scholarly journals Impact of group-based dietary education on the dietary habits of female adolescents: a cluster randomized trial

2010 ◽  
Vol 14 (4) ◽  
pp. 702-708 ◽  
Author(s):  
Kazue Yamaoka ◽  
Mariko Watanabe ◽  
Eisuke Hida ◽  
Toshiro Tango
Keyword(s):  
Dietary Intake ◽  
Energy Intake ◽  
Young Women ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Female Adolescents ◽  
Control Group ◽  
Dietary Education ◽  
Cluster Randomized

AbstractObjectiveThe number of extremely thin young women has increased and education at school on maintaining an optimal weight has become important. The aim of the present study was to assess the effectiveness of a group-based home-collaborative dietary education (HCDE) programme to maintain appropriate dietary intake compared to conventional school classroom education.DesignTwo-arm cluster randomized controlled trial. Twelve classes were randomly assigned as clusters to either the HCDE group or the control group. Each participant in the HCDE group received twelve sessions of group counselling aimed at increasing energy intake at breakfast by modifying dietary intake and adopting appropriate habits. The hypothesis underlying the study was that after 6 months of HCDE the total energy intake would be increased by 627 kJ from baseline (primary endpoint). Secondary outcomes were differences in intake of various nutrients from baseline. Outcome measures after log transformation were examined by t tests and linear mixed models (crude and baseline-adjusted).SettingYoung women among Japanese female adolescents in Tokyo.SubjectsFour hundred and seventy-four participants aged 13–15 years.ResultsStudents in twelve classes were used for analysis (n 459). Energy intake was decreased in many of the classes during the 6-month period, especially for those in the control group. After adjustment for the baseline value, significant increases in energy intake and protein, calcium, magnesium and iron intakes at breakfast were observed (P < 0·05)ConclusionsAlthough energy intake was increased in the HCDE group compared to the control group, further study of the HCDE is warranted.

Effect of a Community-led Total Sanitation Intervention on the Incidence and Prevalence of Diarrhea in Children in Rural Ethiopia: A Cluster-randomized Controlled Trial

2021 ◽  
Author(s):  
Seungman Cha ◽  
Sunghoon Jung ◽  
Dawit Belew Bizuneh ◽  
Tadesse Abera ◽  
Young-Ah Doh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Prevalence Ratio ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Period Prevalence ◽  
Rural Villages ◽  
Diary Methods ◽  
Diarrhea Incidence ◽  
Cluster Randomized

We conducted a cluster-randomized trial in 48 rural villages of Ethiopia to assess the effect of community-led total sanitation (CLTS) on the diarrhea incidence of children. Twenty-four villages were randomly assigned to the intervention group and the other 24 were assigned to the control group. A CLTS intervention was implemented from January 2016 through January 2017. Baseline data collection was conducted during October and November 2015. At baseline, 906 children were recruited and followed-up until January 2017. These 906 children were randomly selected among all children in the 48 villages. To determine the 7-day period prevalence of diarrhea, four household-based surveys were conducted by independent data collectors at 3, 5, 9, and 10 months after the CLTS was initiated. To determine the incidence and longitudinal prevalence, the presence of daily diarrhea presence was recorded for 140 days using diary methods. The loss to follow-up rates were 95% for period prevalence and 93% for incidence and longitudinal prevalence. The incidence ratio and longitudinal prevalence ratio were 0.66 (95% confidence interval [CI], 0.45–0.97; P = 0.03) and 0.70 (95% CI, 0.52–0.95; P = 0.02) after adjusting for clustering and stratification. The relative risk of period prevalence was 0.66 (95% CI, 0.45–0.98; P = 0.04) at 3 months after initiation. Improved toilet coverage increased from 0.0% at baseline to 35.0% at 10 months in the intervention villages, whereas it increased from 0.7% to 2.8% in the control villages. Adherence to the intervention was comparable with that of previous studies; therefore, we suggest that the findings of this study are replicable.

Apathy in Nursing Home Residents with Dementia: Results From A Cluster-Randomized Controlled Trial

2015 ◽  
Vol 30 (2) ◽  
pp. 251-257 ◽  
Author(s):  
Y. Treusch ◽  
T. Majic ◽  
J. Page ◽  
H. Gutzmann ◽  
A. Heinz ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Nursing Home Residents ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Intervention Period ◽  
Significant Group ◽  
Dementia Patients ◽  
Cluster Randomized ◽  
One Year

AbstractPurpose:Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy.Subjects and methods:A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n = 117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months.Results:We found significant group differences with respect to apathy during the 10 month intervention period (F2,82 = 7.79, P < 0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P = 0.55).Conclusions:Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy.

scholarly journals A cluster-randomized trial determining the efficacy of caterpillar cereal as a locally available and sustainable complementary food to prevent stunting and anaemia

2015 ◽  
Vol 18 (10) ◽  
pp. 1785-1792 ◽  
Author(s):  
Melissa Bauserman ◽  
Adrien Lokangaka ◽  
Justin Gado ◽  
Kelly Close ◽  
Dennis Wallace ◽  
...  
Keyword(s):  
Democratic Republic ◽  
Democratic Republic Of Congo ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Republic Of Congo ◽  
High Prevalence ◽  
Cluster Randomized ◽  
Hb Concentration ◽  
And Control

AbstractObjectiveWe conducted a cluster-randomized controlled trial to assess the efficacy of a cereal made from caterpillars, a micronutrient-rich, locally available alternative animal-source food, on reducing stunting and anaemia in infants in the Democratic Republic of Congo.DesignSix-month-old infants were cluster randomized to receive either caterpillar cereal daily until 18 months of age or the usual diet. At 18 months of age, anthropometric measurements and biological samples were collected.SettingThe rural Equateur Province in the Democratic Republic of Congo.SubjectsOne hundred and seventy-five infants followed from 6 to 18 months of age.ResultsStunting was common at 6 months (35 %) and the prevalence increased until 18 months (69 %). There was no difference in stunting prevalence at 18 months between the intervention and control groups (67 % v. 71 %, P=0·69). Infants in the cereal group had higher Hb concentration than infants in the control group (10·7 v. 10·1 g/dl, P=0·03) and fewer were anaemic (26 v. 50 %, P=0·006), although there was no difference in estimates of body Fe stores (6·7 v. 7·2 mg/kg body weight, P=0·44).ConclusionsSupplementation of complementary foods with caterpillar cereal did not reduce the prevalence of stunting at 18 months of age. However, infants who consumed caterpillar cereal had higher Hb concentration and fewer were anaemic, suggesting that caterpillar cereal might have some beneficial effect. The high prevalence of stunting at 6 months and the lack of response to this micronutrient-rich supplement suggest that factors other than dietary deficiencies also contribute to stunting.

Impact of a store-and-forward teledermatology intervention versus usual care on delay before beginning treatment: A pragmatic cluster-randomized trial in ambulatory care

2016 ◽  
Vol 23 (8) ◽  
pp. 725-732 ◽  
Author(s):  
Edouard Piette ◽  
Michel Nougairède ◽  
Valerie Vuong ◽  
Beatrice Crickx ◽  
Viet-Thi Tran
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Skin Lesions ◽  
Control Group ◽  
Referral Letter ◽  
Open Label ◽  
Clinical Images ◽  
Store And Forward ◽  
Cluster Randomized

Introduction In France, 66% of patients forego getting specialized care by dermatologists because of difficulty obtaining appointments. Store-and-forward teledermatology could improve how promptly treatment begins by reducing the delay in obtaining a specialist’s opinion. In this study, we compared the delay before care between general practitioners (GPs) using a store-and-forward teledermatology intervention and GPs addressing their patients with a standard referral letter. Methods We performed an open-label, pragmatic cluster-randomized controlled trial with two parallel arms. GP clinics in Paris (France) were randomly assigned to use either teledermatology referral (use of electronics to send clinical images taken using a mobile phone) or conventional referral (using standard letters) to care for patients for whom a dermatologist’s advice was needed for the diagnosis or treatment of skin lesions. Dermatologists integrated responses to teledermatology requests in their usual schedule. Patients were followed up for three months. Primary outcome was the delay, in days, between the GP’s consultation and a reply by the specialist allowing treatment to begin. Analyses were adjusted for clustering of GPs and identities of dermatologists. Results Between February and June 2014, 103 patients were included in the study (53 patients of 20 GPs in the intervention group). The median delay between the initial GP’s consultation and the reply allowing for treatment to begin was four days in the intervention group and 40 days in the control group (adjusted hazard ratio = 2.55; p < 0.011). Discussion We showed that a simple store-and-forward teledermatology intervention significantly reduced the delay before beginning care (ClinicalTrials.gov identifier: NCT02122432).

scholarly journals Assessing Validity of Self-Reported Dietary Intake within a Mediterranean Diet Cluster Randomized Controlled Trial among US Firefighters

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2250 ◽  
Author(s):  
Mercedes Sotos-Prieto ◽  
Costas Christophi ◽  
Alicen Black ◽  
Jeremy D Furtado ◽  
Yiqing Song ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pilot Study ◽  
Dietary Intake ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Omega 3 ◽  
Randomized Controlled ◽  
Cluster Randomized

Collecting dietary intake data is associated with challenges due to the subjective nature of self–administered instruments. Biomarkers may objectively estimate the consumption of specific dietary items or help assess compliance in dietary intervention studies. Our aim was to use a panel of plasma and urine biomarkers to assess the validity of self-reported dietary intake using a modified Mediterranean Diet Scale (mMDS) among firefighters participating in Feeding America’s Bravest (FAB), an MD cluster-randomized controlled trial. In our nested biomarker pilot study, participants were randomly selected from both the MD intervention group (n = 24) and the control group (n = 24) after 12-months of dietary intervention. At baseline data collection for the pilot study (t = 12-months of FAB), participants in the control group crossed-over to receive the MD intervention (active intervention) for 6-months. Participants in the intervention group continued in a self-sustained continuation phase (SSP) of the intervention. Food frequency questionnaires (FFQ), 13-item-mMDS questionnaires, 40 plasma fatty acids, inflammatory biomarkers and urinary hydroxytyrosol and tyrosol were analyzed at both time points. Spearman’s correlation, t-tests and linear regression coefficients were calculated using SAS software. Overall, the mMDS derived from the FFQ was highly correlated with the specific 13-domain-mMDS (r = 0.74). The concordance between the two questionnaires for low and high adherence to MD was high for all the participants in the parent trial (κ = 0.76). After 6 months of intervention in the pilot study, plasma saturated fatty acid decreased in both groups (active intervention: −1.3 ± 1.7; p = 0.002; SSP: −1.12 ± 1.90; p = 0.014) and oleic acid improved in the SSP (p = 0.013). Intake of olive oil was positively associated with plasma omega-3 (p = 0.004) and negatively with TNF-α (p < 0.001) at baseline. Choosing olive oil as a type of fat was also associated with higher levels of plasma omega-3 (p = 0.019) at baseline and lower TNF-α (p = 0.023) at follow up. Intake of red and processed meats were associated with lower serum omega-3 (p = 0.04) and fish consumption was associated with lower IL-6 at baseline (p = 0.022). The overall mMDS was associated with an increase in plasma omega-3 (p = 0.021). Good correlation was found between nutrient intake from the FFQ and the corresponding plasma biomarkers (omega-3, EPA and DHA). In this MD randomized controlled trial, some key plasma biomarkers were significantly associated with key MD diet components and the overall mMDS supporting the validity of the mMDS questionnaire as well as compliance with the intervention.

scholarly journals Can Garfield make children eat healthier?: A cluster-randomized controlled trial to examine the effect of a serious health game on children’s eating behavior. (Preprint)

2019 ◽  
Author(s):  
Frans Folkvord ◽  
Gosse Hage ◽  
Alexandra Theben
Keyword(s):  
Randomized Controlled Trial ◽  
Dietary Intake ◽  
Eating Behavior ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Dietary Guidelines ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Currently the dietary intake patterns of children do not meet the prescribed dietary guidelines. Consequently childhood obesity is one of the most serious health concerns and innovative methods need to be developed and tested in order effectively improve the dietary intake of children. Learning children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games. OBJECTIVE The main aim of this study was to examine the effect of a serious health computer game on young children’s eating behavior and attitudes towards healthy and unhealthy foods. METHODS A cluster-randomized controlled trial with a between-subject design was conducted (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were in the control condition. The game was designed in collaboration with researchers and pilot-tested before conducting the experiment among a group of children repeatedly. After one week of playing, attitudes towards food snacks and actual intake was assessed, whereby children could eat at libitum from fruits or energy-dense snacks. RESULTS The results showed that playing a serious health game did not have an effect on the attitude towards fruits or energy-dense snacks and on the intake of fruits or less energy-dense snacks, compared to the control group. Additional Bayesian analyses supported these findings. CONCLUSIONS Serious health games are increasingly considered as a potential effective intervention technique when it comes to behavioral change. The results of the current study stress the importance to tailor serious health games in order to be effective, because no effect was found on attitude or eating behavior.

scholarly journals Collaborative care for depression in UK primary care: a randomized controlled trial

2007 ◽  
Vol 38 (2) ◽  
pp. 279-287 ◽  
Author(s):  
D. A. Richards ◽  
K. Lovell ◽  
S. Gilbody ◽  
L. Gask ◽  
D. Torgerson ◽  
...  
Keyword(s):  
Primary Care ◽  
Collaborative Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Phase Iii ◽  
Control Group ◽  
Randomized Control ◽  
Cluster Randomized

BackgroundCollaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial.MethodWe undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to ‘collaborative care’ – case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication – or a usual care control. The primary outcome was symptoms of depression (PHQ-9).ResultsWe recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18–1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (−2.99, 95% CI −7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (−4.64, 95% CI −7.93 to −1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00–0.32).ConclusionsCollaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.

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.

Effects of Teaching Resourcefulness in Patients with Coronary Heart Disease

2021 ◽  
pp. 019394592110207
Author(s):  
Min Wen ◽  
Yaqin Liang ◽  
Qianqian Shen ◽  
Juping Yu ◽  
Pingping He ◽  
...  
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Health Education ◽  
Controlled Trial ◽  
Coping Styles ◽  
Intervention Group ◽  
Control Group ◽  
Convenience Sample ◽  
Cluster Randomized ◽  
And Coping

This cluster randomized controlled trial aimed to investigate the effects of an intervention to teach resourcefulness on depression and coping style of patients with coronary heart disease (CHD). A convenience sample of 72 patients in community settings took part. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both ps < .001). The findings suggest that a well-developed intervention to teach resourcefulness could help patients with CHD to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.

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