scholarly journals Assessing Validity of Self-Reported Dietary Intake within a Mediterranean Diet Cluster Randomized Controlled Trial among US Firefighters

Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2250 ◽  
Author(s):  
Mercedes Sotos-Prieto ◽  
Costas Christophi ◽  
Alicen Black ◽  
Jeremy D Furtado ◽  
Yiqing Song ◽  
...  

Collecting dietary intake data is associated with challenges due to the subjective nature of self–administered instruments. Biomarkers may objectively estimate the consumption of specific dietary items or help assess compliance in dietary intervention studies. Our aim was to use a panel of plasma and urine biomarkers to assess the validity of self-reported dietary intake using a modified Mediterranean Diet Scale (mMDS) among firefighters participating in Feeding America’s Bravest (FAB), an MD cluster-randomized controlled trial. In our nested biomarker pilot study, participants were randomly selected from both the MD intervention group (n = 24) and the control group (n = 24) after 12-months of dietary intervention. At baseline data collection for the pilot study (t = 12-months of FAB), participants in the control group crossed-over to receive the MD intervention (active intervention) for 6-months. Participants in the intervention group continued in a self-sustained continuation phase (SSP) of the intervention. Food frequency questionnaires (FFQ), 13-item-mMDS questionnaires, 40 plasma fatty acids, inflammatory biomarkers and urinary hydroxytyrosol and tyrosol were analyzed at both time points. Spearman’s correlation, t-tests and linear regression coefficients were calculated using SAS software. Overall, the mMDS derived from the FFQ was highly correlated with the specific 13-domain-mMDS (r = 0.74). The concordance between the two questionnaires for low and high adherence to MD was high for all the participants in the parent trial (κ = 0.76). After 6 months of intervention in the pilot study, plasma saturated fatty acid decreased in both groups (active intervention: −1.3 ± 1.7; p = 0.002; SSP: −1.12 ± 1.90; p = 0.014) and oleic acid improved in the SSP (p = 0.013). Intake of olive oil was positively associated with plasma omega-3 (p = 0.004) and negatively with TNF-α (p < 0.001) at baseline. Choosing olive oil as a type of fat was also associated with higher levels of plasma omega-3 (p = 0.019) at baseline and lower TNF-α (p = 0.023) at follow up. Intake of red and processed meats were associated with lower serum omega-3 (p = 0.04) and fish consumption was associated with lower IL-6 at baseline (p = 0.022). The overall mMDS was associated with an increase in plasma omega-3 (p = 0.021). Good correlation was found between nutrient intake from the FFQ and the corresponding plasma biomarkers (omega-3, EPA and DHA). In this MD randomized controlled trial, some key plasma biomarkers were significantly associated with key MD diet components and the overall mMDS supporting the validity of the mMDS questionnaire as well as compliance with the intervention.

Author(s):  
Winnie Wing Man Ng ◽  
Anthony Siu Wo Wong ◽  
Kin Cheung

This cluster randomized controlled trial (CRCT)-designed study aimed to explore the feasibility of a promotion pamphlet and/or WhatsApp as a suitable mode of delivery to promote healthy eating habits with fruit and vegetables (F&V) among firefighters. Convenience and snowball sampling methods were used. Forty-five firefighters from 23 fire stations were recruited and they all received the printed pamphlet, while the intervention group participants (n = 20) received additional teaching material through WhatsApp every two weeks for eight weeks. Feasibility outcomes included retention, practicality, and implementation. The participants reported high levels of satisfaction with the intervention. There were significant improvements in the mean numbers of days consuming F&V (p = 0.002; p = 0.031) in the intervention group, and for fruit consumption (p = 0.033) in the control group between the baseline (T0) and 3 months after completion of intervention (T1). High levels of participants’ satisfaction with the intervention revealed that a full-scale CRCT of the WhatsApp-delivered intervention promoting healthy eating could be feasible, especially as a means of increasing the numbers of days they consumed F&V and the numbers of servings of these consumed per day.


2020 ◽  
Vol 21 (8) ◽  
pp. 1028-1036
Author(s):  
Takeo Fujiwara ◽  
Aya Isumi ◽  
Makiko Sampei ◽  
Yusuke Miyazaki ◽  
Fujiko Yamada ◽  
...  

Abstract This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02–0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27–1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.


2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.


2021 ◽  
Vol 9 ◽  
Author(s):  
Arya Rahul ◽  
Sujatha Chintha ◽  
Thekkumkara Surendran Anish ◽  
Kannamkottapilly Chandrasekharan Prajitha ◽  
Pillaveetil Sathyadas Indu

Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings.Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling.Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p &lt; 0.001) and PPBS (p &lt; 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05–2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = −3.1, SE = 0.57; p &lt; 0.001) and PPBS (B = −0.81, SE = 0.3; p &lt; 0.001) with time. Drug adherence score (p &lt; 0.001), hours of physical activity (p &lt; 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p &lt; 0.001) adjusting for baseline values.Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients.Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jose Maria Montero-Moraga ◽  
Margarita Posso ◽  
Marta Román ◽  
Andrea Burón ◽  
Maria Sala ◽  
...  

Abstract Objective To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women’s participation. Methods This cluster randomized controlled trial was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50–69 years invited to screening between September 2019 and January 2020. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. The clusters consisted of the processing days of the invitation letter, assigned to the intervention with a simple random allocation scheme. We compared the participation rate at the individual level between groups, stratified by hospital and by per-protocol and intention-to-treat analyses. Results We included 11,119 women (137 clusters): 5416 in the intervention group (66 clusters) and 5703 in the control group (71 clusters). A total of 36% (1964/5393) of the women in the intervention group and 37% (2135/5694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation − 1.1%; 95%CI; − 2.9 to 0.7%). In a hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (− 1.4, 95%CI: − 5.7% to − 0.03%). Conclusions Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status Trial registration Trial registration number ISRCTN13848929.


Author(s):  
Kim Dockx ◽  
Hans Van Remoortel ◽  
Emmy De Buck ◽  
Charlotte Schelstraete ◽  
An Vanderheyden ◽  
...  

Nearly 90% of diarrhea-related mortalities are the result of unsafe drinking water, poor sanitation, and insufficient hygiene. Although “Water, Sanitation, and Hygiene” (WASH) interventions may significantly reduce the risk of diarrheal disease, it is currently unclear which interventions are the most effective. In this study, we aim to determine the importance of contextualizing a WASH intervention to the local context and the needs for increasing impact (Clinicaltrials.gov NCT03709368). A total of 1500 households in rural Tanzania will participate in this cluster randomized controlled trial. Households will be randomized into one of three cohorts: (1) a control group receiving a basic intervention and 1 placebo household visit, (2) an intervention group receiving a basic intervention + 9 additional household visits which are contextualized to the setting using the RANAS approach, and (3) an intervention group receiving a basic intervention + 9 additional household visits, which are not contextualized, i.e., a general intervention. Assessments will take place at a baseline, 1 and 2 years after the start of the intervention, and 1 year after the completion of the intervention. Measurements involve questionnaires and spot checks. The primary outcome is hand-washing behavior, secondary objectives include, the impact on latrine use, health, WASH infrastructure, quality of life, and cost-effectiveness.


2019 ◽  
Vol 10 ◽  
pp. 215013271984737 ◽  
Author(s):  
Wichai Aekplakorn ◽  
Valla Tantayotai ◽  
Sakawduan Numsangkul ◽  
Nutchanat Tatsato ◽  
Pranee Luckanajantachote ◽  
...  

Objectives: Lifestyle interventions have been shown to effectively reduce the incidence of diabetes, but evidence from middle-income countries is scarce. We evaluated the effectiveness of a lifestyle program to prevent diabetes in primary-care settings in Thailand. Methods: A matched-pair cluster randomized controlled trial was conducted in 68 primary care units in 8 provinces. The primary care units were randomly assigned to intervention or control arms. Individuals aged 30 to 65 years with impaired oral glucose tolerance were recruited and followed up for 2 years. The intervention included periodic group-based activities on healthy lifestyle behaviors; the control group received a one-time education program. The primary outcome was the incidence rate of type 2 diabetes at 24 months after the intervention. Results: A total of 1903 individuals participated (873 in the control group and 1030 in the intervention group). At baseline, participants’ characteristics did not differ between groups. After 24 months, the incidence rates (per 100 person-year) of diabetes was 12.1% (95% CI 10.7% to 13.8%) in the intervention group, and 16.6% (95% CI 14.6 to 18.8%) in the control group ( P < .001). Overall, the adjusted hazard ratio for diabetes incidence was 0.72 (95% CI 0.60 to 0.86). A mean body weight reduction of 1.5 kg was observed in the intervention group, whereas, an increase of 0.4 kg was observed in the control group ( P < .001). Conclusion: A community-based lifestyle modification through participatory group activities can prevent or delay the incidence of diabetes among Thai populations with impaired glucose tolerance.


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Sajid Soofi ◽  
Gul Nawaz ◽  
Cecilia Garzon

Abstract Objectives We evaluated the effectiveness of a locally produced lipid-based nutrient supplement - medium-quantity (LNS-MQ) known as Wawamum to prevent stunting in children 6–23 months of age in Thatta and Sujawal districts of Sindh province, Pakistan. Methods A cluster randomized controlled trial was conducted and a total of 870 children between 6–18 months old were enrolled. Children in the intervention group received 50 grams/day of Wawamum for 6 months, while children in the control group received standard government health services, not including Wawamum. The primary outcome was stunting risk reduction among children 6–23 months of age. Results Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88–0.94, P < 0.001) and wasting (RR = 0.78, 95% CI; 0.67–0.92, p-0.004) as compared to children who received the standard government health services. A non-significant impact was observed on underweight (RR = 0.94, 95% CI; 0.85–1.04, p-0.241) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94–0.99, p-0.008). The reduction in risk of severe anaemia was even more evident (RR = 0.45, 95% CI; 0.28–0.99, p-0.002) in the intervention group than in the control group. The mean compliance of Wawamum was 60.3% among children. Conclusions The study confirmed the plausibility of achieving nutrition gains in the short-term with a locally produced LNS-MQ, known as Wawamum, through the primary health care system. The risk of stunting and wasting was reduced by 9% and 22%, respectively. The statistically significant reduction in risk of stunting, wasting and anaemia among children 6–23 months of age showed that an immediate improvement in these nutrition indicators is indeed possible. This approach can be scaled up in similar settings to achieve positive outcomes for nutrition and health. Funding Sources World Health Organization.


Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3732
Author(s):  
Eleonora Bruno ◽  
Andreina Oliverio ◽  
Angelo Virgilio Paradiso ◽  
Antonella Daniele ◽  
Stefania Tommasi ◽  
...  

Background: Women carriers of BRCA1/2 mutations face a high lifetime risk (penetrance) of developing breast and/or ovarian cancer. Insulin-like growth factor I (IGF-I), body weight and markers of insulin resistance affect BRCA penetrance. We conducted a multicenter prospective two-armed (1:1) randomized controlled trial (NCT03066856) to investigate whether a Mediterranean dietary intervention with moderate protein restriction reduces IGF-I and other metabolic modulators of BRCA penetrance. Methods: BRCA carriers, with or without a previous cancer, aged 18–70 years and without metastases were randomly assigned to an active dietary intervention group (IG) or to a control group (CG). The primary endpoint of the intervention was the IGF-I reduction. Results: 416 women (216 in the IG and 200 in the CG) concluded the six-month dietary intervention. The IG showed significantly lowered serum levels of IGF-I (−11.3 ng/mL versus −1.3 ng/mL, p = 0.02), weight (−1.5 Kg versus −0.5 Kg, p < 0.001), waist circumference (−2 cm versus −0.7 cm, p = 0.01), hip circumference (−1.6 cm versus −0.5 cm, p = 0.01), total cholesterol (−10.2 mg/dL versus −3.6 mg/dL, p = 0.04) and triglycerides (−8.7 mg/dL versus + 5.5 mg/dL, p = 0.01) with respect to the CG. Conclusions: A Mediterranean dietary intervention with moderate protein restriction is effective in reducing IGF-I and other potential modulators of BRCA penetrance.


Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3081
Author(s):  
Matthew J. Landry ◽  
Alexandra E. van den Berg ◽  
Deanna M. Hoelscher ◽  
Fiona M. Asigbee ◽  
Sarvenaz Vandyousefi ◽  
...  

School gardens have become common school-based health promotion strategies to enhance dietary behaviors in the United States. The goal of this study was to examine the effects of TX Sprouts, a one-year school-based gardening, cooking, and nutrition cluster randomized controlled trial, on students’ dietary intake and quality. Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to control (i.e., delayed intervention) over three years (2016–2019). The intervention arm received: formation and training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly in the teaching garden during school hours; and nine parent lessons, taught monthly. Dietary intake data via two 24 h dietary recalls (24 hDR) were collected on a random subsample (n = 468). Dietary quality was calculated using the Healthy Eating Index 2015 (HEI-2015). The intervention group compared to control resulted in a modest increase in protein intake as a percentage of total energy (0.4% vs. −0.3%, p = 0.021) and in HEI-2015 total vegetables component scores (+4% vs. −2%, p = 0.003). When stratified by ethnicity/race, non-Hispanic children had a significant increase in HEI-2015 total vegetable scores in the intervention group compared to the control group (+4% vs. −8%, p = 0.026). Both the intervention and control groups increased added sugar intake; however, to a lesser extent within the intervention group (0.3 vs. 2.6 g/day, p = 0.050). School-based gardening, cooking, and nutrition interventions can result in significant improvements in dietary intake. Further research on ways to scale and sustain nutrition education programs in schools is warranted. The trial is registered at ClinicalTrials.gov (NCT02668744).


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