scholarly journals Effect of MIND Diet Intervention on Cognitive Performance and Brain Structure in Healthy Obese Women: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Golnaz Arjmand ◽  
Mojtaba Abbas-Zadeh ◽  
Mohammad Hassan Eftekhari
Keyword(s):  
Cognitive Performance ◽  
Brain Structure ◽  
Controlled Trial ◽  
Diet Group ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled ◽  
Healthy Obese ◽  
The Mind ◽  
Mind Diet

AbstractBackground and AimPrevious studies suggested adherence to recently developed Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) associated with cognitive performance. There was no prior Randomized controlled Trial (RCT) to investigate this association. This study aimed to examine the effect of MIND dietary pattern on features of cognitive performance and also changes in brain structure in healthy obese women.MethodsAs a total of 50 obese women assessed for eligibility, we randomly allocated 40 participants with mean BMI 32 ± 4.31 and mean age 48 ± 5.38 years to either calorie-restricted modified MIND diet or a calorie-restricted standard control diet. Change in cognitive performance was the primary outcome measured with a comprehensive neuropsychological test battery. We also performed voxel-based morphometry as a secondary outcome to quantify the differences in brain structure. All of the measurements administered at baseline and three months follow up.ResultsThirty-seven participants (MIND group=22 and control group=15) completed the study. The results found in the MIND diet group working memory +1.37 (95% CI: 0.79,1.95), verbal recognition memory +4.85 (95% CI: 3.30,6.40), and attention +3.75 (95% CI: 2.43,5.07) improved more compared with the control group (ps < 0.05). Results of brain MRI consists of an increase in surface area of inferior frontal gyrus in the MIND diet group. Furthermore, the results showed a decrease in the cerebellum-white matter and cerebellum-cortex in two groups of study. Still, the effect in the MIND group was greater than the control group.ConclusionsThe study findings declare for the first time that the MIND diet intervention can reverse the destructive effects of obesity on cognition and brain structure, which could be strengthened by a modest calorie restriction.

scholarly journals Randomized Controlled Trial Effect of Short-Term MIND Diet Intervention on Hunger Hormones, Anthropometric Parameters, and Brain Structures in Middle-Aged Obese Women

2020 ◽  
Author(s):  
Golnaz Arjmand ◽  
Mojtaba Abbas-Zadeh ◽  
Majid fardaei ◽  
Mohammad Hassan Eftekhari
Keyword(s):  
Controlled Trial ◽  
Brain Structures ◽  
Diet Group ◽  
Control Group ◽  
Obese Women ◽  
Short Term ◽  
Anthropometric Parameters ◽  
The Mind ◽  
Mind Diet

AbstractThe growing prevalence of obesity and its destructive effects on the hormone’s circulation and brain structures has attracted attention to specific dietary patterns. This trial aimed to examine the effect of short-term newly Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) pattern on anthropometric parameters, hunger hormones as well as brain structures in obese women. The study was a randomized restricted controlled trial in which we analyzed 37 healthy obese women with a mean age of 48 ± 5.38 years and mean Body Mass Index (BMI) 32 ± 4.31 kg/m2. Participants were randomly allocated to a hypocaloric modified MIND diet or a hypocaloric waiting list control diet and followed the protocols for three months. Differences in anthropometric and laboratory analysis, as well as brain structures, were determined at baseline and follow up. There was a more significant reduction in weight, BMI, percentage of body fat, waist circumference, and Leptin concentration in the MIND diet group compared to the control group (ps<0.05). Despite a deceased in plasma levels of Ghrelin and GLP-1 in the control group, results have found a significant increase in these hunger hormones in the MIND diet group (ps<0.05). Our results diminished to detect any differences in the whole and regional brain structures between two groups after three months follow up. Our trial for the first time demonstrated that a three-month MIND diet intervention could improve the potentially devastating effect of obesity on metabolic profiles and anthropometric parameters. However, we couldn’t find the MIND diet effect on brain structures.

scholarly journals Imaginal retraining decreases craving for high-calorie food in overweight and obese women: A randomized controlled trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Steffen Moritz ◽  
Anja S. Göritz ◽  
Stella Schmotz ◽  
Roland Weierstall-Pust ◽  
Josefine Gehlenborg ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Medium Effect ◽  
Favorable Effect ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled ◽  
High Calorie

AbstractOverweight and obesity are epidemic conditions. Obesity is associated with somatic and psychological sequelae, including serious life-shortening disorders (e.g., diabetes). This study aimed to evaluate the efficacy of a newly developed imaginal variant of approach bias modification (i.e., imaginal retraining) for the reduction of craving for high-calorie food. In a randomized controlled trial, 384 women with a body mass index above 25 were allocated to a wait-list control group or to two variants of imaginal retraining (ratio: 1; 0.5; 0.5). The two intervention groups were sent a manual on imaginal retraining. One group was explicitly encouraged and instructed to use electronic reminders (RER); the standard retraining group (RS) was not encouraged to use electronic reminders. Assessments were 6 weeks apart and were carried out online. Craving for high-calorie food represented the primary outcome (based on the Visual Analog Scale, VAS). Secondary outcomes included the Food Cravings Questionnaire (FCQ-T-R). The study was registered as DRKS00017220. Women in the RER group utilized the retraining technique more often than those in the RS condition, and utilization frequency in turn was associated with improvement on craving and eating behavior scales. Both intention-to-treat and per-protocol analyses showed a favorable effect of the RER group, which achieved significance on the primary outcome, as well as on several other outcomes relative to controls at a small to medium effect size. For those participants who measured their weight before and after the assessment using a scale, weight loss in the RER group was significantly greater compared to the control group. Both retraining groups (RER: 39.4%; RS: 31.1%) reduced their subjective amount of eating relative to controls (24.2%). Approximately two-thirds of the sample (68.3%) performed the exercises at least once during the study period. The present results show that, when used regularly, imaginal retraining may reduce craving for high-calorie food in overweight and obese women. Of note, there was also evidence suggestive of weight reduction, although no diet or lifestyle change was recommended in the manual. Because a large subgroup neither read the manual nor performed the exercises, we recommend that future imaginal retraining be conveyed via short video clips.

scholarly journals Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Composition ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Body ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled

BACKGROUND Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. OBJECTIVE A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). METHODS A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. RESULTS Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; <i>P</i>&lt;.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; <i>P</i>&lt;.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; <i>P</i>&gt;.05). CONCLUSIONS Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. CLINICALTRIAL ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

scholarly journals A pilot randomized controlled trial of exercise to improve cognitive performance in patients with stable glioma: a proof of concept

2019 ◽  
Vol 22 (1) ◽  
pp. 103-115 ◽  
Author(s):  
Karin Gehring ◽  
Martijn M Stuiver ◽  
Eva Visser ◽  
Corelien Kloek ◽  
Martin van den Bent ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Performance ◽  
Cognitive Deficits ◽  
Controlled Trial ◽  
Exercise Group ◽  
Control Group ◽  
Proof Of Concept ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs). Methods Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20–45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months. Results The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health–related quality of life. Conclusions This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.

scholarly journals Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial

10.2196/13747 ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. e13747 ◽  
Author(s):  
Alberto Hernández-Reyes ◽  
Fernando Cámara-Martos ◽  
Guillermo Molina Recio ◽  
Rafael Molina-Luque ◽  
Manuel Romero-Saldaña ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trial ◽  
Weight Loss ◽  
Body Composition ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Body ◽  
Control Group ◽  
Obese Women ◽  
Randomized Controlled

Background Technology—in particular, access to the Internet from a mobile device—has forever changed the way we relate to others and how we behave in our daily life settings. In recent years, studies have been carried out to analyze the effectiveness of different actions via mobile phone in the field of health: telephone calls, short message service (SMS), telemedicine, and, more recently, the use of push notifications. We have continued to explore ways to increase user interaction with mobile apps, one of the pending subjects in the area of mHealth. By analyzing the data produced by subjects during a clinical trial, we were able to extract behavior patterns and, according to them, design effective protocols in weight loss programs. Objective A clinical trial was proposed to (1) evaluate the efficacy of push notifications in an intervention aimed at improving the body composition of adult women who are overweight or obese, through a dietary procedure, and (2) analyze the evolution of body composition based on push notifications and prescribed physical activity (PA). Methods A two-arm randomized controlled trial was carried out. A sample size of 117 adult obese women attended a face-to-face, 30-minute consultation once a week for 6 months. All patients were supplied with an app designed for this study and a pedometer. The control group did not have access to functionalities related to the self-monitoring of weight at home, gamification, or prescription of PA. The intervention group members were assigned objectives to achieve a degree of compliance with diet and PA through exclusive access to specific functionalities of the app and push notifications. The same diet was prescribed for all patients. Three possible PA scenarios were studied for both the control and intervention groups: light physical activity (LPA), moderate physical activity (MPA), and intense physical activity (IPA). For the analysis of three or more means, the analysis of variance (ANOVA) of repeated means was performed to evaluate the effects of the intervention at baseline and at 3 and 6 months. Results Receiving notifications during the intervention increased body fat loss (mean -12.9% [SD 6.7] in the intervention group vs mean -7.0% [SD 5.7] in the control group; P<.001) and helped to maintain muscle mass (mean -0.8% [SD 4.5] in the intervention group vs mean -3.2% [SD 2.8] in the control group; P<.018). These variations between groups led to a nonsignificant difference in weight loss (mean -7.9 kg [SD 3.9] in the intervention group vs mean -7.1 kg [SD 3.4] in the control group; P>.05). Conclusions Push notifications have proven effective in the proposed weight loss program, leading women who received them to achieve greater loss of fat mass and a maintenance or increase of muscle mass, specifically among those who followed a program of IPA. Future interventions should include a longer evaluation period; the impact of different message contents, as well as message delivery times and frequency, should also be researched. Trial Registration ClinicalTrials.gov NCT03911583; https://www.clinicaltrials.gov/ct2/show/NCT03911583

Transferability and Sustainability of Motor-Cognitive Dual-Task Training in Patients with Dementia: A Randomized Controlled Trial

Gerontology ◽  
2018 ◽  
Vol 65 (1) ◽  
pp. 68-83 ◽  
Author(s):  
Nele Christin Lemke ◽  
Christian Werner ◽  
Stefanie Wiloth ◽  
Peter Oster ◽  
Jürgen M. Bauer ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Performance ◽  
Dual Task ◽  
Verbal Fluency ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Transfer Effects ◽  
Significant Group ◽  
Randomized Controlled

Background: Specific dual-task (DT) training is effective to improve DT performance in trained tasks in patients with dementia (PwD). However, it remains an open research question whether successfully trained DTs show a transfer effect to untrained DT performances. Objective: To examine transfer effects and the sustainability of a specific DT training in PwD. Methods: One hundred and five patients with mild-to-moderate dementia (Mini-Mental State Examination: 21.9 ± 2.8 points) participated in a 10-week randomized, controlled trial. The intervention group (IG) underwent a specific DT training (“walking and counting”). The control group (CG) performed unspecific low-intensity exercise. DT performance was measured under three conditions: (1) “walking and counting” (trained); (2) “walking and verbal fluency” (semi-trained), and (3) “strength and verbal fluency” (untrained). Outcomes evaluated at baseline, after training, and 3 months after the intervention period included absolute values for the motor and cognitive performance under DT conditions, and relative DT costs (DTCs) in motor, cognitive and combined motor-cognitive performance. Results: The IG significantly improved DT performances in the trained condition for absolute motor and cognitive performance and for motor, cognitive, and combined motor-cognitive DTCs compared to the CG (p ≤ 0.001–0.047; ηp2 = 0.044–0.249). Significant transfer effects were found in the semi-trained condition for absolute motor and partly cognitive performance, and for motor but not for cognitive DTCs, and only partly for combined DTCs (p ≤ 0.001–0.041; ηp2 = 0.049–0.150). No significant transfer effects were found in the untrained condition. Three months after training cessation, DT performance in the trained condition was still elevated for most of the outcomes (p ≤ 0.001–0.038; ηp2 = 0.058–0.187). Training gains in the DT performance in the semi-trained condition were, however, not sustained, and no significant group differences were found in the DT performance in the untrained condition after the follow-up. Conclusion: This study confirmed that specific DT training is effective in improving specifically trained DT performances in PwD and demonstrated sustainability of training-induced effects for at least 3 months. Effects were partially transferable to semi-trained DTs but not to untrained DTs. With increasing distance between trained and untrained DTs, transferability of training effects decreased.

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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