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Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.

ABSTRACT: BACKGROUND:Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown. We describe the theoretical basis and the rationale for a study protocol of a feasibility randomised controlled trial (RCT) comparing two attention trainings (ABMT vs Mindfulness Training [MT]) in people with overweight or obesity. The aim of this study is to inform the development of a large-scale RCT in relation to acceptability and attendance rates and to identify preliminary evidence for the interventions' clinical efficacy and potential underlying mechanisms. DESIGN:Forty-five adults who are either overweight or obese (minimum body mass index of 25?kg/m2) will be randomly allocated to receive eight sessions over eight weeks of either computerised ABMT or MT or be on a waiting list. Clinical and cognitive outcomes will be assessed at baseline, post-treatment (8?weeks) and follow-up (12?weeks post-randomisation). These include mood, body composition and attention biases. Credibility and acceptability of the trainings will be assessed using questionnaires, and recruitment and retention rates will be recorded. DISCUSSION:Findings will inform the feasibility of developing a large-scale RCT that takes into consideration effect sizes for primary outcome measures and the acceptability of the design. The study will also provide preliminary evidence on the clinical efficacy of two different attention trainings for people with obesity and associated underlying mechanisms. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018.

SUBMITTER: Mercado D

PROVIDER: S-EPMC6954613 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.

Mercado Daniela D Werthmann Jessica J Campbell Iain C IC Schmidt Ulrike U

Trials 20200110 1

<h4>Background</h4>Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e. ...[more]

PMID: 31924255

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Project description:Background:Children born preterm may display cognitive, learning, and behaviour difficulties as they grow up. In particular, very premature birth (gestation age between 28 and less than 32?weeks) may put infants at increased risk of intellectual deficits and attention deficit disorder. Evidence suggests that the basis of these problems may lie in difficulties in the development of executive functions. One of the earliest executive functions to emerge around 1?year of age is the ability to control attention. An eye-tracking-based cognitive training programme to support this emerging ability, the Attention Control Training (ACT), has been developed and tested with typically developing infants. The aim of this study is to investigate the feasibility of using the ACT with healthy very preterm (VP) infants when they are 12?months of age (corrected age). The ACT has the potential to address the need for supporting emerging cognitive abilities of VP infants with an early intervention, which may capitalise on infants' neural plasticity. Methods/design:The feasibility study is designed to investigate whether it is possible to recruit and retain VP infants and their families in a randomised trial that compares attention and social attention of trained infants against those that are exposed to a control procedure. Feasibility issues include the referral/recruitment pathway, attendance, and engagement with testing and training sessions, completion of tasks, retention in the study, acceptability of outcome measures, quality of data collected (particularly, eye-tracking data). The results of the study will inform the development of a larger randomised trial. Discussion:Several lines of evidence emphasise the need to support emerging cognitive and learning abilities of preterm infants using early interventions. However, early interventions with preterm infants, and particularly very preterm ones, face difficulties in recruiting and retaining participants. These problems are also augmented by the health vulnerability of this population. This feasibility study will provide the basis for informing the implementation of an early cognitive intervention for very preterm infants. Trial registration:Registered Registration ID: NCT03896490. Retrospectively registered at Clinical Trials Protocol Registration and Results System (clinicaltrials.gov).

Project description:Background:Huntington's disease (HD) is associated with a range of cognitive deficits including problems with executive function. In the absence of a disease modifying treatment, cognitive training has been proposed as a means of slowing cognitive decline; however, the impact of cognitive training in HD patient populations remains unclear. The CogTrainHD study assessed the feasibility and acceptability of home-based computerised executive function training, for people impacted by HD. Methods:Thirty HD gene carriers were recruited and randomised to either executive function training or non-intervention control groups. Participants allocated to the intervention group were asked to complete executive function training three times a week for 30 min for 12 weeks in their own homes. Semi-structured interviews were conducted with participants and friends, family or carers, to determine their views on the study. Results:26 out of 30 participants completed the baseline assessments and were subsequently randomised: 13 to the control group and 13 to the intervention group. 23 of the 30 participants were retained until study completion: 10/13 in the intervention group and 13/13 in the control group. 4/10 participants fully adhered to the executive function training. All participants in the control group 13/13 completed the study as intended. Interview data suggested several key facilitators including participant determination, motivation, incorporation of the intervention into routine and support from friends and family members. Practical limitations, including lack of time, difficulty and frustration in completing the intervention, were identified as barriers to study completion. Conclusions:The CogTrainHD feasibility study provides important evidence regarding the feasibility and acceptability of a home-based cognitive training intervention for people with HD. Variable adherence to the cognitive training implies that the intervention is not feasible to all participants in its current form. The study has highlighted important aspects in relation to both the study and intervention design that require consideration, and these include the design of games in the executive function training software, logistical considerations such as lack of time, the limited time participants had to complete the intervention and the number of study visits required. Further studies are necessary before computerised executive function training can be recommended routinely for people with HD. Trial registration:ClinicalTrials.gov, Registry number NCT02990676.

Project description:ImportanceWith continuing improvements in medical devices and more than a decade since the 2006 United Network for Organ Sharing (UNOS) allocation policy, it is pertinent to assess survival among patients on the heart transplantation waiting list, especially given the recently approved 2018 UNOS allocation policy.ObjectivesTo assess survival outcomes among patients on the heart transplant waiting list during the past 3 decades and to examine the association of ventricular assist devices (VADs) and the 2006 UNOS allocation policy with survival.Design, setting, and participantsA retrospective cross-sectional used the UNOS database to perform an analysis of 95 323 candidates wait-listed for heart transplantation between January 1, 1987, and December 29, 2017. Candidates for all types of combined transplants were excluded (n = 2087). Patients were followed up from the time of listing to death, transplantation, or removal from the list due to clinical improvement. Competing-risk, Kaplan-Meier, and multivariable Cox proportional hazards regression analyses were used.Main outcomes and measuresThe analysis involved an unadjusted and adjusted survival analysis in which the primary outcome was death on the waiting list. Because of changing waiting list preferences and policies during the study period, the intrinsic risk of death for wait-listed candidates was assessed by individually analyzing, comparing, and adjusting for several candidate risk factors.ResultsIn total, 95 323 candidates (72 915 men [76.5%]; mean [SD] age, 51.9 [12.0] years) were studied. In the setting of changes in listing preferences, 1-year survival on the waiting list increased from 34.1% in 1987-1990 to 67.8% in 2011-2017 (difference in proportions, 0.34%; 95% CI, 0.32%-0.36%; P < .001). The 1-year waiting list survival for candidates with VADs increased from 10.2% in 1996-2000 to 70.0% in 2011-2017 (difference in proportions, 0.60%; 95% CI, 0.58%-0.62%; P < .001). Similarly, in the setting of changing mechanical circulatory support indications, the 1-year waiting list survival for patients without VADs increased from 53.9% in 1996-2000 to 66.5% in 2011-2017 (difference in proportions, 0.13%; 95% CI, 0.12%-0.14%; P < .001). In the decade prior to the 2006 UNOS allocation policy, the 1-year waiting list survival was 51.1%, while in the decade after it was 63.9% (difference in proportions, 0.13%; 95% CI, 0.12%-0.14%; P < .001). In adjusted analysis, each time period after 1987-1990 had a marked decrease in waiting list mortality.Conclusions and relevanceThis study found temporally associated increases in heart transplant waiting list survival for all patient groups (with or without VADs, UNOS status 1 and status 2 candidates, and candidates with poor functional status).

Project description:We investigated the impact of mindfulness training (MT) on attentional performance lapses associated with task-unrelated thought (i.e., mind wandering). Periods of persistent and intensive demands may compromise attention and increase off-task thinking. Here, we investigated if MT may mitigate these deleterious effects and promote cognitive resilience in military cohorts enduring a high-demand interval of predeployment training. To better understand which aspects of MT programs are most beneficial, three military cohorts were examined. Two of the three groups were provided MT. One group received an 8-hour, 8-week variant of Mindfulness-based Mind Fitness Training (MMFT) emphasizing engagement in training exercises (training-focused MT, n = 40), a second group received a didactic-focused variant emphasizing content regarding stress and resilience (didactic-focused MT, n = 40), and the third group served as a no-training control (NTC, n = 24). Sustained Attention to Response Task (SART) performance was indexed in all military groups and a no-training civilian group (CIV, n = 45) before (T1) and after (T2) the MT course period. Attentional performance (measured by A', a sensitivity index) was lower in NTC vs. CIV at T2, suggesting that performance suffers after enduring a high-demand predeployment interval relative to a similar time period of civilian life. Yet, there were significantly fewer performance lapses in the military cohorts receiving MT relative to NTC, with training-focused MT outperforming didactic-focused MT at T2. From T1 to T2, A' degraded in NTC and didactic-focused MT but remained stable in training-focused MT and CIV. In sum, while protracted periods of high-demand military training may increase attentional performance lapses, practice-focused MT programs akin to training-focused MT may bolster attentional performance more than didactic-focused programs. As such, training-focused MT programs should be further examined in cohorts experiencing protracted high-demand intervals.

Project description:Background:Cognitive impairments, especially deficits of executive function, have been well documented as a core and early feature in Huntington's disease (HD). Cognitive impairments represent considerable burden and can be devastating for people and families affected by HD. Computerised cognitive training interventions that focus on improving executive function present a possible non-pharmacological treatment option. We propose to determine the feasibility, acceptability, and appropriate outcome measures for use in a randomised controlled feasibility study. Methods/design:Participants will be randomised into either a computerised cognitive training group or a control group. Those randomised to the training group will be asked to complete a cognitive training intervention based on the HappyNeuron Pro software tasks of executive function, for a minimum of 30 min, three times a week for the 12-week study duration. Participants in the control group will not receive computerised cognitive training but will receive a similar degree of social interaction via equivalent study and home visits. We will explore quantitative outcome measures, including measures of cognitive performance, motor function, questionnaires and semi-structured interviews, as well as magnetic resonance imaging (MRI) measures in a subset of participants. Feasibility will be determined through assessment of recruitment, retention, adherence and acceptability of the intervention. Discussion:The results of this study will provide crucial guidance and information regarding the feasibility of conducting a randomised controlled study into computerised cognitive training in HD. This study is crucial for the development of larger definitive randomised controlled trials which are powered to determine efficacy and for the development of future cognitive training programmes for people affected by HD. Trial registration:The study is registered on clinicaltrials.gov and has the unique identifier NCT02990676.

Dataset Information

Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.

Publications

Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.

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