scholarly journals Demin: Design and baseline results of a cluster randomized controlled trial investigating the uptake and effectiveness of a dementia risk reduction program in middle‐aged descendants of people with recently diagnosed Alzheimer disease or vascular dementia

2020 ◽  
Vol 16 (S10) ◽  
Author(s):  
Joyce Vrijsen ◽  
Els Maeckelberghe ◽  
Ameen Abu‐Hanna ◽  
Peter Paul De Deyn ◽  
Andrea de Winter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Alzheimer Disease ◽  
Vascular Dementia ◽  
Risk Reduction ◽  
Controlled Trial ◽  
Middle Aged ◽  
Randomized Controlled ◽  
Dementia Risk ◽  
Reduction Program ◽  
Cluster Randomized

scholarly journals A Social Group-Based Information-Motivation-Behavior Skill Intervention to Promote Acceptability and Adoption of Wearable Activity Trackers Among Middle-Aged and Older Adults: Cluster Randomized Controlled Trial

10.2196/14969 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e14969
Author(s):  
Jing Liao ◽  
Hai-Yan Xiao ◽  
Xue-Qi Li ◽  
Shu-Hua Sun ◽  
Shi-Xing Liu ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Social Group ◽  
Controlled Trial ◽  
Daily Step ◽  
Middle Aged ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Wearable Activity Trackers ◽  
Cluster Randomized

Background Wearable activity trackers offer potential to optimize behavior and support self-management. To assist older adults in benefiting from mobile technologies, theory-driven deployment strategies are needed to overcome personal, technological, and sociocontextual barriers in technology adoption. Objective To test the effectiveness of a social group–based strategy to improve the acceptability and adoption of activity trackers by middle-aged and older adults. Methods A cluster randomized controlled trial was conducted among 13 groups of middle-aged and older adults (≥45 years) performing group dancing (ie, square dancing) as a form of exercise in Guangzhou from November 2017 to October 2018. These dancing groups were randomized 1:1 into two arms, and both received wrist-worn activity trackers and instructions at the baseline face-to-face assessment. Based on the Information-Motivation-Behavior Skill framework, the intervention arm was also given a tutorial on the purpose of exercise monitoring (Information), encouraged to participate in exercise and share their exercise records with their dancing peers (Motivation), and were further assisted with the use of the activity tracker (Behavior Skill). We examined two process outcomes: acceptability evaluated by a 14-item questionnaire, and adoption assessed by the uploaded step count data. Intention-to-treat analysis was applied, with the treatment effects estimated by multilevel models. Results All dancing groups were followed up for the postintervention reassessment, with 61/69 (88%) participants of the intervention arm (7 groups) and 56/80 (70%) participants of the control arm (6 groups). Participants’ sociodemographic characteristics (mean age 62 years, retired) and health status were comparable between the two arms, except the intervention arm had fewer female participants and lower cognitive test scores. Our intervention significantly increased the participants’ overall acceptability by 6.8 points (95% CI 2.2-11.4), mainly driven by promoted motivation (adjusted group difference 2.0, 95% CI 0.5-3.6), increased usefulness (adjusted group difference 2.5, 95% CI 0.9-4.1), and better perceived ease of use (adjusted group difference 1.2, 95% CI 0.1-2.4), whereas enjoyment and comfort were not increased (adjusted group difference 0.9, 95% CI –0.4-2.3). Higher adoption was also observed among participants in the intervention arm, who were twice as likely to have valid daily step account data than their controlled counterparts (adjusted incidence relative risk [IRR]=2.0, 95% CI 1.2-3.3). The average daily step counts (7803 vs 5653 steps/day for the intervention and control, respectively) were similar between the two arms (adjusted IRR=1.4, 95% CI 0.7-2.5). Conclusions Our social group–based deployment strategy incorporating information, motivation, and behavior skill components effectively promoted acceptability and adoption of activity trackers among community-dwelling middle-aged and older adults. Future studies are needed to examine the long-term effectiveness and apply this social engagement strategy in other group settings or meeting places. Trial Registration Chinese Clinical Trial Registry ChiCTR-IOC-17013185; https://tinyurl.com/vedwc7h.

scholarly journals Effectiveness of a Yoga-Based Lifestyle Protocol (YLP) in Preventing Diabetes in a High-Risk Indian Cohort: A Multicenter Cluster-Randomized Controlled Trial (NMB-Trial)

2021 ◽  
Vol 12 ◽  
Author(s):  
Nagarathna Raghuram ◽  
Venkat Ram ◽  
Vijaya Majumdar ◽  
Rajesh SK ◽  
Amit Singh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Sample Size ◽  
Risk Reduction ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Trial Registration ◽  
Randomized Controlled ◽  
Cluster Randomized

IntroductionThough several lines of evidence support the utility of yoga-based interventions in diabetes prevention, most of these studies have been limited by methodological issues, primarily sample size inadequacy. Hence, we tested the effectiveness of yoga-based lifestyle intervention against diabetes risk reduction in multicentre, large community settings of India, through a single-blind cluster-randomized controlled trial, Niyantrita Madhumeha Bharat Abhiyan (NMB). Research Design and MethodsNMB-trial is a multicentre cluster-randomized trial conducted in 80 clusters [composed of rural units (villages) and urban units (Census Enumeration Blocks)] randomly assigned in a 1:1 ratio to intervention and control groups. Participants were individuals (age, 20–70 years) with prediabetes (blood HbA1c values in the range of 5.7–6.4%) and IDRS ≥ 60. The intervention included the practice of yoga-based lifestyle modification protocol (YLP) for 9 consecutive days, followed by daily home and weekly supervised practices for 3 months. The control cluster received standard of care advice for diabetes prevention. Statistical analyses were performed on an intention-to-treat basis, using available and imputed datasets. The primary outcome was the conversion from prediabetes to diabetes after the YLP intervention of 3 months (diagnosed based upon HbA1c cutoff >6.5%). Secondary outcome included regression to normoglycemia with HbA1c <5.7%.ResultsA total of 3380 (75.96%) participants were followed up at 3 months. At 3 months post-intervention, overall, diabetes developed in 726 (21.44%) participants. YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55–69.85). The YLP also accelerated regression to normoglycemia [adjusted Odds Ratio (adjOR) = 1.20 (95% CI, 1.02–1.43)]. Importantly, younger participants (≤40 years) were found to regress to normoglycemia more effectively than the older participants Pinteraction<0.001. ConclusionBased on the significant risk reduction derived from the large sample size, and the carefully designed randomized yoga-based intervention on high-risk populations, the study is a preliminary but strong proof-of-concept for yoga as a potential lifestyle-based treatment to curb the epidemic of diabetes. The observed findings also indicate a potential of YLP for diabetes prevention in low/moderate risk profile individuals that needs large-scale validation.Trial RegistrationClinical Trial Registration Number: CTRI/2018/03/012804.

scholarly journals A Social Group-Based Information-Motivation-Behavior Skill Intervention to Promote Acceptability and Adoption of Wearable Activity Trackers Among Middle-Aged and Older Adults: Cluster Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Jing Liao ◽  
Hai-Yan Xiao ◽  
Xue-Qi Li ◽  
Shu-Hua Sun ◽  
Shi-Xing Liu ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Social Group ◽  
Controlled Trial ◽  
Daily Step ◽  
Middle Aged ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Wearable Activity Trackers ◽  
Cluster Randomized

BACKGROUND Wearable activity trackers offer potential to optimize behavior and support self-management. To assist older adults in benefiting from mobile technologies, theory-driven deployment strategies are needed to overcome personal, technological, and sociocontextual barriers in technology adoption. OBJECTIVE To test the effectiveness of a social group–based strategy to improve the acceptability and adoption of activity trackers by middle-aged and older adults. METHODS A cluster randomized controlled trial was conducted among 13 groups of middle-aged and older adults (≥45 years) performing group dancing (ie, square dancing) as a form of exercise in Guangzhou from November 2017 to October 2018. These dancing groups were randomized 1:1 into two arms, and both received wrist-worn activity trackers and instructions at the baseline face-to-face assessment. Based on the Information-Motivation-Behavior Skill framework, the intervention arm was also given a tutorial on the purpose of exercise monitoring (Information), encouraged to participate in exercise and share their exercise records with their dancing peers (Motivation), and were further assisted with the use of the activity tracker (Behavior Skill). We examined two process outcomes: acceptability evaluated by a 14-item questionnaire, and adoption assessed by the uploaded step count data. Intention-to-treat analysis was applied, with the treatment effects estimated by multilevel models. RESULTS All dancing groups were followed up for the postintervention reassessment, with 61/69 (88%) participants of the intervention arm (7 groups) and 56/80 (70%) participants of the control arm (6 groups). Participants’ sociodemographic characteristics (mean age 62 years, retired) and health status were comparable between the two arms, except the intervention arm had fewer female participants and lower cognitive test scores. Our intervention significantly increased the participants’ overall acceptability by 6.8 points (95% CI 2.2-11.4), mainly driven by promoted motivation (adjusted group difference 2.0, 95% CI 0.5-3.6), increased usefulness (adjusted group difference 2.5, 95% CI 0.9-4.1), and better perceived ease of use (adjusted group difference 1.2, 95% CI 0.1-2.4), whereas enjoyment and comfort were not increased (adjusted group difference 0.9, 95% CI –0.4-2.3). Higher adoption was also observed among participants in the intervention arm, who were twice as likely to have valid daily step account data than their controlled counterparts (adjusted incidence relative risk [IRR]=2.0, 95% CI 1.2-3.3). The average daily step counts (7803 vs 5653 steps/day for the intervention and control, respectively) were similar between the two arms (adjusted IRR=1.4, 95% CI 0.7-2.5). CONCLUSIONS Our social group–based deployment strategy incorporating information, motivation, and behavior skill components effectively promoted acceptability and adoption of activity trackers among community-dwelling middle-aged and older adults. Future studies are needed to examine the long-term effectiveness and apply this social engagement strategy in other group settings or meeting places. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR-IOC-17013185; https://tinyurl.com/vedwc7h.

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