scholarly journals The effectiveness of a multi-strategy behavioral intervention to increase the nutritional quality of primary school students’ online canteen lunch orders: The ‘Click & Crunch’ cluster randomized controlled trial (Preprint)

10.2196/26054 ◽  
2020 ◽  
Author(s):  
Rebecca Wyse ◽  
Tessa Delaney ◽  
Fiona G. Stacey ◽  
Rachel Zoetemeyer ◽  
Christophe Lecathelinais ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary School ◽  
Behavioral Intervention ◽  
Nutritional Quality ◽  
Controlled Trial ◽  
Primary School Students ◽  
School Students ◽  
Randomized Controlled ◽  
Cluster Randomized

scholarly journals A tablet-based intervention for activating nursing home residents with dementia: results from a cluster-randomized controlled trial

2021 ◽  
pp. 1-13
Author(s):  
Julie L. O’Sullivan ◽  
Sonia Lech ◽  
Paul Gellert ◽  
Ulrike Grittner ◽  
Jan-Niklas Voigt-Antons ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Nursing Homes ◽  
Psychotropic Medication ◽  
Controlled Trial ◽  
Nursing Home Residents ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Objectives: To investigate global and momentary effects of a tablet-based non-pharmacological intervention for nursing home residents living with dementia. Design: Cluster-randomized controlled trial. Setting: Ten nursing homes in Germany were randomly allocated to the tablet-based intervention (TBI, 5 units) or conventional activity sessions (CAS, 5 units). Participants: N = 162 residents with dementia. Intervention: Participants received regular TBI (n = 80) with stimulating activities developed to engage people with dementia or CAS (n = 82) for 8 weeks. Measurements: Apathy Evaluation Scale (AES-I, primary outcome), Quality of Life in Alzheimer’s Disease scale, QUALIDEM scale, Neuropsychiatric Inventory, Geriatric Depression Scale, and psychotropic medication (secondary outcomes). Momentary quality of life was assessed before and after each activity session. Participants and staff were blinded until the collection of baseline data was completed. Data were analyzed with linear mixed-effects models. Results: Levels of apathy decreased slightly in both groups (mean decrease in AES-I of .61 points, 95% CI −3.54, 2.33 for TBI and .36 points, 95% CI −3.27, 2.55 for CAS). Group difference in change of apathy was not statistically significant (β = .25; 95% CI 3.89, 4.38, p = .91). This corresponds to a standardized effect size (Cohen’s d) of .02. A reduction of psychotropic medication was found for TBI compared to CAS. Further analyses revealed a post-intervention improvement in QUALIDEM scores across both groups and short-term improvements of momentary quality of life in the CAS group. Conclusions: Our findings suggest that interventions involving tailored activities have a beneficial impact on global and momentary quality of life in nursing home residents with dementia. Although we found no clear advantage of TBI compared to CAS, tablet computers can support delivery of non-pharmacological interventions in nursing homes and facilitate regular assessments of fluctuating momentary states.

scholarly journals Evaluation of a Brief Intervention for Promoting Mental Health among Employees in Social Enterprises: A Cluster Randomized Controlled Trial

2018 ◽  
Vol 15 (10) ◽  
pp. 2107 ◽  
Author(s):  
Benedicte Deforche ◽  
Jasmine Mommen ◽  
Anne Hublet ◽  
Winnie De Roover ◽  
Nele Huys ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Health Promotion ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Social Enterprises ◽  
Randomized Controlled ◽  
Cluster Randomized

Evidence on the effectiveness of workplace mental health promotion for people with disabilities is limited. This study aimed to evaluate the effectiveness of a brief mental health promotion intervention in social enterprises. It had a non-blinded cluster randomized controlled trial design with follow-up one and four months after the intervention. In total 196 employees agreed to participate (86 intervention and 110 control). Empowerment was the main outcome; secondary outcomes were resilience, palliative behavior, determinants of four coping strategies of mental health, quality of life, and life satisfaction. A brief participant satisfaction survey was conducted after the intervention. No significant intervention effect on empowerment was found. However, at one month follow-up, significant favorable effects were found on perceived social support for coping strategies for mental health and on palliative behavior. At four months follow-up, favorable intervention effects were found on quality of life, but unfavorable effects were found on unjustified worrying. In addition, the intervention was well received by the employees. This brief intervention might be a promising first step to improve mental health in people with disabilities working in social enterprises. Nevertheless, additional monitoring by professionals and managers working in the organizations might be needed to maintain these effects.

scholarly journals Effects of sanitary pad distribution and reproductive health education on upper primary school attendance and reproductive health knowledge and attitudes in Kenya: a cluster randomized controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Karen Austrian ◽  
Beth Kangwana ◽  
Eunice Muthengi ◽  
Erica Soler-Hampejsek
Keyword(s):  
Randomized Controlled Trial ◽  
Reproductive Health ◽  
Primary School ◽  
School Attendance ◽  
Controlled Trial ◽  
Gender Norms ◽  
Primary Grade ◽  
Randomized Controlled ◽  
Knowledge And Attitudes ◽  
Cluster Randomized

Abstract Background Adolescent girls’ risk of school dropout and reproductive health (RH) challenges may be exacerbated by girls’ attitudes toward their bodies and inability to manage their menstruation. We assessed effects of sanitary pad distribution and RH education on girls in primary grade 7 in Kilifi, Kenya. Methods A cluster randomized controlled trial design was used. Eligible clusters were all non-boarding schools in three sub-counties in Kilifi County that had a minimum of 25 girls enrolled in primary grade 7. 140 primary schools, 35 per arm, were randomly assigned to one of four study arms: (1) control; (2) sanitary pad distribution; (3) RH education; or (4) both sanitary pad distribution and RH education. Outcomes were school attendance, school engagement, RH knowledge and attitudes, gender norms, and self-efficacy. For outcomes measured both at baseline and endline, difference-in-differences (DID) models were estimated and for outcomes without baseline data available, analysis of covariance models were used. Results The study enrolled 3489 randomly selected girls in primary grade 7, with a mean age of 14.4 (SD 1.5). Girls in arms 2 and 4 received on average 17.6 out of 20 packets of sanitary pads and girls in arms 3 and 4 participated on average in 21 out of 25 RH sessions. Ninety-four percent of the baseline sample was interviewed at the end of the intervention with no differential attrition by arm. There was no evidence of an effect on primary school attendance on arm 2 (coefficient [coef] 0.37, 95% CI − 0.73, 1.46), arm 3 (coef 0.14, 95% CI − 0.99, 1.26) or arm 4 (coef 0.58, 95% CI − .37, 1.52). There was increased positive RH attitudes for girls in arm 3 (DID coef. 0.63, 95% CI 0.40–0.86) and arm 4 (DID coef. 0.85, 95% CI 0.64, − 1.07). There was also an increase in RH knowledge, gender norms and self-efficacy in arms 3 and 4. Conclusions The findings suggest that neither sanitary pad distribution nor RH education, on their own or together, were sufficient to improve primary school attendance. However, as the RH education intervention improved RH outcomes, the evidence suggests that sanitary pad distribution and RH education can be positioned in broader RH programming for girls. Trial registration: ISRCTN, ISRCTN10894523. Registered 22 August 2017—Retrospectively registered, http://www.isrctn.com/ISRCTN10894523

scholarly journals Efficacy of a Web-Enabled, School-Based, Preventative Intervention to Reduce Bullying and Improve Mental Health in Children and Adolescents: Study Protocol for a Cluster Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Covadonga M. Díaz-Caneja ◽  
Javier Martín-Babarro ◽  
Renzo Abregú-Crespo ◽  
Miguel Á. Huete-Diego ◽  
Marta Giménez-Dasí ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Bullying Victimization ◽  
Randomized Controlled ◽  
School Based ◽  
Cluster Randomized

Introduction: Bullying is a major preventable risk factor for mental disorders. Available evidence suggests school-based interventions reduce bullying prevalence rates. This study aims to test the efficacy of a web-enabled, school-based, multicomponent anti-bullying intervention to prevent school bullying and to assess its effects on mental health and quality of life.Methods and analysis: Cluster randomized controlled trial conducted in 20 publicly funded primary and secondary schools in Madrid, Spain. Schools are randomly allocated to either the intervention arm (n = 10) or conventional practices arm (n = 10). The web-enabled intervention (LINKlusive) lasts ~12 weeks and consists of three main components: (i) an online training program for teachers and parents, (ii) a web-guided educational program for students, focusing on promoting respect for diversity, empathy, and social skill development, and (iii) a web-guided, teacher-delivered, targeted intervention program for bullying situations identified based on peer-support strategies and individual intervention for those involved (i.e., bullying victims and perpetrators). The primary objective is to compare differences between peer-reported bullying victimization in the intervention and control arms at the end of the intervention. Secondary outcome measures are additional measures of bullying victimization and perpetration, mental health symptoms, self-esteem, and quality of life. A follow-up assessment is conducted 1 year after the end of the intervention. Treatment effects will be tested using multilevel mixed models, adjusting for school-, classroom-, and student-related covariates. Considering the increased bullying rates in children with special educational needs, a specific subgroup analysis will test the efficacy of the intervention on bullying prevalence, mental health, and quality of life in this particularly vulnerable population.Ethics and Dissemination: The Deontology Commission of the School of Psychology, Universidad Complutense in Madrid, Spain reviewed the study protocol and granted ethical approval on 21st January 2019. The results of the trial will be disseminated in relevant peer-reviewed journals and at conferences in the field.Trial Registration Number: ISRCTN15719015.

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