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Impact and process evaluation of a primary-school Food Education and Sustainability Training (FEAST) program in 10-12-year-old children in Australia: pragmatic cluster non-randomized controlled trial.
Karpouzis, F, Lindberg, R, Walsh, A, Shah, S, Abbott, G, Ball, K
BMC public health. 2024;(1):657
Abstract
BACKGROUND Environmentally sustainable food initiatives accompanying nutrition education, such as the Food Education and Sustainability Training (FEAST) program, have gained traction in school settings. The aim of this trial was to conduct an impact and process evaluation of FEAST, to evaluate its effect on children's fruit and vegetable (F&V) intakes, and secondary outcomes: F&V variety consumed, nutrition knowledge, food preparation/cooking skills, self-efficacy and behaviours, food waste knowledge and behaviours, and food production knowledge. METHODS FEAST was a 10-week curriculum-aligned program, designed to educate children about healthy eating, food waste, and sustainability, while teaching cooking skills. It was implemented by classroom teachers, face-to-face and online, during COVID-19 school closures, in Australia in 2021. A custom designed survey was used to collect baseline and post-intervention data from students. Generalised linear mixed models (GLMM) estimated group differences in pre-post changes for primary and secondary outcomes. Surveys were also administered to students and teachers to evaluate intervention implementation. RESULTS Twenty schools participated and self-selected to be either intervention schools (n = 10) or wait-list control (WLC) schools (n = 10). A total of 977, 5th and 6th grade children participated in the trial with a mean age of 11.1 years (SD ± 0.7). The FEAST intervention, compared to WLC, did not result in significant increases in primary outcomes nor secondary outcomes. The process evaluation revealed FEAST was well-received by students and teachers, but COVID-19 school closures hindered implementation fidelity with a less intense program delivered under the constraints of pandemic lockdowns. CONCLUSIONS This is the first cluster non-randomized controlled trial designed to independently evaluate FEAST in the primary-school setting. No evidence was found for improved F&V intakes in children, nor secondary outcomes. However, the positive process evaluation results suggest that further trials of the program are warranted. If implemented as originally designed (pre-pandemic), with increased duration and complemented by supporting school policies, such programs have the potential to improve children's daily F&V intakes, cooking skills and food waste behaviours. This would support the Australian curriculum and contribute to: health promotion within schools and sustainable schools initiatives, the national agenda to reduce food waste and sustainable development goals. AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY [ACTRN12620001347954]- Registered prospectively on 14/12/2020.
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Effects of a family-based lifestyle intervention on co-physical activity and other health-related outcomes of fathers and their children: the 'Run Daddy Run' intervention.
Latomme, J, Morgan, PJ, Chastin, S, Brondeel, R, Cardon, G
BMC public health. 2023;(1):342
Abstract
BACKGROUND Fathers are important in establishing healthy behaviors in their children, but are rarely engaged in lifestyle programs. Focusing on physical activity (PA) of both fathers and their children by engaging them together in PA (i.e. "co-PA") is therefore a promising novel strategy for interventions. The study aim was to investigate the effect of the 'Run Daddy Run' on co-PA and PA of fathers and their children, and secondary outcomes such as weight status and sedentary behaviour (SB). METHODS This study is a non-randomized controlled trial (nRCT), including 98 fathers and one of their 6 to 8 years old children (intervention = 35, control = 63). The intervention was implemented over a 14-week period, and consisted of six (inter)active father-child sessions and an online component. Due to COVID-19, only 2/6 sessions could be implemented as planned, the remaining sessions were delivered online. In November 2019-January 2020 pre-test measurements took place, and post-test measurements in June 2020. Additional follow-up test was conducted in November 2020. PA (i.e. LPA, MPA, VPA and volume) of fathers and children were objectively measured using accelerometry, co-PA and the secondary outcomes were questioned using an online questionnaire. RESULTS Significant intervention effects were found for co-PA (+ 24 min./day in the intervention compared to the control group, p = 0.002), and MPA of the father (+ 17 min./day, p = 0.035). For children, a significant increase in LPA (+ 35 min./day, p < 0.001) was found. However, an inverse intervention effect was found for their MPA and VPA (-15 min./day, p = 0.005 and - 4 min./day, p = 0.002, respectively). Also decreases in fathers' and children's SB were found (-39 min./day, p = 0.022 and - 40 min./day, p = 0.003, respectively), but no changes in weight status, the father-child relationship, and the PA-family health climate (all p > 0.05). CONCLUSION The Run Daddy Run intervention was able to improve co-PA, MPA of fathers and LPA of children, and decreasing their SB. Inverse intervention effects were however found for MPA and VPA of children. These results are unique given their magnitude and clinical relevance. Targeting fathers together with their children might be a novel and potential intervention strategy to improve overall physical activity levels, however, further efforts should however be made to target children's MPA and VPA. Last, replicating these findings in a randomized controlled trial (RCT) is recommended for future research. TRIAL REGISTRATION NUMBER This study is registered as a clinical trial (clinicaltrials.gov, ID number: NCT04590755, date: 19/10/2020).
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Can the supplementation of vitamin D, sun exposure, and isolation during the COVID-19 pandemic affect the seasonal concentration of 25(OH)D and selected blood parameters among young soccer players in a one-year training season?
Jastrzębska, J, Skalska, M, Radzimiński, Ł, López Sánchez, GF, Hill, L, Weiss, K, Knechtle, B
Journal of the International Society of Sports Nutrition. 2023;(1):2206802
Abstract
OBJECTIVE This study examined the effect of vitamin D supplementation, sunlight radiationradiation, and home isolation during the COVID-19 pandemic on the seasonal changes in 25(OH)D concentration and selected biomarkers in young soccer players along a one-year training cycle. METHOD Forty elite young soccer players (age: 17.2 ± 1.16 years, body mass: 70.2 ± 5.84, and body height: 179.1 ± 4.26 cm) participated in the research. Only 24 players completed the measurements during all four time- points (T1-: September 2019, T2-: December 2019, T3-: May 2020, and T4-: August 2020) and were divided into two subgroups: supplemented group (GS) and placebo group (GP). Players from GS received 5,000 IU of vitamin D for 8 weeks (January-MarchJanuary-March 2020). Several biomarkers such as 25(OH)D, white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), muscle damage markersmarkers, and lipid profile were measured. RESULTS AnalysisThe analysis of the total group demonstrated significant seasonal changes in 25(OH)D, HGB, asparagine aminotransferaseaminotransferase, and creatine kinase along the one1-year training cycle. The level of 25(OH)D concentrationinconcentration in T4 was significantly (p < 0.001, pη [ = 0.82) higher in both subgroups in comparison to T2 and T3. Moreover, the significant (p = 0.023) but poor (r = -0.23) correlation between 25(OH)D and WBC was calculated. CONCLUSION Current research confirmed the significant seasonal changes in 25(OH)D concentration during four seasons. 8-weekEight-week vitamin D supplementation had no extended effect on the level of 25(OH)D concentration.
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Utilisation of ANC services before and after the COVID-19 pandemic in selected resource-poor blocks of India: role of community health workers in Swabhimaan programme area.
Dhillon, P, Unisa, S, Gupta, A, Saraswat, A, Km, S, Pedgaonkar, S
BMC health services research. 2023;(1):864
Abstract
INTRODUCTION COVID-19 has disrupted maternal and child health services. Community Health Workers (CHWs) supported the women by visiting pregnant women's homes and providing the MCH services as required. This study attempts to understand the role of CHW and its impact on the Ante-Natal Care (ANC) services pre-pandemic and post-Pandemic in the poor resource setting. METHODS The Swabhimaan programme interventions were carried out in the selected blocks in the Indian States of Bihar, Odisha and Chhattisgarh with the objective to improve the nutritional status of mothers, pregnant women and adolescents living in resource-poor blocks of three selected states during 2016-2022. Cross-sectional surveys, namely pre-pandemic (2018-19) and post-pandemic (2021-22) of pregnant and mothers of under two children, utilised to fulfil the objectives of this study. These surveys are part of Swabhimaan evaluation, a community-based non-randomised controlled study. RESULTS The ANC services received by women have increased over time from 2015 to 2022. Our findings confirm that the ground-level community and health systems were active during the pandemic, and the results show significant improvement. Additionally, the women supported by the CHW have substantially improved pregnancy registration, first ANC, Tetanus injection, consumption of Iron Folic Acid, Calcium and deworming tablets than those who did not. Propesnsity Score Matching analysis shows that the average treatment effect on the various ANC services of having the support of CHW is significant. CONCLUSION This study shows the vital role of CHWs in utilising various Maternal and Child Health services. Better linkage and networking of the CHWs with the community will ensure health service delivery regularly and in an emergency like a pandemic and develop resilience.
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Oxaloacetate Treatment For Mental And Physical Fatigue In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Long-COVID fatigue patients: a non-randomized controlled clinical trial.
Cash, A, Kaufman, DL
Journal of translational medicine. 2022;(1):295
Abstract
BACKGROUND There is no approved pharmaceutical intervention for Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS). Fatigue in these patients can last for decades. Long COVID may continue to ME/CFS, and currently, it is estimated that up to 20 million Americans have significant symptoms after COVID, and the most common symptom is fatigue. Anhydrous Enol-Oxaloacetate, (AEO) a nutritional supplement, has been anecdotally reported to relieve physical and mental fatigue and is dimished in ME/CFS patients. Here, we examine the use of higher dosage AEO as a medical food to relieve pathological fatigue. METHODS ME/CFS and Long-COVID patients were enrolled in an open label dose escalating "Proof of Concept" non-randomized controlled clinical trial with 500 mg AEO capsules. Control was provided by a historical ME/CFS fatigue trial and supporting meta-analysis study, which showed average improvement with oral placebo using the Chalder Scale of 5.9% improvement from baseline. At baseline, 73.7% of the ME/CFS patients were women, average age was 47 and length of ME/CFS from diagnosis was 8.9 years. The Long-COVID patients were a random group that responded to social media advertising (Face Book) with symptoms for at least 6 months. ME/CFS patients were given separate doses of 500 mg BID (N = 23), 1,000 mg BID (N = 29) and 1000 mg TID (N = 24) AEO for six weeks. Long COVID patients were given 500 mg AEO BID (N = 22) and 1000 mg AEO (N = 21), again over a six-week period. The main outcome measure was to compare baseline scoring with results at 6 weeks with the Chalder Fatigue Score (Likert Scoring) versus historical placebo. The hypothesis being tested was formulated prior to data collection. RESULTS 76 ME/CFS patients (73.7% women, median age of 47) showed an average reduction in fatigue at 6 weeks as measured by the "Chalder Fatigue Questionnaire" of 22.5% to 27.9% from baseline (P < 0.005) (Likert scoring). Both physical and mental fatigue were significantly improved over baseline and historical placebo. Fatigue amelioration in ME/CFS patients increased in a dose dependent manner from 21.7% for 500 mg BID to 27.6% for 1000 mg Oxaloacetate BID to 33.3% for 1000 mg TID. Long COVID patients' fatigue was significantly reduced by up to 46.8% in 6-weeks. CONCLUSIONS Significant reductions in physical and metal fatigue for ME/CFS and Long-COVID patients were seen after 6 weeks of treatment. As there has been little progress in providing fatigue relief for the millions of ME/CFS and Long COVID patients, anhydrous enol oxaloacetate may bridge this important medical need. Further study of oxaloacetate supplementation for the treatment of ME/CFS and Long COVID is warranted. Trial Registration https://clinicaltrials.gov/ct2/show/NCT04592354 Registered October 19, 2020. 1,000 mg BID Normalized Fatigue Data for Baseline, 2-weeks and 6-weeks evaluated by 3 Validated Fatigue Scoring Questionnaires.
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20-Week Study of Clinical Outcomes of Over-the-Counter COVID-19 Prophylaxis and Treatment.
Margolin, L, Luchins, J, Margolin, D, Margolin, M, Lefkowitz, S
Journal of evidence-based integrative medicine. 2021;:2515690X211026193
Abstract
OBJECTIVES AND SETTING.: As the lethal COVID-19 pandemic enters its second year, the need for effective modalities of alleviation remains urgent. This includes modalities that can readily be used by the public to reduce disease spread and severity. Such preventive measures and early-stage treatments may temper the immediacy of demand for advanced anti-COVID measures (drugs, antibodies, vaccines) and help relieve strain also on other health system resources. DESIGN AND PARTICIPANTS.: We present results of a clinical study with a multi-component OTC "core formulation" regimen used in a multiply exposed adult population. Analysis of clinical outcome data from our sample of over 100 subjects - comprised of roughly equal sized regimen-compliant (test) and non-compliant (control) groups meeting equivalent inclusion criteria - demonstrates a strong statistical significance in favor of use of the core formulations. RESULTS.: While both groups were moderate in size, the difference between them in outcomes over the 20-week study period was large and stark: Just under 4% of the compliant test group presented flu-like symptoms, but none of the test group was COVID-positive; whereas 20% of the non-compliant control group presented flu-like symptoms, three-quarters of whom (15% overall of the control group) were COVID-positive. CONCLUSIONS.: Offering a low cost, readily implemented anti-viral approach, the study regimen may serve, at the least, as a stopgap modality and, perhaps, as a useful tool in combatting the pandemic.
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Effects of antiviral drug therapy on dynamic thiol/disulphide homeostasis and nitric oxide levels in COVID-19 patients.
Mete, AÖ, Koçak, K, Saracaloglu, A, Demiryürek, S, Altınbaş, Ö, Demiryürek, AT
European journal of pharmacology. 2021;:174306
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Abstract
The novel coronavirus disease 2019 (COVID-19) has led to a serious global pandemic. Although an oxidative stress imbalance occurs in COVID-19 patients, the contributions of thiol/disulphide homeostasis and nitric oxide (NO) generation to the pathogenesis of COVID-19 have been poorly identified. Therefore, the aim of this study was to evaluate the effects of antiviral drug therapy on the serum dynamics of thiol/disulphide homeostasis and NO levels in COVID-19 patients. A total of 50 adult patients with COVID-19 and 43 sex-matched healthy control subjects were enrolled in this prospective study. Venous blood samples were collected immediately on admission to the hospital within 24 h after the diagnosis (pre-treatment) and at the 15th day of drug therapy (post-treatment). Serum native thiol and total thiol levels were measured, and the amounts of dynamic disulphide bonds and related ratios were calculated. The average pre-treatment total and native thiol levels were significantly lower than the post-treatment values (P < 0.001 for all). We observed no significant changes in disulphide levels or disulphide/total thiol, disulphide/native thiol, or native thiol/total thiol ratios between pre- and post-treatments. There was also a significant increase in serum NO levels in the pre-treatment values when compared to control (P < 0.001) and post-treatment measurements (P < 0.01). Our results strongly suggest that thiol/disulphide homeostasis and nitrosative stress can contribute to the pathogenesis of COVID-19. This study was the first to show that antiviral drug therapy can prevent the depletion in serum thiol levels and decrease serum NO levels in COVID-19 patients.
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Effect of a combination of nitazoxanide, ribavirin, and ivermectin plus zinc supplement (MANS.NRIZ study) on the clearance of mild COVID-19.
Elalfy, H, Besheer, T, El-Mesery, A, El-Gilany, AH, Soliman, MA, Alhawarey, A, Alegezy, M, Elhadidy, T, Hewidy, AA, Zaghloul, H, et al
Journal of medical virology. 2021;(5):3176-3183
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This trial compared the rate and time of viral clearance in subjects receiving a combination of nitazoxanide, ribavirin, and ivermectin plus Zinc versus those receiving supportive treatment. This non-randomized controlled trial included 62 patients on the triple combination treatment versus 51 age- and sex-matched patients on routine supportive treatment. all of them confirmed cases by positive reverse-transcription polymerase chain reaction of a nasopharyngeal swab. Trial results showed that the clearance rates were 0% and 58.1% on the 7th day and 13.7% and 73.1% on the 15th day in the supportive treatment and combined antiviral groups, respectively. The cumulative clearance rates on the 15th day are 13.7% and 88.7% in the supportive treatment and combined antiviral groups, respectively. This trial concluded by stating that the combined use of nitazoxanide, ribavirin, and ivermectin plus zinc supplement effectively cleared the SARS-COV2 from the nasopharynx in a shorter time than symptomatic therapy.
