Nutritional Intervention to Prevent Weight Gain in Patients Commenced on Olanzapine: A Randomizedcontrolled Trial

2005 ◽  
Vol 39 (6) ◽  
pp. 479-486 ◽  
Author(s):  
Sherryn Evans ◽  
Richard Newton ◽  
Sally Higgins

Objective: Olanzapine is the most commonly prescribed atypical antipsychotic medication in Australia. Research repor ts an average weight gain of between 4.5 and 7 kg in the 3 months following its commencement. Trying to minimize this weight gain in a population with an already high prevalence of obesity, mor tality and morbidity is of clinical and social importance. This randomized controlled trial investigated the impact of individual nutrition education provided by a dietitian on weight gain in the 3 and 6 months following the commencement of olanzapine. Method: Fifty-one individuals (29 females, 22 males) who had star ted on olanzapine in the previous 3 months (mean length of 27 days 20) were recruited through Peninsula Health Psychiatric Services and were randomly assigned to either the intervention (n = 29) or the control group (n = 22). Individuals in the intervention group received six 1 hour nutrition education sessions over a 3-month period. Weight, waist circumference, body mass index (BMI) and qualitative measures of exercise levels, quality of life, health and body image were collected at baselineat 3 and 6 months. Results: After 3 months, the control group had gained significantly more weight than the treatment group (6.0 kg vs 2.0 kg, p≤0.002). Weight gain of more than 7% of initial weight occurred in 64% of the control group compared to 13% of the treatment group. The control group's BMI increased significantly more than the treatment group's (2 kg/m2 vs 0.7 kg/m2, p ≤0.03). The treatment group reported significantly greater improvements in moderate exercise levels, quality of life, health and body image compared to the controls. At 6 months, the control group continued to show significantly more weight gain since baseline than the treatment group (9.9 kg vs 2.0 kg, p≤0.013) and consequently had significantly greater increases in BMI (3.2 kg/m2vs 0.8 kg/m2, p ≤0.017). Conclusion: Individualnutritional intervention provided bya dietitian is highly successful at preventing olanzapine-induced weight gain.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xin Ye ◽  
Dawei Zhu ◽  
Siyuan Chen ◽  
Xuefeng Shi ◽  
Rui Gong ◽  
...  

Abstract Background Hearing loss is quite prevalent and can be related to people’s quality of life. To our knowledge, there are limited studies assessing the efficacy of hearing interventions on quality of life in adults. Therefore, we aim to conduct a randomized controlled trial (RCT) to determine the impact and cost-effectiveness of community-based hearing rehabilitation on quality of life among Chinese adults with hearing loss. Methods/design In this two-arm feasibility study, participants aged 16 and above with some degree of hearing loss (n = 464) will be recruited from Linyi City, Shandong Province. They are randomly assigned to the treatment group or the control group. Those in the treatment group are prescribed with hearing aids, while those in the control group receive no intervention. Reinstruction in use of devices is provided for the treatment group during booster visits held 12 months post-randomization or unscheduled interim visits when necessary. Data are collected at baseline and the follow-up 20 months later. The primary outcome is changes in quality of life over a 20-month study period. Secondary outcomes include sub-dimensions in quality of life, physical functioning, chronic diseases, cognitive function, depression, social support, hospitalizations, falls, and healthcare costs. Finally, we will evaluate whether hearing aids intervention is cost-effective to apply in a large scale. Discussion The trial is designed to evaluate the impact and cost-effectiveness of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss. We hope that it would help improve the well-being for Chinese adults and provide references in policy and practice for China and other countries. Trial registration Chinese Clinical Trial Registry ChiCTR1900024739. Registered on 26 July 2019.


Author(s):  
Francisco Javier Amarilla-Donoso ◽  
Raúl Roncero-Martín ◽  
Jesus Lavado-García ◽  
María de la Luz Canal-Macías ◽  
María Pedrera-Canal ◽  
...  

The objective of this study was to determine the impact of a postoperative educational intervention program on the health-related quality of life (HRQoL) of patients with hip fracture using a controlled clinical trial in a randomized, multicenter study. In total, 102 patients (45.5%) from trauma units at the two University Hospitals of the province of Cáceres received the educational program, whereas 122 (54.5%) did not. Patients were consecutively included in either an intervention or a control group. Patients from the intervention group received an educational program during admission and the postoperative period. Patients from the control group did not receive any educational program. These patients were managed according to routine protocols. The patients were predominantly female (76.3%), aged 84.6 years (SD 6.1). All dimensions in both groups at 12 months showed a significant decrease with respect to baseline, except for bodily pain in both groups (p = 0.447; p = 0.827) and social functioning in the intervention group (p = 0.268). Patients receiving the educational program showed higher levels in the dimensions of the Mental Component Summary (MCS-12) (p = 0.043), vitality (p = 0.010), and social functioning (p < 0.001), as well as in the dimensions of the SF-12 health survey questionnaire of HRQoL 12 months after surgery. In conclusion, our study of the intervention group showed that there were significant improvements in MCS-12, vitality, and social function dimensions compared to the control group.


2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability. Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men ( P <0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus ( P =0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration : ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513


BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e040316
Author(s):  
Jose-M Ramirez-Rodriguez ◽  
Javier Martinez-Ubieto ◽  
Jose-L Muñoz-Rodes ◽  
Jose-R Rodriguez-Fraile ◽  
Jose-A Garcia-Erce ◽  
...  

IntroductionThe evidence currently available from enhanced recovery after surgery (ERAS) programmes concerns their benefits in the immediate postoperative period, but there is still very little evidence as to whether their correct implementation benefits patients in the long term. The working hypothesis here is that, due to the lower response to surgical aggression and lower rates of postoperative complications, ERAS protocols can reduce colorectal cancer-related mortality. The main objective of this study is to analyse the impact of an ERAS programme for colorectal cancer on 5-year survival. As secondary objectives, we propose to analyse the weight of each of the predefined items in the oncological results as well as the quality of life.Methods and analysisA multicentre prospective cohort study was conducted in patients older than 18 years of age who are scheduled to undergo surgery for colorectal cancer. The study involved 12 hospitals with an implemented enhanced recovery protocol according to the guidelines published by the Spanish National Health Service. The intervention group includes patients with a minimum implementation level of 70%, and the control group includes those who fail to reach this level. Compliance will be studied using 18 key performance indicators, and the results will be analysed using cancer survival indicators, including overall survival, cancer-specific survival and relapse-free survival. The time to recurrence, perioperative morbidity and mortality, hospital stay and quality of life will also be studied, the latter using the validated EuroQol Five questionnaire. The propensity index method will be used to create comparable treatment and control groups, and a multivariate regression will be used to study each variable. The Kaplan-Meier estimator will be used to estimate survival and the log-rank test to make comparisons. A p value of less than 0.05 (two-tailed) will be considered to be significant.Ethics and disseminationEthical approval for this study was obtained from the Aragon Ethical Committee (C.P.-C.I. PI20/086) on 4 March 2020. The findings of this study will be submitted to peer-reviewed journals (BMJ Open, JAMA Surgery, Annals of Surgery, British Journal of Surgery). Abstracts will be submitted to relevant national and international meetings.Trial registration numberNCT04305314.


2018 ◽  
Vol 36 (8) ◽  
pp. 749-756 ◽  
Author(s):  
Mary Jane Esplen ◽  
Jiahui Wong ◽  
Ellen Warner ◽  
Brenda Toner

Purpose This study aimed to test a group psychosocial intervention focused on improving disturbances of body image (BI), sexual functioning, and quality of life in breast cancer (BC) survivors. Methods A prospective, randomized controlled trial was conducted to assess the efficacy of an 8-week group intervention in women after BC treatment. The manual-based intervention combined two powerful ingredients: expressive guided-imagery exercises integrated within a model of group-therapy principles. The intervention facilitates exploration of identity, the development of new self-schemas, and personal growth. In addition, the intervention included an educational component on the social and cultural factors affecting women’s self-esteem and BI. The control condition included standard care plus educational reading materials. One hundred ninety-four BC survivors who had expressed concerns about negative BI and/or difficulties with sexual functioning participated in the study; 131 were randomly assigned to the intervention, and 63 were assigned to the control condition. Participants were followed for 1 year. Results Women in the intervention group reported significantly less concern/distress about body appearance ( P < .01), decreased body stigma ( P < .01), and lower level of BC−related concerns ( P < .01), compared with women in the control group. BC-related quality of life was also better in the intervention group compared with the control group at the 1-year follow-up ( P < .01). There was no statistically significant group difference in sexual functioning. Conclusion Restoring Body Image After Cancer (ReBIC), a group intervention using guided imagery within a group-therapy approach, is an effective method for addressing BI-related concerns and quality of life post-BC. The manual-based intervention can be easily adapted to both cancer centers and primary care settings.


Author(s):  
R. Rokkaku ◽  
A. Homma ◽  
S. Kobayashi ◽  
Y. Seki

This article summarizes the impact of inter-generational cooperation on the quality of life of elderly Alzheimer’s sufferers. The study is a continuing, two-year intervention and reports the results of the first year. It consists of an intervention and a control group of eight and six sufferers, respectively, who have been diagnosed with Alzheimer's disease. Both groups attend day care services. The intervention group participates in the inter-generational program with children, while the control group does not. On the Philadelphia Geriatric Center Affect Rating Scale, three items have been proved statistically significant. Pleasure, Interest, and Contentment have increased with inter-generational cooperation. The magnitude of the change was not so remarkable as to influence QOL-AD at home. However, the present results may imply a reduction on the burden of the day care service staff and family carers. Another advantage may be in the educating of the children’s parents, whose understanding of dementia was poor.


2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
D. McClurg ◽  
K. Walker ◽  
P. Aitchison ◽  
K. Jamieson ◽  
L. Dickinson ◽  
...  

Objectives.To explore the experiences of people with Parkinson’s (PwP) who suffer from constipation, the impact this has on their lives, and the effect of using lifestyle changes and abdominal massage as a form of constipation management.Method.Fourteen semistructured interviews were completed (8 males and 6 females; mean age 72.2 years) at the end of a care programme, which consisted of either lifestyle advice and abdominal massage (intervention group;n=7) or lifestyle advice only (control group;n=7). Data were analysed using constant-comparison techniques and Framework methods. Themes and key quotes were identified to depict major findings.Findings.Four key themes were identified: (i) the adverse impact of bowel problems on quality of life; (ii) positive experience of behaviour adjustments: experimentation; (iii) abdominal massage as a dynamic and relaxing tool: experiential learning (intervention group only); (iv) abdominal massage as a contingency plan: hesitation (control group only). Constipation was reported as having a significant impact on quality of life. Participants in both groups perceived lifestyle advice to relieve symptoms. Specific improvements were described in those who also received the abdominal massage.Conclusions.Both lifestyle advice and abdominal massage were perceived to be beneficial in relieving symptoms of constipation for PwP.


Author(s):  
R. Rokkaku ◽  
A. Homma ◽  
S. Kobayashi ◽  
Y. Seki

An aim of the present study is to examine the impact of inter-generational cooperation on the quality of life of elderly Alzheimer’s sufferers. The study is a continuing, two-year intervention report. The subject consist of an intervention and a control groups of six and five sufferers, respectively, who were diagnosed with Alzheimer’s disease. Both groups attend day care services. The intervention group participates in the inter-generational program with children, while the control group does not. In the results, the score of Quality of Life – Alzheimer’s disease (QOL-AD ) of the subjects has been significantly higher in the intervention group comparing with that of the control group. been significantly higher in the intervention group comparing with that of the control group. Also the Philadelphia Geriatric Center Affect Rating Scale(PGC-ARS), have been significantly higher in the intervention group those in the control group., The magnitude of the change was not so remarkable as to influence QOL-AD at home. The present intergenerational cooperation may improve the quality of life of moderate to severe Alzheimer’s sufferers.


2018 ◽  
Author(s):  
Nils Fischer ◽  
Stephen Agboola ◽  
Ramya Palacholla ◽  
Mursal Atif ◽  
Joseph Kvedar ◽  
...  

BACKGROUND CORA is a personalized smartphone-based self-management app designed to help cancer patients on oral anti-cancer medications manage medication, medication side-effects, and symptoms with the overall goal of improving their quality of life. OBJECTIVE To evaluate the effect of CORA on quality of life in patients on oral anti-cancer medications. METHODS Eighty-four patients were randomized to either an intervention group that received CORA plus usual care or a control group that received usual care. Quality of life was measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale administered at enrollment, 6 and 12 weeks. Engagement with the app was assessed by determining the unique days using the app. We evaluated the effect of engagement on FACIT-F both as a continuous variable (days using the app) and as a categorical outcome (low, medium, and high). Group differences for all outcomes over the study period were assessed using repeated measures mixed model analysis. RESULTS Relative to the control group, the intervention group improved FACIT-F by 0.36 (95% CI 0.10-0.61) P=.006 per week over the study period. As a continuous variable, each additional day using the app was significantly associated with an improved FACIT-F score per week in the study [0.0060 (95% CI -0.000034-0.012), P=.05]. Within the intervention group that used the app, those who were most engaged with the app were significantly more likely to improve their quality of life over the study relative to the least engaged group [0.37 per week (95% CI 0.19-1.94), P=.05]. CONCLUSIONS CORA may have significantly improved quality of life (FACIT-F) in cancer patients over 12 weeks. Smartphone applications may positively impact health and behavioral outcomes in cancer patients on oral anti-cancer medications.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Boris Trenado Luengo ◽  
Rosa García-Sierra ◽  
Maria Asunción Wilke Trinxant ◽  
Esther Díaz Mondelo ◽  
Ramon Miralles Baseda ◽  
...  

Abstract Background Detecting, treating and monitoring anaemia has a functional, social and economic impact on patients’ quality of life and the health system, since inadequate monitoring can lead to more accident & emergency visits and hospitalizations. The aim of this study is to evaluate the impact in the patient clinical outcomes of using haemoglobinometry to early detect anaemia in patients with chronic anaemia in primary care. Methods Randomized controlled trial Capillary haemoglobin will be measured using a haemoglobinometer on a monthly basis in the intervention group. In the control group, the protocol currently in force at the primary care centre will be followed and venous haemoglobin will be measured. Any cases of anaemia detected in either group will be referred to the transfusion circuit of the reference hospital. Discusion The results will shed light on the impact of the intervention on the volume of hospitalizations and accident & emergency (A&E) visits due to anaemia, as well as patients’ quality of life. Chronic and repeated bouts of anaemia are detected late, thus leading to decompensation in chronic diseases and, in turn, more A&E visits and hospitalizations. The intervention should improve these outcomes since treatment could be performed without delay. Improving response times would decrease decompensation in chronic diseases, as well as A&E visits and hospitalizations, and improve quality of life. The primary care nurse case manager will perform the intervention, which should improve existing fragmentation between different care levels. Trial registration NCT04757909. Registered 17 February 2021. Retrospectively registered.


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