Can the supplementary consumption of baobab (Adansonia digitata L.) fruit pulp improve the hemoglobin levels and iron status of schoolchildren in Kenya? Findings of a randomized controlled intervention trial

Abstract Purpose In the rural Kenyan diet, the bioavailability of iron is low and predisposes the population to iron deficiency. Fruit pulp of the indigenous baobab tree contains significant amounts of vitamin C, which enhances non-heme iron bioavailability. We studied the impact of baobab fruit pulp (BFP) consumption on the hemoglobin (Hb) and iron status of Kenyan schoolchildren. Methods The single-blind randomized controlled intervention trial was implemented daily among apparently healthy schoolchildren aged 6–12 years with hemoglobin level < 12.2 g/dl. For 12 weeks, children in the intervention group (n = 29) received a drink with BFP, while the control group (n = 29) received an isoenergy drink without BFP. At baseline and endline, blood samples were taken. Results The development of hemoglobin, ferritin (FER) and soluble transferrin receptor (sTfR) did not differ significantly between the intervention and control groups. However, in the intervention group, Hb levels improved slightly (2.2%), while they decreased slightly (1.2%) in the control group. Levels of geometric means of sTfR remained almost unchanged (0.7%) in the intervention group and slightly worsened (2.7%) in the control group. In both the groups, geometric mean of FER levels decreased, yet to a smaller extent in the intervention (17.3%) than in the control (26.0%) group. Conclusion Even though no significant effects of BFP could be detected in this study, the identification of products such as BFP remains pertinent to help improve non-heme iron absorption in the most vulnerable populations.

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

Nutrients ◽

10.3390/nu11122965 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2965

Author(s):

Aydin Nazmi ◽

Marilyn Tseng ◽

Derrick Robinson ◽

Dawn Neill ◽

John Walker

Keyword(s):

Nutrition Education ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Education Intervention ◽

Proof Of Concept ◽

Food Groups ◽

Randomized Controlled ◽

The Impact ◽

Level Of Processing

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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Impact of an Antimicrobial Utilization Program on Antimicrobial Use at a Large Teaching Hospital A Randomized Controlled Trial

Infection Control and Hospital Epidemiology ◽

10.1086/605924 ◽

2009 ◽

Vol 30 (10) ◽

pp. 931-938 ◽

Cited By ~ 81

Author(s):

Bernard C. Camins ◽

Mark D. King ◽

Jane B. Wells ◽

Heidi L. Googe ◽

Manish Patel ◽

...

Keyword(s):

Internal Medicine ◽

Teaching Hospital ◽

Antimicrobial Agents ◽

Intervention Group ◽

Control Group ◽

Antimicrobial Use ◽

Randomized Controlled ◽

Antimicrobial Usage ◽

Antimicrobial Utilization ◽

The Impact

Background.Multidisciplinary antimicrobial utilization teams (AUTs) have been proposed as a mechanism for improving antimicrobial use, but data on their efficacy remain limited.Objective.To determine the impact of an AUT on antimicrobial use at a teaching hospital.Design.Randomized controlled intervention trial.Setting.A 953-bed, public, university-affiliated, urban teaching hospital.Patients.Patients who were given selected antimicrobial agents (piperacillin-tazobactam, levofloxacin, or vancomycin) by internal medicine ward teams.Intervention.Twelve internal medicine teams were randomly assigned monthly: 6 teams to an intervention group (academic detailing by the AUT) and 6 teams to a control group that was given indication-based guidelines for prescription of broad-spectrum antimicrobials (standard of care), during a 10-month study period.Measurements.Proportion of appropriate empirical, definitive (therapeutic), and end (overall) antimicrobial usage.Results.A total of 784 new prescriptions of piperacillin-tazobactam, levofloxacin, and vancomycin were reviewed. The proportion of antimicrobial prescriptions written by the intervention teams that was considered to be appropriate was significantly higher than the proportion of antimicrobial prescriptions written by the control teams that was considered to be appropriate: 82% versus 73% for empirical (risk ratio [RR], 1.14; 95% confidence interval [CI], 1.04-1.24), 82% versus 43% for definitive (RR, 1.89; 95% CI, 1.53-2.33), and 94% versus 70% for end antimicrobial usage (RR, 1.34; 95% CI, 1.25-1.43). In multivariate analysis, teams that received feedback from the AUT alone (adjusted RR, 1.37; 95% CI, 1.27-1.48) or from both the AUT and the infectious diseases consultation service (adjusted RR, 2.28; 95% CI, 1.64-3.19) were significantiy more likely to prescribe end antimicrobial usage appropriately, compared with control teams.Conclusions.A multidisciplinary AUT that provides feedback to prescribing physicians was an effective method in improving antimicrobial use.Trial Registration.ClinicalTrials.gov identifier: NCT00552838.

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PHARMACEUTICAL CARE OF ADOLESCENTS WITH DIABETES MELLITUS TYPE 1: THE DIADEMA STUDY, A RANDOMIZED CONTROLLED TRIAL

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-310148.7 ◽

2015 ◽

Vol 101 (1) ◽

pp. e1.67-e1

Author(s):

Emina Obarčanin ◽

Manfred Krueger ◽

Petra Mueller ◽

Verena Nemitz ◽

Holger Schwender ◽

...

Keyword(s):

Diabetes Mellitus ◽

Pharmaceutical Care ◽

Intervention Group ◽

Well Being ◽

Diabetes Mellitus Type ◽

Control Group ◽

Randomized Controlled ◽

Phone Calls ◽

The Impact

BackgroundAdolescents with type 1 diabetes mellitus (T1DM) often show low adherence to complex insulin regimens, leading to poor glycemic control. The benefit of pharmaceutical care in adults with diabetes mellitus type 2 (T2DM) has been widely explored; however, evidence in adolescents with T1DM remains scarce.ObjectiveTo evaluate the impact of pharmaceutical care in adolescents with T1DM provided by a multidisciplinary team on multiple important clinical outcomes.SettingAt the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one pharmacist on-site in Sarajevo, Bosnia-Herzegovina.MethodsA randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care delivered by pharmacists plus supplementary phone calls for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. In addition, HbA1c was measured after 12 months.Main outcome measures The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c), the number of severe hypoglycemic events in both groups, and patient well-being in the intervention group.ResultsThe improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline −0.54 vs. +0.32%, p=0.0075), even after adjustment for country-specific variables (p=0.0078). However, the effect was more pronounced after only 3 months (−1.09 vs. +0.23%, p=0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. After 6 months, the well-being according to the WHO-5 index in the intervention group increased significantly from 52.8% to 63.3%. After 12 months the mean total HbA1c remained significantly reduced in the intervention compared to the control group (8.6% vs. 9.5%, p=0.0184).ConclusionThe improved outcomes seen in this study provide new evidence that pharmaceutical care adds value to the management of T1DM in adolescents. However, the optimal methods of achieving sustained long-term improvements in this specific patient population require further study.

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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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The impact of medication reviews conducted in primary care on hospital admissions and mortality - a randomized controlled trial

10.21203/rs.2.11674/v1 ◽

2019 ◽

Author(s):

Veronica Milos Nymberg ◽

Cecilia Lenander ◽

Beata Borgström Bolmsjö

Keyword(s):

Primary Care ◽

Elderly Patients ◽

Usual Care ◽

Frail Elderly ◽

Hospital Admissions ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Medication Reviews ◽

The Impact

Abstract Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs’ on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months. Results Of the total number of 369 included patients, 182 were randomized to the intervention group and 187 to the control group. Most of the patients (75%) were females and lived in nursing homes. At six months, 50 patients of the baseline population (27%) in the control group had been admitted to hospital at least once, compared to 40 patients (21%) in the intervention group. At 12 months, the percentage had increased to 70 (37%) in the control group compared to 53 (29%) in the intervention group. Compared to usual care, we found that MRs reduced the risk of hospital admissions within 12 months by 36% (HR = 0.64, 95% CI 0.45-0.90), but found no difference on mortality (HR = 1.12, 95% CI 0.78-1.61) between the groups. Conclusion We suggest that MRs should be recommended in the care of frail elderly patients with expected benefits on hospital admissions.

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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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