Dataset Information

Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.

ABSTRACT:

Background

Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy.

Methods

A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45-75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded.

SUBMITTER: Suls J

PROVIDER: S-EPMC10276207 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.

Suls Jerry J Friel Ciarán P CP Butler Mark M Duer-Hefele Joan J Robles Patrick L PL Vicari Frank F Chandereng Thevaa T Cheung Ying Kuen Ken YKK Davidson Karina W KW

Contemporary clinical trials communications 20230605

<h4>Background</h4>Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the h ...[more]

PMID: 37333978

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Project description:BackgroundInterventions aimed at promoting physical activity (PA) behavior through habit formation pathways are gaining popularity, as they differ from conventional interventions that rely on intention pathways. Past research has established a positive correlation between PA habits and behavior. However, the efficacy of current interventions designed to form PA habits and improve PA automaticity is not yet fully ascertained. Additionally, the intervention components that significantly impact the effectiveness of these interventions are yet to be determined.MethodsThis systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We conducted a search of three databases (PubMed, Embase, and Cochrane Library) from January 2000 to December 2022, with a focus on interventions for developing PA habits. Two independent authors conducted paper selection, quality assessment, data extraction, and coding of behavior change techniques (BCTs). The effect size of interventions was calculated using standardized mean difference. Subgroup analyses were carried out based on follow-up duration, delivery method, sample characteristics, and theory. Furthermore, we employed meta-regression to investigate the association between BCTs and PA habits.ResultsTen eligible studies with relatively high quality were included in the final data set. Characteristics of studies varied in intervention sample and delivery way. The habit formation interventions significantly increased PA habit (SMD = 0.31, 95% CI 0.14-0.48, P < .001) compared to the control groups. Subgroup analysis demonstrated that the duration of follow-up ≤ 12 weeks have a higher effect size on PA habit than the duration > 12 weeks. Meta-regression revealed that problem solving has a significant positive association with effectiveness improvement (β = 0.36, 95% CI 0.17-0.55), while social reward is linked with a reduction in effectiveness (β = -0.40, 95% CI -0.74-0.06).ConclusionsOur findings reveal that habit formation interventions are effective in fostering PA habit. Future studies could leverage the insights form this study to optimize the intervention design and achieve better effectiveness.

Project description:Despite the extensive evidence on the benefits of physical activity (PA) in older adults, including reduced risk of disease, mortality, falls, and cognitive and functional decline, most do not attain sufficient PA levels. Theoretical work suggests that behavioral change interventions are most effective during life transitions, and as such, a theory-based, online intervention tailored for recently retired and empty nest individuals could lend support for increasing levels of PA. The aim of this study is to examine the feasibility of the intervention and study procedures for a future controlled trial. This study has a randomized controlled trial design with an embedded qualitative and quantitative process evaluation. Participants are randomized at 1:1 between the intervention and waitlist controls. Potential participants are within six months of their final child leaving the familial home or within six months of retiring (self-defined), currently not meeting the Canadian PA guidelines, have no serious contraindications to exercise, and are residing in Victoria, British Columbia, Canada. Participants are recruited by online and print flyers as well as in-person at community events. The study aims to recruit 40 empty nest and 40 retired participants; half of each group received the intervention during the study period. The internet-delivered intervention is delivered over a 10-week period, comprising 10 modules addressing behavior change techniques associated with PA. Primary outcomes relate to recruitment, attrition, data collection, intervention delivery, and acceptability. Secondary behavioral outcomes are measured at baseline and post-treatment (10 weeks). Intervention-selected participants are invited to an optional qualitative exit interview. The results of this feasibility study will inform the planning of a randomized effectiveness trial, that will examine the behavior change, health-related fitness, and well-being outcomes by exploring how reflexive processes of habit and identity may bridge adoption and maintenance in behavioral adherence.

Project description:Background: Older adults living in long term care, rehabilitation hospitals, and seniors' residences often experience reduced mobility, sometimes resulting in confinement indoors and isolation, which can introduce or aggravate symptoms of depression, anxiety, loneliness, and apathy. As Virtual Reality (VR) technologies become increasingly accessible and affordable, there is a unique opportunity to enable older adults to escape their restricted physical realities and be transported to both stimulating and calming places which may improve their general well-being. To date no robust evaluations of the use of immersive VR therapy [experienced through a head-mounted-display (HMD)] for older adults within these settings have been reported. VR-therapy may prove to be a safe, inexpensive, non-pharmacological means of managing depressive symptoms and providing engagement and enjoyment to this rapidly growing demographic. Objectives: Establish whether it is feasible to use immersive VR technology as therapy for older adults who have reduced sensory, mobility and/or impaired cognition. This includes evaluation of tolerability, comfort, and ease of use of the HMD, and of the potential for immersive VR to provide enjoyment/relaxation and reduce anxiety and depressive symptoms. Methods: Sixty-six older adults (mean age 80.5, SD = 10.5) with varying cognitive abilities (normal = 28, mild impairment = 17, moderate impairment = 12, severe impairment = 3, unknown cognitive score = 6), and/or physical impairments, entered a multi-site non-randomized interventional study in Toronto, Canada. Participants experienced 3 to 20 min of 360°-video footage of nature scenes displayed on Samsung GearVR HMD. Data was collected through pre/post-intervention surveys, standardized observations during intervention, and post-intervention semi-structured interviews addressing the VR experience. Results: All participants completed the study with no negative side-effects reported (e.g., No dizziness, disorientation, interference with hearing aids); the average time spent in VR was 8 min and 76% of participants viewed the entire experience at least once. Participants tolerated the HMD very well; most had positive feedback, feeling more relaxed and adventurous; 76% wanted to try VR again. Better image quality and increased narrative video content were suggested to improve the experience. Conclusion: It is feasible and safe to expose older adults with various levels of cognitive and physical impairments to immersive VR within these settings. Further research should evaluate the potential benefits of VR in different settings (e.g., home/community based) and explore better customization/optimization of the VR content and equipment for the targeted populations.

Project description:ObjectiveThe purpose of this study was to assess whether the superior cost-effectiveness of a personalized physical therapy approach (Coach2Move)-which was demonstrated in a previous trial compared with usual care physical therapy (UCP)-can be replicated in daily clinical practice.MethodsA multicenter, cluster-randomized, stepped wedge trial with 4 clusters consisting of 4 physical therapist practices in the Netherlands was used to compare a personalized physical therapy approach to elicit physical activity (Coach2Move) versus care as usual. Multilevel analyses for effectiveness were conducted for the amount of physical activity (Longitudinal Aging Study Amsterdam Physical Activity Questionnaire) and functional mobility (Timed "Up & Go" Test) at 3, 6 (primary outcome), and 12 months' follow-up. Secondary outcomes were level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient-Specific Complaints Questionnaires), quality of life (Euro Quality of Life-5 Dimensions-5 Levels [EQ-5D-5L]), and health care expenditures.ResultsThe 292 community-dwelling older adults with mobility problems visiting physical therapists were included in either the Coach2Move (n = 112; mean [SD] age = 82 [5] years; 60% female) or UCP (n = 180; mean [SD] age = 81 (6) years; 62% female) section of the trial. At baseline, Coach2Move participants were less physically active compared with UCP participants (mean difference = -198; 95% CI = -90 to -306 active minutes). At 6 months, between-group mean differences [95% CI] favored Coach2Move participants on physical activity levels (297 [83 to 512] active minutes), functional mobility (-14.2 [-21 to -8]) seconds), and frailty levels (-5 [-8 to -1] points). At 12 months, the physical activity levels of Coach2Move participants further increased, and frailty levels and secondary outcomes remained stable, whereas outcomes of UCP participants decreased. After the Coach2Move implementation strategy, physical therapists utilized significantly fewer treatment sessions compared with before the implementation (15 vs 22). Anticipated cost savings were not observed.ConclusionThis study replicated the results of an earlier trial and shows that Coach2Move leads to better mid- and long-term outcomes (physical activity, functional mobility, level of frailty) in fewer therapy sessions compared with UCP. Based on these and earlier findings, the implementation of Coach2Move in physical therapist practice is recommended.ImpactThis article describes the implementation of the Coach2Move approach, a treatment strategy that has proven to be cost-effective in a previously conducted randomized controlled trial. Implementation of Coach2Move in a real-life setting allowed an evaluation of the effects in a clinically relevant population. Coach2Move has been shown to increase physical activity, improve functional mobility, and reduce frailty more effectively compared with UCP therapy and therefore has application for physical therapists working with older adults in daily clinical practice.Lay summaryCoach2Move is a new physical therapy approach for older adults. Implementation of Coach2Move in daily clinical practice can help people better outcomes over a longer period of time against similar costs compared with regular physical therapy.

Dataset Information

Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.

Background

Methods

Publications

Protocol of a feasibility study of a virtual personalized (N-of-1) trial for increasing low-intensity physical activity in older adults via habit formation.

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