scholarly journals An Internet-Based Intervention Augmented With a Diet and Physical Activity Consultation to Decrease the Risk of Dementia in At-Risk Adults in a Primary Care Setting: Pragmatic Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Kaarin J Anstey ◽  
Nicolas Cherbuin ◽  
Sarang Kim ◽  
Mitchell McMaster ◽  
Catherine D'Este ◽  
...  

BACKGROUND There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. OBJECTIVE This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. METHODS A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m<sup>2</sup> or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician–led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF). RESULTS Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means −3.86, 95% CI −6.81 to −0.90, <i>P</i>=.01; week 18: difference in means −4.05, 95% CI −6.81 to −1.28, <i>P</i>&lt;.001; week 36: difference in means −4.99, 95% CI −8.04 to −1.94, <i>P</i>&lt;.001; and week 62: difference in means −4.62, 95% CI −7.62 to −1.62, <i>P</i>&lt;.001). CONCLUSIONS A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results. CLINICALTRIAL Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.

10.2196/19431 ◽  
2020 ◽  
Vol 22 (9) ◽  
pp. e19431
Author(s):  
Kaarin J Anstey ◽  
Nicolas Cherbuin ◽  
Sarang Kim ◽  
Mitchell McMaster ◽  
Catherine D'Este ◽  
...  

Background There is a need to develop interventions to reduce the risk of dementia in the community by addressing lifestyle factors and chronic diseases over the adult life course. Objective This study aims to evaluate a multidomain dementia risk reduction intervention, Body Brain Life in General Practice (BBL-GP), targeting at-risk adults in primary care. Methods A pragmatic, parallel, three-arm randomized trial involving 125 adults aged 18 years or older (86/125, 68.8% female) with a BMI of ≥25 kg/m2 or a chronic health condition recruited from general practices was conducted. The arms included (1) BBL-GP, a web-based intervention augmented with an in-person diet and physical activity consultation; (2) a single clinician–led group, Lifestyle Modification Program (LMP); and (3) a web-based control. The primary outcome was the Australian National University Alzheimer Disease Risk Index Short Form (ANU-ADRI-SF). Results Baseline assessments were conducted on 128 participants. A total of 125 participants were randomized to 3 groups (BBL-GP=42, LMP=41, and control=42). At immediate, week 18, week 36, and week 62 follow-ups, the completion rates were 43% (18/42), 57% (24/42), 48% (20/42), and 48% (20/42), respectively, for the BBL-GP group; 71% (29/41), 68% (28/41), 68% (28/41), and 51% (21/41), respectively, for the LMP group; and 62% (26/42), 69% (29/42), 60% (25/42), and 60% (25/42), respectively, for the control group. The primary outcome of the ANU-ADRI-SF score was lower for the BBL-GP group than the control group at all follow-ups. These comparisons were all significant at the 5% level for estimates adjusted for baseline differences (immediate: difference in means −3.86, 95% CI −6.81 to −0.90, P=.01; week 18: difference in means −4.05, 95% CI −6.81 to −1.28, P<.001; week 36: difference in means −4.99, 95% CI −8.04 to −1.94, P<.001; and week 62: difference in means −4.62, 95% CI −7.62 to −1.62, P<.001). Conclusions A web-based multidomain dementia risk reduction program augmented with allied health consultations administered within the general practice context can reduce dementia risk exposure for at least 15 months. This study was limited by a small sample size, and replication on a larger sample with longer follow-up will strengthen the results. Trial Registration Australian clinical trials registration number (ACTRN): 12616000868482; https://anzctr.org.au/ACTRN12616000868482.aspx.


Author(s):  
Ehimen Aneni ◽  
Lara Arias ◽  
Janisse Post ◽  
Shozab S Ali ◽  
Chukwuemeka U Osondu ◽  
...  

Background: Web-based platforms have been proposed as tools to facilitate lifestyle improvement, however, their efficacy in individuals with high cardiometabolic risk has not been adequately tested. The Baptist Employee Healthy Heart Study (BEHHS) was designed to assess the addition of a personalized, interactive, web-based, lifestyle-management program to the existing health-expertise web platform available to BHSF employees with metabolic syndrome (METS) or type 2 diabetes (DM2) Methods: In this 1:1 randomized, non-blinded trial, the intervention arm was provided access to a web-based personalized and interactive lifestyle program that provided targeted and personalized dietary, weight management and physical activity counseling. The intervention was in addition to access to an online wellness program, a non-interactive website that provided information on healthy diet and physical activity. The control group only had access to the online wellness program. At baseline, each participant had their demographic data collected via questionnaire. At each study visit (baseline, 4 months and 12 months) participants completed questionnaires on lifestyle indices such as diet and physical activity, had their weight, height, waist circumference, body fat (by plethysmography) and blood pressure measured. Laboratory testing was done for traditional lipids and glucose at each visit. Results: Of the 182 participants that were randomized, 163 (82 in the intervention arm and 81 in the control arm) completed the baseline survey and had complete laboratory data at baseline. Loss to follow-up was 12% at 4 months 34% at 12 months. As shown the table, intention to treat analysis using both single imputation (last observation carried forward) and multiple imputation techniques showed no difference in BMI, other measures of adiposity, blood pressure, lipids, physical activity and diet scores. When analyses were restricted to completers alone, no significant change in the results were observed. Conclusion: The addition of web-based, personalized lifestyle program to an already existing lifestyle educational platform did not significantly impact healthy lifestyle promotion and cardiometabolic risk in employees with MetS or DM2.


2020 ◽  
Vol 13 ◽  
pp. 179-185
Author(s):  
Erin Blocker ◽  
Andrew Fry ◽  
Paul Luebbers ◽  
Jeffrey Burns ◽  
Jaime Perales-Puchalt ◽  
...  

Introduction. Rural Americans (RA) have poorer vascular health and physical activity levels than their urban counterparts; all are dementia risk factors. Dementia risk reduction among rural individuals requires a tailored approach. The purpose of this project was to examine preliminary efficacy of a community-based physical exercise and/or dementia risk factor-reduction curriculum among rural adults 50 and older. Methods. Seventy-five rural dwelling adults 50 and older were randomized to one of three groups: 1) 10 weeks of Alzheimer’s disease risk-reduction education (ED), 2) risk-reduction education and supervised exercise (EDEX) or 3) control group (CON). Outcomes included baseline to 10-week follow-up difference in dementia knowledge (primary outcome) and physical activity, muscular endurance, healthy lifestyle engagement, and anthropometrics (secondary outcomes). Results. Sixty-nine adults successfully completed the 10-week study. Dementia knowledge increased in a Treatment Arm-dependent manner (χ2 = 6.95 (2), p = 0.03), being ED and EDEX superior to CON. Engagement in healthy lifestyle behaviors did not change statistically. However, participation specifically in physical activity increased over time (χ2 = 11.47 (2), p = 0.003) with EDEX reporting the greatest increases. No significant change in average daily steps was observed for any group. Conclusion. The results suggested dementia risk-reduction education, both with and without structured exercise, leads to improvements in dementia knowledge. When coupled with regular, supervised exercise, this education intervention also helped participants increase engagement in physical activity over 10 weeks. Tailored interventions that combine Alzheimer’s disease education and regular, supervised exercise may help reduce dementia risk in rural communities.


2020 ◽  
Vol 24 (63) ◽  
pp. 1-106
Author(s):  
Adrian H Taylor ◽  
Rod S Taylor ◽  
Wendy M Ingram ◽  
Nana Anokye ◽  
Sarah Dean ◽  
...  

Background There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. Objectives To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. Design A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). Setting Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. Participants There were 450 participants aged 16–74 years, with a body mass index of 30–40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. Intervention e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven ‘steps to health’. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. Primary outcome measure Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. Secondary outcomes Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. Results Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval –2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval –£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. Limitations A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. Future work The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. Conclusions Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. Trial registration Current Controlled Trials ISRCTN15644451. 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. 24, No. 63. See the NIHR Journals Library website for further project information.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e042823
Author(s):  
Oliver M Shannon ◽  
Vivian Lee ◽  
Rafe Bundy ◽  
Rachel Gillings ◽  
Amy Jennings ◽  
...  

IntroductionDementia prevalence continues to increase, and effective interventions are needed to prevent, delay or slow its progression. Higher adherence to the Mediterranean diet (MedDiet) and increased physical activity (PA) have been proposed as strategies to facilitate healthy brain ageing and reduce dementia risk. However, to date, there have been no dementia prevention trials in the UK focussed on combined dietary and PA interventions. This study aims to: (1) assess feasibility and acceptability of a theory-underpinned digital and group-based intervention for dementia risk reduction in an ‘at risk’ UK cohort; (2) evaluate behaviour change responses to the intervention; and, (3) provide information on cognitive, neurological, vascular and physiological outcomes to inform the design of a follow-on, full-scale efficacy trial.MethodsOne hundred and eight participants aged 55 to 74 years with a QRISK2 score of ≥10% will be recruited to take part in this 24-week multi-site study. Participants will be randomised into three parallel arms: (1) Control; (2) MedDiet; and, (3) MedDiet+PA. The study will evaluate a personalised website, group session and food delivery intervention to increase MedDiet adherence and PA in older adults at risk of dementia. Diet and PA will be monitored prior to, during and following the intervention. Feasibility, acceptability and hypothesised mediators will be assessed in addition to measures of cognitive function, brain structure/perfusion (MRI), vascular function and metabolic markers (blood, urine and faecal) prior to, and following, the intervention.DiscussionThis trial will provide insights into the feasibility, acceptability and mechanism of effect of a multi-domain intervention focussed on the MedDiet alone and PA for dementia risk reduction in an ‘at risk’ UK cohort.Ethics and disseminationThe study has received NHS REC and HRA approval (18/NI/0191). Findings will be disseminated via conference presentations, public lectures, and peer-reviewed publications.Trial registration detailsClinicalTrials.gov NCT03673722.


Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.


Author(s):  
Ding Ding ◽  
Minna Cheng ◽  
Borja del Pozo Cruz ◽  
Tao Lin ◽  
Shuangyuan Sun ◽  
...  

Abstract Background COVID-19 lockdowns may lead to physical inactivity, a major risk factor for non-communicable diseases. This study aims to determine: 1) the trajectory in daily step counts before, during and after the lockdown in China, and 2) the characteristics associated with the trajectories. Methods From December 2019 to July 2020, smartphone-based step counts were continuously collected in 815 Chinese adults residing in Shanghai over 202 days across three phases: before, during, and after the lockdown. Participant characteristics were reported, and height, weight and body composition measured before the lockdown. A ‘sharp’ regression discontinuity design with cluster robust standard errors was used to test the effect of the lockdown and reopening on daily steps and a linear mixed model was used to examine the characteristics associated with trajectories during the observed period. Results Based on 164,630 person-days of data, we found a sharp decline in daily step counts upon the lockdown (24/01/2020) by an average of 3796 (SE = 88) steps, followed by a significant trend of increase by 34 steps/day (SE = 2.5; p < .001) until the end of the lockdown (22/03/2020). This increasing trend continued into the reopening phase at a slower rate of 5 steps per day (SE = 2.3; p = 0.029). Those who were older, married, university educated, insufficiently active, had an ‘at risk’ body composition, and those in the control group, were slower at recovering step counts during the lockdown, and those who were older, married, without university education and with an ‘at risk’ body composition recovered step counts at a slower pace after the reopening. Conclusions Despite later increases in step counts, COVID-19 lockdown led to a sustained period of reduced physical activity, which may have adverse health implications. Governments and health professionals around the world should continue to encourage and facilitate physical activity during the pandemic.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  

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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