09, p &lt; .05). This empirical example shows that the subject-level momentary association between specific context (i.e., outdoors) and health behavior (i.e., physical activity) may contribute to overall engagement in that behavior in the future. The demonstrated two-stage modeling approach has extensive applications in behavioral medicine to analyze intensive longitudinal data collected from wearable sensors and mobile devices.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Wei Huang ◽  
Xiangrong Shi ◽  
Yujie Wang ◽  
Xiaoling Li ◽  
Pengpeng Gao ◽  
...  

Abstract Background Physical activity has many health benefits for children and adolescents. However, the prevalence of physical inactivity in school-aged children and adolescents remains high in China. Many factors impact the levels of moderate and vigorous physical activity (MVPA) among students. This study investigated the factors associated with students’ MVPA levels and the determinants of changes in their MVPA behaviour. Methods This is a longitudinal study with a 12-month follow-up. The study samples were obtained from 2016 and 2017 Physical Activity and Fitness in China—The Youth Study, and they included 1597 students (aged 9–18 years) from 31 primary, junior high, and high schools in Ningxia Province. Factors related to the individual (Age, Sex, BMI and attitude to PA), school (school exercise facility, PE class, teacher support, PA time and PA environment) and neighbourhood (free skill training, sport events, sport organization, sport facility) factors were measured via questionnaire at baseline and after 12 months. Multiple logistic regression was performed to examine the factors that impact students’ MVPA level and the determinants of changes in students’ MVPA behaviour. Results There was no difference in students’ MVPA levels between 2016 and 2017. Boys were more physically active than girls at baseline (RR 1.55, 95% CI 1.10, 2.20). Neighbourhood factors associated students’ MVPA levels were significant, but all of these factors (neighbourhood sport events, organizations, facilities, etc.) were removed from the longitudinal model. Individual and school factors were important for students’ MVPA maintenance and positive development (e.g., gender, attitude, school PE class and PA time). Conclusions In conclusion, both neighbourhood and school factors may affect students’ MVPA, but school appears to plays a more critical role in maintaining and promoting students’ MVPA levels. In addition, individual factors may be more important than school and neighbourhood factors in influencing students’ MVPA levels. Our research demonstrates that students’ attitudes towards PA and school factors should be considered targets for future intervention programmes to promote MVPA. More education programmes may help enhance students’ attitudes towards PA, but more studies with large samples and objective assessments are needed to explore the determinants of MVPA.


Author(s):  
Keith Brazendale ◽  
◽  
Michael W. Beets ◽  
Bridget Armstrong ◽  
R. Glenn Weaver ◽  
...  

Abstract Purpose The Structured Days Hypothesis (SDH) posits that children’s behaviors associated with obesity – such as physical activity – are more favorable on days that contain more ‘structure’ (i.e., a pre-planned, segmented, and adult-supervised environment) such as school weekdays, compared to days with less structure, such as weekend days. The purpose of this study was to compare children’s moderate-to-vigorous physical activity (MVPA) levels on weekdays versus weekend days using a large, multi-country, accelerometer-measured physical activity dataset. Methods Data were received from the International Children’s Accelerometer Database (ICAD) July 2019. The ICAD inclusion criteria for a valid day of wear, only non-intervention data (e.g., baseline intervention data), children with at least 1 weekday and 1 weekend day, and ICAD studies with data collected exclusively during school months, were included for analyses. Mixed effects models accounting for the nested nature of the data (i.e., days within children) assessed MVPA minutes per day (min/day MVPA) differences between weekdays and weekend days by region/country, adjusted for age, sex, and total wear time. Separate meta-analytical models explored differences by age and country/region for sex and child weight-status. Results/findings Valid data from 15 studies representing 5794 children (61% female, 10.7 ± 2.1 yrs., 24% with overweight/obesity) and 35,263 days of valid accelerometer data from 5 distinct countries/regions were used. Boys and girls accumulated 12.6 min/day (95% CI: 9.0, 16.2) and 9.4 min/day (95% CI: 7.2, 11.6) more MVPA on weekdays versus weekend days, respectively. Children from mainland Europe had the largest differences (17.1 min/day more MVPA on weekdays versus weekend days, 95% CI: 15.3, 19.0) compared to the other countries/regions. Children who were classified as overweight/obese or normal weight/underweight accumulated 9.5 min/day (95% CI: 6.9, 12.2) and 10.9 min/day (95% CI: 8.3, 13.5) of additional MVPA on weekdays versus weekend days, respectively. Conclusions Children from multiple countries/regions accumulated significantly more MVPA on weekdays versus weekend days during school months. This finding aligns with the SDH and warrants future intervention studies to prioritize less-structured days, such as weekend days, and to consider providing opportunities for all children to access additional opportunities to be active.


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