A Nutrition Education Intervention Using NOVA Is More Effective Than MyPlate Alone: A Proof-of-Concept Randomized Controlled Trial

The ability to classify foods based on level of processing, not only conventional MyPlate food groups, might be a useful tool for consumers faced with a wide array of highly processed food products of varying nutritional value. The objective of this study was to assess the impact of a proof-of-concept nutrition education intervention on nutrition knowledge, assessed by correct classification of foods according to MyPlate food groups, MyPlate ‘limit’ status (for fat, sugar, sodium), and level of processing (NOVA categories). We utilized a randomized, controlled design to examine the impact of a MyPlate vs. combined MyPlate + NOVA intervention vs. control group. Intervention groups received educational flyers via email and participants were assessed using electronic baseline and follow-up surveys. The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and ‘limit’ status. Moreover, the MyPlate + NOVA group far outperformed the other groups on classifying NOVA categories. Longer-term trials are needed, but our results suggest that NOVA principles may be more easily understood and applied than those of MyPlate. Education strategies focusing on level of food processing may be effective in the context of the modern food environment.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Effects of low glycemic index diet on insulin resistance among obese adolescent with non-alcoholic fatty liver disease: a randomized controlled trial

Medical Journal of Indonesia ◽

10.13181/mji.v28i2.2496 ◽

2019 ◽

Vol 28 (2) ◽

pp. 123-8 ◽

Cited By ~ 1

Author(s):

Agustini Utari ◽

Muhammad Saifulhaq Maududi ◽

Ninung Rose Diana Kusumawati ◽

Maria Mexitalia

Keyword(s):

Insulin Resistance ◽

Randomized Controlled Trial ◽

Liver Disease ◽

Nutrition Education ◽

Fatty Liver Disease ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Low Glycemic Index

BACKGROUND Obesity is strongly correlated with insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Some studies suggest that dietary intake with low glycemic index (GI) may prevent IR and reduce the incidences of NAFLD. This study was aimed to determine the effects of low GI diet on IR among obese adolescents with NAFLD. METHODS This study was a randomized controlled trial conducted in two JuniorHigh Schools in Semarang, Indonesia. The subjects were 12–14 years obese students with NAFLD, which divided into intervention and control groups according to schools using block random allocation. The intervention group received nutrition education and lunch diet (low energy, low GI, and low fat); meanwhile, the control group only received nutrition education for 12 weeks. The biochemical evaluation included fasting blood glucose (FBG) and insulin levels. IR was assessed using homeostatic model assessment-insulin resistance (HOMA-IR). RESULTS Thirty-two subjects were enrolled in this study, 16 of which were assigned to the intervention group and the other to the control group. After 12 weeks, the energy and carbohydrate intake reduced in the intervention group (p < 0.05), FBG remained unchanged, and HOMA-IR increased (4.9 [3.7]–7.2 [3.5]) compared to the control group (6.4 [4.9]–5.5 [2.8]) (p < 0.05). Meanwhile, within the control group, there were no significant differences in the energy and carbohydrate intake as well as biochemical variables. CONCLUSIONS Low GI modification diet alone may not reduce IR in the obeseadolescents with NAFLD.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering due to Physical Distancing: A Randomized Controlled Trial

10.20944/preprints202103.0097.v1 ◽

2021 ◽

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic some family physicians were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psycho-social support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW in-terventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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The Impact of Implementing Steps of Empowerment Model on Decisional Conflict for Re-Pregnancy for Women with Failed Pregnancies: A Randomized Controlled Trial

10.53350/pjmhs211551604 ◽

2021 ◽

Vol 15 (5) ◽

pp. 1604-1615

Author(s):

Mozhgan Zareyee Salehabadi ◽

Masoomeh Kheirkhah ◽

Nazanin Esmaeeli ◽

Shima Haghani

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Control Group ◽

Random Allocation ◽

Decision Conflict ◽

Randomized Controlled ◽

Empowerment Model ◽

The Impact

Background: Failed pregnancy is known as a common and destructive experience. It has physical and psychological effects on both women and their families. Due to this experience, they may become reluctant to be pregnant again. In this regard, providing the coping strategies can help in being adapted to failed pregnancies, and making informed decisions on future pregnancies. So, this study was designed and then performed to determine the effect of implementing steps of empowerment model on decision conflict for re-pregnancy for women with failed pregnancies Method: This interventional research was a randomized controlled trial with a control group conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during the past 3-6 weeks due to failed pregnancies. Afterward, the eligible women were divided into the two groups of intervention (n=40) and control (n=40) with random allocation of sealed envelope site and a separate code was then determined for each person. The intervention was performed in four sessions lasted for 90-minute based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed in both groups once before and once six weeks after intervention. The obtained data were analyzed using SPSS edition 16 with the independent T-test, Fisher, and chi-squared tests. Results The scores of decisional conflict and its subscales had no differences between the two groups before the intervention (P = 0.65). However, by passing six weeks from the intervention, the decisional conflict and all its subscales have reduced in the intervention group. (P < 0.001). Conclusion: Empowerment education in women with failed pregnancies improved their decision conflict in immune re-pregnancy, so empowerment education along with health care services is recommended for women with failed pregnancies. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019. https://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=5336 Keywords: Empowerment, Conflict, Decision Making, Failed Pregnancy.

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Nutrition information system (SISFORNUTRIMIL) application With Online Food Record for Indonesia Pregnant Women: Protocol for Randomized Controlled Trial

10.21203/rs.3.rs-634069/v1 ◽

2021 ◽

Author(s):

Mira Trisyani Koeryaman ◽

Saseendran Pallikadavath ◽

Isobel Ryder ◽

Ngianga Kandala

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Dietary Diversity ◽

Controlled Trial ◽

Intervention Group ◽

Eating Behaviour ◽

Control Group ◽

Food Record ◽

Randomized Controlled ◽

The Impact

Abstract Background: The pregnant women and family may not have the necessary knowledge and skills to estimate nutrient value in food in line with dietary targets and the guidelines, i.e. they do not know whether or not they are consuming the right amount of nutrition needed during pregnancy. The aims of this randomized controlled trial (RCT) is to examine the impact of SISFORNUTRIMIL application on maternal eating behaviour and associated maternal factors such as weight gain, blood pressure, biochemical measurement, and pregnancy outcome.Methods: The study recruits 112 participants with eligible criteria during December 2019 to January 2020. The allocation of participants is 1:1 to the SISFORNUTRIMIL application user and non-user application, with criteria: singleton pregnancy (22-26 weeks), mother age between 20-35 years), have monthly income and literate. Both groups will receive 12-week standard health services from health professionals and received information about dietary diversity and food record. Particularly, intervention group could be access the SISFORNUTRIMIL on their devices, which provide necessary information about nutrition in pregnancy, food record and food choice includes total serving size calculation. In contrast, the control group only receive food information and food intake record by paper-based, and they should record and calculate the nutrition intake by traditionally. Discussion: This is the first randomized controlled trial to examine the SISFORNUTIMIL application. This mandate reflects keen interest and motivation for the proposed research study. This is in addition to the researcher’s personal efforts to reduce morbidity and mortality rate as well as a general focus on pregnancy complication prevention than nutrition treatment. Thus, an investigation of eating behaviour and associated maternal needed to address this issue. Firstly, the results could extend the scope of knowledge about nutrition intervention to include the Indonesia pregnant women context as well as the Indonesia health ministry context. Secondly, this research could help to change individual health behaviour and activity undertaken by an individual who believes her-self to be healthy.Trial registration: ISRCTN Registry: ISRCTN42690828. Date of registration: 22 October 2019.

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REPRINTED WITH PERMISSION OF IASP - PAIN 158 (2017) 868–878: A tailored-guided internet-based cognitive-behavioral intervention for patients with rheumatoid arthritis as an adjunct to standard rheumatological care: results of a randomized controlled trial

Ból ◽

10.5604/01.3001.0012.0656 ◽

2017 ◽

Vol 18 (4) ◽

pp. 20-34

Author(s):

Maaike Ferwerda ◽

Sylvia van Beugen ◽

Henriët van Middendorp ◽

Saskia Spillekom-van Koulil ◽

A. Rogier T. Donders ◽

...

Keyword(s):

Physical Functioning ◽

Psychological Functioning ◽

Daily Life ◽

Controlled Trial ◽

Intervention Group ◽

Cognitive Behavioral ◽

Control Group ◽

Cognitive Behavioral Intervention ◽

Randomized Controlled ◽

The Impact

For patients with chronic pain conditions such as rheumatoid arthritis (RA), who experience elevated levels of distress, tailored guided internet-based cognitive-behavioral treatment may be effective in improving psychological and physical functioning, and reducing the impact of RA on daily life. A multicenter, randomized controlled trial was conducted for RA patients with elevated levels of distress as assessed by a disease-specific measure. The control group (n=71) received standard care and the intervention group (n = 62) additionally received an internet-based tailored cognitive-behavioral intervention. Main analyses were performed using a linear mixed model estimating differences between the intervention and control groups in scores of psychological functioning, physical functioning, and impact of RA on daily life at preassesment and postassessment, and at 3, 6, 9, and 12 months. Patients who received the internet-based intervention reported a larger improvement in psychological functioning compared with the control group, indicating less depressed mood (P < 0.001, d = 0.54), negative mood (P = 0.01, d = 0.38), and anxiety (P < 0.001, d = 0.48) during the course of the 1-year follow-up period. Regarding physical functioning, a trend was found for the intervention group reporting less fatigue than the control group (P = 0.06, d= 0.24), whereas no effect was found on pain. No effects were found for the impact of RA on daily life, except for the intervention group experiencing fewer role limitations due to emotional problems (P < 0.001, d = 0.53). Offering guided internet-based cognitive-behavioral therapy is a promising development to aid patients with psychological distress particularly in improving psychological functioning. Further research on adherence and specific intervention ingredients is warranted.

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Universal Screening and Decolonization for Control of MRSA in Nursing Homes: A Cluster Randomized Controlled Study

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2014.74 ◽

2015 ◽

Vol 36 (4) ◽

pp. 401-408 ◽

Cited By ~ 13

Author(s):

Cristina Bellini ◽

Christiane Petignat ◽

Eric Masserey ◽

Christophe Büla ◽

Bernard Burnand ◽

...

Keyword(s):

Universal Screening ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Standard Precautions ◽

Carriage Rate ◽

Randomized Controlled ◽

Cluster Randomized ◽

The Impact

OBJECTIVEThe risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs.DESIGNCluster randomized controlled trialSETTINGNHs of the state of Vaud, SwitzerlandPARTICIPANTSOf 157 total NHs in Vaud, 104 (67%) participated in the study.INTERVENTIONStandard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers.RESULTSNHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%–100%) in control NHs and 87% (20%–100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%–43%) and intervention NHs (range, 0%–38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66).CONCLUSIONUniversal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.Infect Control Hosp Epidemiol 2015;00(0): 1–8

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Improving surgical patient’s knowledge about safe use of opioids: A Randomized Controlled Trial

10.21203/rs.3.rs-41224/v1 ◽

2020 ◽

Author(s):

Helen R Doherty ◽

Enoch Lam ◽

Maria Garstka ◽

Junior Chuang ◽

David Tai Wong ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Knowledge Score ◽

Controlled Study ◽

Control Group ◽

Routine Practice ◽

Opioid Use ◽

Randomized Controlled ◽

The Difference ◽

The Impact

Abstract Background Currently, it is not routine practice to provide standardized patient education for safe postoperative opioid use. The objective of our study was to evaluate the impact of an educational pamphlet for surgical patients on knowledge about safe use, proper storage, and disposal of opioids.Methods This multi-center randomized controlled study recruited 100 patients in the pre-operative clinic. Inclusion criteria were English-speaking, ≥ 18 years, able to give informed consent, and not on opioids for chronic pain or within the past 30 days. All patients completed a baseline knowledge questionnaire (maximum score 38) on opioid safety. Patients were randomized to intervention: educational pamphlet, or control: standard care (no pamphlet) group. Questionnaires were repeated immediately post-education in the intervention group, and at 15, and 30 days after surgery in both groups. The primary outcome was change in knowledge score post-education in the intervention compared to control group. Secondary outcomes were immediate post-education, 15, and 30-day score, and answering safe storage, and disposal questions correctly.Results Between groups, the post-education score immediately after the intervention was higher in the intervention vs. control group baseline 34.2 [95% CI 33.1–35.3] vs 28.3 [95% CI 26.6–29.9]; P < 0.0001). In the intervention vs control group, mean scores were higher 31.6 (95% CI 30.5–32.7) vs 29.1 (95% CI 27.9–30.2; P = .002) at 15 days, and 32.4 (95%CI 31.4–33.5) vs 30.5 (95% CI 29.2–31.7; P = .017) at 30 days. Within the intervention group, the mean score immediately post-education (34.2 [95% confidence interval (CI) 33.1–35.3]) was higher than baseline (27.8 [95% CI 26.3–29.3]); P < 0.0001. Within the intervention group, the difference in mean score versus baseline was 3.8 (95% CI 2.1–5.5) at 15 days, and 4.6 (95% CI 2.9–6.3) at 30 days, (P < 0.05 for all timepoints). For safe disposal, a correct answer was given (intervention vs control group) by 100% vs 89.7% at 30 days (P = 0.04).Conclusions Within the intervention group, there was a significant improvement in knowledge on safe opioid use immediately post-education, and retention of knowledge at 15 and 30 days postoperatively. The intervention group had better knowledge scores compared to the baseline control group, and 15 and 30 days after surgery.Trial Registration: This study was registered in clinicaltrials.gov: NCT03959787 on May 22, 2019.

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The Impact of Implementing Steps of Empowerment Model for Women with Failed Pregnancies on Decisional Conflict for Re-pregnancy: A Randomized Controlled Trial

10.21203/rs.3.rs-34460/v1 ◽

2020 ◽

Author(s):

Masoomeh Kheirkhah ◽

Mozhgan Zareyee Salehabadi ◽

Nazanin Esmaeeli ◽

Shima Haghani

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Decisional Conflict ◽

Control Group ◽

Random Allocation ◽

Decision Conflict ◽

Randomized Controlled ◽

Empowerment Model ◽

The Impact

Abstract Background: Failed pregnancy is a common and destructive experience. It has physical and psychological effects on both women and families. They may become reluctant to re-pregnancy. Providing the coping strategies can help to adapt to failed pregnancies, and make informed decisions about future pregnancies. This study was designed and performed to determine the effect of implementing steps of empowerment model for women with failed pregnancies on decision conflict for re-pregnancy. Method: This interventional research is a randomized controlled trial with a control group that was conducted in Iran from January 2020 to May 2020. Participants were 80 women who had been hospitalized in a referral center during past 3-6 weeks due to failed pregnancies. The eligible women with random allocation of sealed envelope site were divided into two groups of intervention (n=40) and control (n=40) and a separate code was determined for each person. The intervention was performed in four, 90-minute sessions based on the model steps (threat perception, problem solving, educational participation, and evaluation) for intervention group. O'Connor's decisional conflict scale was completed before and six weeks after intervention by both of groups. Data were analyzed using SPSS edition 16 with the independent T-test, Fisher and chi-squared tests. Results: The score of decisional conflict and, its subscales did not differ between the two groups before the intervention (P = 0.65), but six weeks after the intervention, the decisional conflict and, all its subscales in the intervention group reduced. (P < 0.001).Conclusion: Empowerment education in women with a failed pregnancy improved their decision conflict in re-pregnancy, so empowerment education along with health care services for women with failed pregnancies is recommended. Trial registration: This randomized control trial was registered on the TCTR site with the code TCTR20191226001. Registered on 26 December 2019.

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