scholarly journals Does the consumption of amylase-containing gruels impact on the energy intake and growth of Congolese infants?

2003 ◽  
Vol 6 (3) ◽  
pp. 249-257 ◽  
Author(s):  
M Moursi ◽  
F Mbemba ◽  
S Trèche
Keyword(s):  
Breast Milk ◽  
Energy Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Milk Consumption ◽  
Control Groups ◽  
Daily Energy ◽  
Randomised Controlled ◽  
And Control

AbstractObjective:To assess the effect of the incorporation of amylase in maize-based flours prepared as gruels on the energy intake and growth of Congolese infants.Design:A randomised controlled trial. At 18 weeks of age, infants were randomised into either an intervention group, where they were provided with a maize/soya-based flour that contained amylase, or a control group, where they were provided with a similar flour that did not contain amylase.Setting:Urban borough of Poto-Poto in Brazzaville, The Congo.Subjects:Eighty infants (40 in each group) were randomised into intervention and control groups. Three infants in the intervention group and two controls subsequently dropped out.Results:At 24 weeks, the addition of amylase resulted in a significant increase in energy intake (in kJ kg-1day-1) from gruels (P=0.02) without affecting breast milk consumption. In contrast, total energy intake (in kJ kg-1day-1) did not differ significantly between groups (P=0.08). After adjustment for morbidity and previous growth, infants in the intervention group showed better growth in length during the trial (+0.22 cm month-1;P=0.04), especially between 24 and 31 weeks of age (+0.51 cm month-1;P>0.01). There were no differences in weight velocity between groups.Conclusions:The findings of this study suggest that the consumption of amylase-treated gruels allows an increase in energy intake from these gruels without affecting breast milk consumption but has no impact on total daily energy intake. However, if started after 6 months, it could be effective in preventing faltering of infant linear growth.

scholarly journals Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yukari Isaka ◽  
Ai Hori ◽  
Rie Tanaka ◽  
Masao Ichikawa
Keyword(s):  
Cervical Cancer ◽  
Psychological Distress ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
And Control ◽  
Screening Result

Abstract Background The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. Methods The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. Results After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. Conclusions Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

2021 ◽  
pp. 026921552110411
Author(s):  
Hiromichi Takeda ◽  
Katsuhiko Takatori
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Adherence ◽  
Control Group ◽  
Adult Day Care ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control ◽  
Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

scholarly journals The Effectiveness of Online Course Intervention to Improve Knowledge of Antimicrobial Resistance among Dental Students, in Comparison to Reference Group Using a Randomized Controlled Trial

2019 ◽  
Vol 7 (17) ◽  
pp. 2917-2923
Author(s):  
Khalid T. Aboalshamat ◽  
Assim M. Banjar ◽  
Mahmoud I. Al-Jaber ◽  
Noor M. Turkistani ◽  
Mohammed T. Al-Amoudi
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Dental Students ◽  
Online Course ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
Significant Difference ◽  
Randomised Controlled ◽  
And Control

AIM: This study aimed to assess the effectiveness of a recognised antimicrobial resistance (AMR) online module on knowledge and perception among dental students, using a randomised controlled trial study design. METHODS: Dental students (n = 64, aged 21-25 years) in clinical years agreed to participate in this triple-blinded, parallel, randomised controlled trial. There were 34 students in the study group and 30 students in the control group. The study group participated in an online course covering information about AMR, while students in the control group received another online course about microorganisms in dentistry. Both groups were assessed three times using online questionnaires: before the intervention (T1), after the intervention (T2), and two months later (T3). Each one of T1, T2 and T3 had 22 questions. The questions were repeated each time in T1, T2, and T3 asking about AMR but with different question format, to avoid the possibility of students to memorise the answers. RESULTS: The mean (m) of correct answers for all students on T1 was 12.56, with standard deviation (SD) of 3.2. On T2, m = 14.03 and SD = 3.85, and on T3, m = 14.36 and SD = 3.71. Scores ranged from 0 to 22. The participants in the study and control groups showed significant score improvements from T1 to T2, immediately after the intervention, but there was no significant difference between T2 and T3. The study group students’ scores did not improve significantly from T1 to T3, in contrast to the control group students’ scores. More importantly, there was no significant difference in improvement from T1 to T2 when comparing the study and control groups. CONCLUSION: Online courses might not be reliable learning methods for ensuring the optimal levels of AMR knowledge that are needed by dental practitioners.

scholarly journals Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

2020 ◽  
Author(s):  
Yukari Isaka ◽  
Ai Hori ◽  
Rie Tanaka ◽  
Masao Ichikawa
Keyword(s):  
Cervical Cancer ◽  
Psychological Distress ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
And Control ◽  
Screening Result

Abstract Background: The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress.Methods: This study design was a simple randomized controlled trial that randomly assigned individual participants to the intervention and control groups and measured outcomes before and after the intervention. The analysis included 972 women. Women received hypothetical cervical cancer screening results, with a leaflet (intervention group) or without it (control group), randomly. Outcomes were psychological distress and intention to undergo further examination.Results: After the intervention, psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.Conclusions: Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer.Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

scholarly journals A co-designed mHealth programme to support healthy lifestyles in Māori and Pasifika peoples in New Zealand (OL@-OR@): a cluster-randomised controlled trial

2020 ◽  
Author(s):  
C Ni Mhurchu ◽  
Lisa Te Morenga ◽  
R Tupai-Firestone ◽  
J Grey ◽  
Y Jiang ◽  
...  
Keyword(s):  
New Zealand ◽  
Vegetable Intake ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Health Related ◽  
Randomised Controlled ◽  
And Control ◽  
Health Related Behaviour

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: The OL@-OR@ mobile health programme was co-designed with Māori and Pasifika communities in New Zealand, to support healthy lifestyle behaviours. We aimed to determine whether use of the programme improved adherence to health-related guidelines among Māori and Pasifika communities in New Zealand compared with a control group on a waiting list for the programme. Methods: The OL@-OR@ trial was a 12-week, two-arm, cluster-randomised controlled trial. A cluster was defined as any distinct location or setting in New Zealand where people with shared interests or contexts congregated, such as churches, sports clubs, and community groups. Members of a cluster were eligible to participate if they were aged 18 years or older, had regular access to a mobile device or computer, and had regular internet access. Clusters of Māori and of Pasifika (separately) were randomly assigned (1:1) to either the intervention or control condition. The intervention group received the OL@-OR@ mHealth programme (smartphone app and website). The control group received a control version of the app that only collected baseline and outcome data. The primary outcome was self-reported adherence to health-related guidelines, which were measured with a composite health behaviour score (of physical activity, smoking, alcohol intake, and fruit and vegetable intake) at 12 weeks. The secondary outcomes were self-reported adherence to health-related behaviour guidelines at 4 weeks; self-reported bodyweight at 12 weeks; and holistic health and wellbeing status at 12 weeks, in all enrolled individuals in eligible clusters; and user engagement with the app, in individuals allocated to the intervention. Adverse events were not collected. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12617001484336. Findings: Between Jan 24 and Aug 14, 2018, we enrolled 337 Māori participants from 19 clusters and 389 Pasifika participants from 18 clusters (n=726 participants) in the intervention group and 320 Māori participants from 15 clusters and 405 Pasifika participants from 17 clusters (n=725 participants) in the control group. Of these participants, 227 (67%) Māori participants and 347 (89%) Pasifika participants (n=574 participants) in the intervention group and 281 (88%) Māori participants and 369 (91%) Pasifika participants (n=650 participants) in the control group completed the 12-week follow-up and were included in the final analysis. Relative to baseline, adherence to health-related behaviour guidelines increased at 12 weeks in both groups (315 [43%] of 726 participants at baseline to 329 [57%] of 574 participants in the intervention group; 331 [46%] of 725 participants to 369 [57%] of 650 participants in the control group); however, there was no significant difference between intervention and control groups in adherence at 12 weeks (odds ratio [OR] 1·13; 95% CI 0·84–1·52; p=0·42). Furthermore, the proportion of participants adhering to guidelines on physical activity (351 [61%] of 574 intervention group participants vs 407 [63%] of 650 control group participants; OR 1·03, 95% CI 0·73–1·45; p=0·88), smoking (434 [76%] participants vs 501 [77%] participants; 1·12, 0·67–1·87; p=0·66), alcohol consumption (518 [90%] participants vs 596 [92%] participants; 0·73, 0·37–1·44; p=0·36), and fruit and vegetable intake (194 [34%] participants vs 196 [30%] participants; 1·08, 0·79–1·49; p=0·64) did not differ between groups. We found no significant differences between the intervention and control groups in any secondary outcome. 147 (26%) intervention group participants engaged with the OL@-OR@ programme (ie, set at least one behaviour change goal online). Interpretation: The OL@-OR@ mobile health programme did not improve adherence to health-related behaviour guidelines amongst Māori and Pasifika individuals. Funding: Healthier Lives He Oranga Hauora National Science Challenge.

scholarly journals The Effect of Interventional Program on Breastfeeding Self-Efficacy and Duration of Exclusive Breastfeeding in Pregnant Women in Ahvaz, Iran

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Somayeh Ansari ◽  
Parvin Abedi ◽  
Shirin Hasanpoor ◽  
Soheila Bani
Keyword(s):  
Pregnant Women ◽  
Exclusive Breastfeeding ◽  
Self Efficacy ◽  
Educational Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Breastfeeding Duration ◽  
Control Group ◽  
Control Groups ◽  
And Control

Objective. This study aimed to determine the effect of educational program on Breastfeeding self-efficacy and duration of exclusive breastfeeding in pregnant women in Ahvaz, Iran. Methods. This randomized controlled trial was conducted on 120 nulliparous pregnant women who tended to breastfeed. The primary self-efficacy scores of samples were measured using Faux and Dennis breastfeeding self-efficacy questionnaire. Women were randomly recruited into two intervention and control groups. Educational program (two training sessions, each lasted two hours) with two days interval was performed for intervention group. One month after delivery, self-efficacy scores were determined. Six months after child birth, duration of exclusive breastfeeding was assessed. Data were analyzed by means of descriptive and inferential statistics. Findings. The breastfeeding self-efficacy in the intervention group increased significantly compared to the control group one month after delivery (123.6 versus 101.7, P<0.001). The duration of exclusive breastfeeding was significantly higher in the intervention group (5.03 mo versus 2.7 mo, P<0.001). Also, there was a significant relationship between breastfeeding self-efficacy and duration of exclusive breastfeeding (P<0.001). Conclusion. The educational program could increase the self-efficacy and exclusive breastfeeding duration of mothers. These results can draw the attention of authorities to the importance of educational programs for mothers regarding the exclusive breastfeeding.

scholarly journals Did awarding badges increase data sharing in BMJ Open ? A randomized controlled trial

2020 ◽  
Vol 7 (3) ◽  
pp. 191818 ◽  
Author(s):  
Anisa Rowhani-Farid ◽  
Adrian Aldcroft ◽  
Adrian G. Barnett
Keyword(s):  
Randomized Controlled Trial ◽  
Data Sharing ◽  
Controlled Trial ◽  
Intervention Group ◽  
Open Data ◽  
Research Articles ◽  
Control Group ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control

Sharing data and code are important components of reproducible research. Data sharing in research is widely discussed in the literature; however, there are no well-established evidence-based incentives that reward data sharing, nor randomized studies that demonstrate the effectiveness of data sharing policies at increasing data sharing. A simple incentive, such as an Open Data Badge, might provide the change needed to increase data sharing in health and medical research. This study was a parallel group randomized controlled trial (protocol registration: doi:10.17605/OSF.IO/PXWZQ ) with two groups, control and intervention, with 80 research articles published in BMJ Open per group, with a total of 160 research articles. The intervention group received an email offer for an Open Data Badge if they shared their data along with their final publication and the control group received an email with no offer of a badge if they shared their data with their final publication. The primary outcome was the data sharing rate. Badges did not noticeably motivate researchers who published in BMJ Open to share their data; the odds of awarding badges were nearly equal in the intervention and control groups (odds ratio = 0.9, 95% CI [0.1, 9.0]). Data sharing rates were low in both groups, with just two datasets shared in each of the intervention and control groups. The global movement towards open science has made significant gains with the development of numerous data sharing policies and tools. What remains to be established is an effective incentive that motivates researchers to take up such tools to share their data.

scholarly journals The Effect of Preoperative Electronic Education on Anxiety of Patients Undergoing General Surgery

2021 ◽  
Vol In Press (In Press) ◽  
Author(s):  
Mohammad Rostami ◽  
Yahiya Salimi ◽  
Fereshteh Jalalvandi
Keyword(s):  
General Surgery ◽  
Controlled Trial ◽  
Intervention Group ◽  
Preoperative Anxiety ◽  
Surgical Patients ◽  
Control Group ◽  
Control Groups ◽  
Significant Difference ◽  
And Control ◽  
Electronic Education

Background: Preoperative anxiety is a common problem of surgical patients because it causes a range of emotional, psychological and physical problems. Numerous pharmacological and non-pharmacological methods have been used to reduce the level of anxiety in patients undergoing general surgery. Objectives: The aim of this study was to evaluate the effect of electronic education on preoperative anxiety in patients undergoing laparoscopic cholecystectomy (LC). Methods: The present study was a randomized controlled trial on 88 patients who were candidates for LC in two intervention and control groups in one of the Kermanshah hospitals. Patients in the intervention group received electronic education before surgery. The Visual Analog Scale Anxiety (VAS-A) questionnaire was used to measure anxiety before surgery in the study. Data analysis was performed using SPSS statistical software. Results: The results showed that there was no significant difference in the level of basic anxiety between the intervention and control groups. In second VAS-A evaluation, a significant mean difference was observed between the two groups so that the anxiety of the intervention group was calculated as 26.1 ± (SD = 16) vs. the control group as 45 ± (SD = 21). The mean of post-intervention anxiety compared to pre-intervention anxiety significantly decreased in the intervention group. Conclusions: Our findings highlight that electronic-based education can reduce the preoperative anxiety level in LC patients. Therefore, it's recommended to medical staff for delivering pre-surgery electronic educational interventions for LC surgical patients in order to reduce the level of preoperative anxiety.

scholarly journals Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

2020 ◽  
Author(s):  
Yukari Isaka ◽  
Ai Hori ◽  
Rie Tanaka ◽  
Masao Ichikawa
Keyword(s):  
Cervical Cancer ◽  
Psychological Distress ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
And Control ◽  
Screening Result

Abstract Background: The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial.Methods: The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups.Results: After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination.Conclusions: Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer.Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

scholarly journals Low adherence to exercise may have influenced the proportion of OMERACT-OARSI responders in an integrated OA care model: Secondary analyses from a cluster-randomised controlled trial

2019 ◽  
Author(s):  
Tuva Moseng ◽  
Hanne Dagfinrud ◽  
Leti van Bodegom-Vos ◽  
Krysia Dziedzic ◽  
Kåre Birger Hagen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Care Model ◽  
Structured Model ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
And Control

Abstract Background: To address the well-documented gap between hip and knee osteoarthritis (OA) treatment recommendations and current clinical practice, a structured model for integrated OA care was developed and evaluated in a stepped-wedge cluster-randomised controlled trial. The current study used secondary outcomes to evaluate clinically important response to treatment through the Outcome Measures in Rheumatology Clinical Trials clinical responder criteria (OMERACT-OARSI responder criteria) after 3 and 6 months between patients receiving the structured OA care model vs. usual care. Secondly, the study aimed to investigate if the proportion of responders in the intervention group was influenced by adherence to the exercise program inherent in the model. Methods: The study was conducted in primary healthcare in six Norwegian municipalities. General practitioners and physiotherapists received training in OA treatment recommendations and use of the structured model. The intervention group attended a physiotherapist-led OA education program and performed individually tailored exercises for 8-12 weeks. The control group received usual care. Patient-reported pain, function and global assessment of disease activity during the last week were evaluated using 11-point numeric rating scales (NRS 0-10). These scores were used to calculate the proportion of OMERACT-OARSI responders. Two-level mixed logistic regression models were fitted to investigate differences in responders between the intervention and control group. Results: 284 intervention and 109 control group participants with hip and knee OA recruited from primary care in six Norwegian municipalities. In total 47% of the intervention and 35% of the control group participants were responders at 3 or 6 months combined; showing an uncertain between-group difference (OR adjusted 1.38 (95% CI 0.41, 4.67). In the intervention group, 184 participants completed the exercise programme (exercised ≥2 times/week for ≥8 weeks) and 55% of these were classified as responders. In contrast, 28% of the 86 non-completers were classified as responders. Conclusions: The difference in proportion of OMERACT-OARSI responders at 3 and 6 months between the intervention and control group was uncertain. In the intervention group, a larger proportion of responders were seen among the exercise completers compared to the non-completers.

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