• Title/Summary/Keyword: Intervention trial

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Review of Early Intervention for Children with Autism Spectrum Disorder: Focused on Randomized Controlled Trials

  • Yang, Young-Hui
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.30 no.4
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    • pp.136-144
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    • 2019
  • Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses. However, there have been a few robust evidences for effectiveness of early intervention until now. This review aims to identify the effectiveness of early intervention by investigating the randomized controlled trial (RCT) of early intervention for autism. There are some RCT studies using behavioral program. Although there are some significant findings, the outcome measurements and small sample size are the limitations. Further studies are needed.

Intervention to Improve Menstrual Health Among Adolescent Girls Based on the Theory of Planned Behavior in Iran: A Cluster-randomized Controlled Trial

  • Fatemeh, Darabi;Mehdi, Yaseri
    • Journal of Preventive Medicine and Public Health
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    • v.55 no.6
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    • pp.595-603
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    • 2022
  • Objectives: Poor menstrual health may lead to school absenteeism and adverse health outcomes for adolescents. The purpose of this study was to determine the effect of pubertal and menstrual health education on health and preventive behaviors among Iranian secondary school girls. Methods: A quasi-experimental study was conducted to evaluate the effectiveness of a health intervention program. A total of 578 students (including intervention and control participants) in 12 schools in Tehran Province, Iran were included by multistage random sampling. The program comprised seven 2-hour educational sessions. After confirming the reliability and validity of a researcher-made questionnaire, that questionnaire was used to collect the required data, and the groups were followed up with after 6 months. Results: After the educational intervention, the mean scores of menstrual health-related knowledge and constructs of the theory of planned behavior were significantly higher in the intervention group than in the control group (p<0.001 for all dimensions). Conclusions: The results of this study emphasize the effectiveness of menstrual health interventions in schools. These findings should also encourage health policy-makers to take committed action to improve performance in schools.

The effects of dietary self-monitoring intervention on anthropometric and metabolic changes via a mobile application or paper-based diary: a randomized trial

  • Taiyue Jin;Gyumin Kang;Sihan Song;Heejin Lee;Yang Chen;Sung-Eun Kim;Mal-Soon Shin;Youngja H Park;Jung Eun Lee
    • Nutrition Research and Practice
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    • v.17 no.6
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    • pp.1238-1254
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    • 2023
  • BACKGROUND/OBJECTIVES: Weight loss via a mobile application (App) or a paper-based diary (Paper) may confer favorable metabolic and anthropometric changes. SUBJECTS/METHODS: A randomized parallel trial was conducted among 57 adults whose body mass indices (BMIs) were 25 kg/m2 or greater. Participants randomly assigned to either the App group (n = 30) or the Paper group (n = 27) were advised to record their foods and supplements through App or Paper during the 12-week intervention period. Relative changes of anthropometries and biomarker levels were compared between the 2 intervention groups. Untargeted metabolic profiling was identified to discriminate metabolic profiles. RESULTS: Out of the 57 participants, 54 participants completed the trial. Changes in body weight and BMI were not significantly different between the 2 groups (P = 0.11). However, body fat and low-density lipoprotein (LDL)-cholesterol levels increased in the App group but decreased in the Paper group, and the difference was statistically significant (P = 0.03 for body fat and 0.02 for LDL-cholesterol). In the metabolomics analysis, decreases in methylglyoxal and (S)-malate in pyruvate metabolism and phosphatidylcholine (lecithin) in linoleic acid metabolism from pre- to post-intervention were observed in the Paper group. CONCLUSIONS: In the 12-week randomized parallel trial of weight loss through a App or a Paper, we found no significant difference in change in BMI or weight between the App and Paper groups, but improvement in body fatness and LDL-cholesterol levels only in the Paper group under the circumstances with minimal contact by dietitians or health care providers.

Wheel of Wellness Counseling in Community Dwelling, Korean Elders: A Randomized, Controlled Trial

  • Kwon, So-Hi
    • Journal of Korean Academy of Nursing
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    • v.45 no.3
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    • pp.459-468
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    • 2015
  • Purpose: The purpose of this study was to investigate the effects of Wheel of Wellness counseling on wellness lifestyle, depression, and health-related quality of life in community dwelling elderly people. Methods: A parallel, randomized controlled, open label, trial was conducted. Ninety-three elderly people in a senior welfare center were randomly assigned to two groups: 1) A Wheel of Wellness counseling intervention group (n=49) and 2) a no-treatment control group (n=44). Wheel of Wellness counseling consisted of structured, individual counseling based on the Wheel of Wellness model and provided once a week for four weeks. Wellness lifestyle, depression, and health-related quality of life were assessed pre-and post-test in both groups. Results: Data from 89 participants were analyzed. For participants in the experimental group, there was a significant improvement on all of the wellness-lifestyle subtasks except realistic beliefs. Perceived wellness and depression significantly improved after the in the experimental group (n=43) compared to the control group (n=46) from pre- to post-test in the areas of sense of control (p =.033), nutrition (p =.017), exercise (p =.039), self-care (p <.001), stress management (p =.017), work (p =.011), perceived wellness (p =.019), and depression (p =.031). One participant in the intervention group discontinued the intervention due to hospitalization and three in the control group discontinued the sessions. Conclusions: Wheel of Wellness counseling was beneficial in enhancing wellness for the community-dwelling elderly people. Research into long-term effects of the intervention and health outcomes is recommended.

The Suggestion for Clinical Trial of Face Rejuvenation using Korean Medicine's Embedded Needle (Maesun) Based on Literature Review (매선을 활용한 한의 안면 성형 임상 연구 설계 제안 -한의 안면 성형 임상연구 동향 분석을 바탕으로-)

  • Lee, Jae-Chul;Lim, Chang-Gyu;Kim, Jung-Won;Park, Sun-Hee;Yoon, Jeong-Ho
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.2
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    • pp.78-87
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    • 2013
  • Objectives : This work aimed to review clinical trial trend of Korean medicine's face rejuvenation and suggest future trial using embedded needle(Maesun) based on Evidence-based medicine's PICO Model. Methods : 46 papers were searched from Oasis and DBPia, then 8 papers were engaged in review of clinical trial trend. Based on PICO model, clinical trial's patient, intervention, and outcome measurement were suggested. Results : Evidence level of clinical trials is relatively low, because their study designs are almost case report or case series. No study have comparison groups. Outcome measurement is varied, however, 3D face scanner were used to measure before-after changes of face. Based on review, we suggested that necessity of intervention standardization, measuring of normal control group and 2D/3D combined outcome measurement of face. Conclusions : There are many demands for revealing efficacy and safety of Korean medicine's intervention, also for face rejuvenation using embedded needle. For meeting the level of demands, more rigorous works are needed.

Effectiveness of a Brief Physician Counselling Session on Improving Smoking Behaviour in the Workplace

  • Han, Yung Wen;Mohammad, Mohazmi;Liew, Su May
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.17
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    • pp.7287-7290
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    • 2014
  • Background: Brief physician counselling has been shown to be effective in improving smokers' behaviour. If the counselling sessions can be given at the workplace, this would benefit a larger number of smokers. This study aimed to determine the effectiveness of a ten-minute physician counseling session at the workplace in improving smoking behaviour. Materials and Methods: This prospective randomised control trial was conducted on smokers in a factory. A total of 163 participants were recruited and randomised into control and intervention groups using a table of random numbers. The intervention group received a ten-minute brief physician counselling session to quit smoking. Stages of smoking behaviour were measured in both groups using a translated and validated questionnaire at baseline, one month and three months post intervention. Results: There was a significant improvement in smoking behaviour at one-month post intervention (p=0.024, intention to treat analysis; OR=2.525; CI=1.109-5.747). This was not significant at three-month post intervention (p=0.946, intention to treat analysis; OR=1.026; 95% CI=0.486-2.168). Conclusions: A session of brief physician counselling was effective in improving smokers' behaviour at workplace, but the effect was not sustained.

Cost Effectiveness of Interventions to Promote Screening for Colorectal Cancer: A Randomized Trial

  • Misra, Swati;Lairson, David R.;Chan, Wenyaw;Chang, Yu-Chia;Bartholomew, L. Kay;Greisinger, Anthony;Mcqueen, Amy;Vernon, Sally W.
    • Journal of Preventive Medicine and Public Health
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    • v.44 no.3
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    • pp.101-110
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    • 2011
  • Objectives: Screening for colorectal cancer is considered cost effective, but is underutilized in the U.S. Information on the efficiency of "tailored interventions" to promote colorectal cancer screening in primary care settings is limited. The paper reports the results of a cost effectiveness analysis that compared a survey-only control group to a Centers for Disease Control (CDC) web-based intervention (screen for life) and to a tailored interactive computer-based intervention. Methods: A randomized controlled trial of people 50 and over, was conducted to test the interventions. The sample was 1224 partcipants 50-70 years of age, recruited from Kelsey-Seybold Clinic, a large multi-specialty clinic in Houston, Texas. Screening status was obtained by medical chart review after a 12-month follow-up period. An "intention to treat" analysis and micro costing from the patient and provider perspectives were used to estimate the costs and effects. Analysis of statistical uncertainty was conducted using nonparametric bootstrapping. Results: The estimated cost of implementing the web-based intervention was $40 per person and the cost of the tailored intervention was $45 per person. The additional cost per person screened for the web-based intervention compared to no intervention was $2602 and the tailored intervention was no more effective than the web-based strategy. Conclusions: The tailored intervention was less cost-effective than the web-based intervention for colorectal cancer screening promotion. The web-based intervention was less cost-effective than previous studies of in-reach colorectal cancer screening promotion. Researchers need to continue developing and evaluating the effectiveness and costeffectiveness of interventions to increase colorectal cancer screening.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer] (위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo
    • The Journal of Korean Medicine
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    • v.38 no.3
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    • pp.124-142
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    • 2017
  • Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

Cognitive Strategy Intervention Affects Performance Skills of Daily Living in Individuals with Stroke: A Randomized Controlled Trial (뇌졸중 환자의 인지적 전략개발 중심 중재가 수행기술에 미치는 효과 비교 : 무작위 비교연구)

  • Ahn, Si-Nae
    • The Korean Journal of Health Service Management
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    • v.10 no.3
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    • pp.75-84
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    • 2016
  • Objectives : The aim of this study was to compare a treatment focusing on the physical function to an intervention focusing on a cognitive strategy in stroke patients which improves their performance skills of daily activities. Methods : This study design was a randomized control trial selecting 43 people with stroke patients. This study consisted of a control group, which received conventional occupational therapy focusing on physical function, and an experimental group which was trained to develop a cognitive strategy by themselves. Both groups each received 10 sessions of the treatment. This study compared the skills for performing daily activities before and after the intervention and analyzed the data with SPSS Ver. 18.0. Results : This study showed a significant improvement in all performance skills in the experimental group (p<.05). There was no statistically significant difference in the performance skills before and after the intervention in the control group (p>.05). Conclusions : It was verified that stroke patients to develop a cognitive strategy by themselves is more effective than to improve the physical function in performance skills for daily activities.

Effectiveness of Nutrition Education in Improving Maternal Knowledge and Attitudes towards Complementary Feeding Practices: A cluster-randomized controlled trial in Ondo State, Nigeria

  • Akinrinmade, Remilekun;NJOGU, Eunice;OGADA, Irene Awuor;KESHINRO, Olufunke Oluremi
    • The Korean Journal of Food & Health Convergence
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    • v.5 no.4
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    • pp.1-10
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    • 2019
  • Significant low knowledge and poor attitudes on complementary feeding undermine the practices. This study was a cluster randomized controlled trial in which 284 study participants were assigned into two groups. One intervention group and a control group in a ratio of 1:1. Nutrition education on complementary feeding was carried out among the caregivers in the intervention group but the caregivers in the control group were not educated. To determine complementary feeding knowledge and attitudes, data was collected from caregiver at baseline, midline and at endline using researcher-administered questionnaires. Quantitative data were analyzed using SPSS version 22.0. From the analysis, there was a significant difference in complementary feeding knowledge of the caregivers after the intervention. The baseline difference was -0.06, the midline difference was 3.85 the endline difference was 4.00 and the DID of the baseline and endline was 4.06 which was significant at p=0.001. There was a significant difference in the attitude of the caregivers towards complementary feeding at baseline (-0.14), midline (2.09), endline (3.82) and the DID of baseline and endline was 3.96 which was significant at p=0.001. The intervention improved the caregivers' knowledge on complementary feeding and it improved the attitudes of the caregivers towards adequate complementary feeding.