Study design and baseline characteristics of a combined educational and environmental intervention trial to lower sodium intake in Swiss employees.

BACKGROUND: Blood pressure is a primary cardiovascular disease risk factor. Population-wide governmental strategies aim to reduce lifestyle and dietary risk factors for hypertension, one of which is an unbalanced diet with high sodium and low potassium intakes. Nutrition interventions in the workplace are considered a promising approach in encouraging health-promoting behaviors. We developed and conducted the health promoting sodium reduction trial "Healthful & Tasty: Sure!" in worksites in the German-speaking part of Switzerland from May 2015 to Nov 2016, for which we present the study protocol and baseline characteristics. METHODS: Healthful & Tasty, a cluster nonrandomized single-arm trial with calibration arm, aimed to demonstrate the effectiveness of a combined educational and environmental intervention in the workplace in reducing employees' average daily sodium/salt intake by 15%. To this end, health and food literacy of employees and guideline compliance among the catering facility team needed to be improved. The primary outcome measure was sodium/salt intake estimated from sodium excretion in a 24-h urine sample. Secondary outcome measures included changes in the overall qualitative diet composition, blood pressure, anthropometric indices, and health and food literacy. Of eight organizations with catering facilities, seven organizations took part in the nutrition education and catering salt reduction interventions, and one organization participated as a control. Overall, 145 consenting employees were included in the staggered, one-year four-phase trial, of which 132 participated in the intervention group. In addition to catering surveys and food sampling, the trial included five follow-up health assessments including questionnaires, blood pressure measurements, anthropometrics, and sodium, potassium, and iodine intake measurements obtained from 24-h and spot urine samples, and a food record checklist. Exploratory and hypothesis generating baseline statistical analysis included 141 participants with adequate 24-h urine samples. DISCUSSION: Despite practice-driven limitations to the study design and small cluster and participant numbers, this trial has methodological strength and will provide important insights into the effectiveness of a combined educational and environmental intervention to reduce salt intake among female and male Swiss employees. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00006790 . Registered 23 September 2014.

The efficacy and real-world effectiveness of a diet low in fermentable oligo-, di-, monosaccharides and polyols in irritable bowel syndrome: A systematic review and meta-analysis.

BACKGROUND & AIMS: A diet low in fermentable oligo-, di-, monosaccharides, and polyols (LFD) has been shown to effectively reduce irritable bowel syndrome (IBS) symptoms. Effects resulting from real-world studies may differ from those seen in efficacy studies because of the diversity of patients in real-world settings. This systematic review and meta-analysis aimed to compare the effect of the LFD on reducing IBS symptoms and improving the quality of life (QoL) in efficacy trials and real-world studies. METHODS: Major databases, trial registries, dissertations, and journals were systematically searched for studies on the LFD in adults with IBS. Meta-analysis was conducted using a random effects model with standardized mean differences (SMD) and 95% confidence intervals (CI). Outcomes of interest were all patient-reported: stool consistency, stool frequency, abdominal pain, overall symptoms, adequate symptom relief, IBS-specific QoL and adherence to the LFD. RESULTS: Eleven efficacy and 19 real-world studies were reviewed. The meta-analysis results for abdominal pain (SMD 0.35, 95% CI 0.16 to 0.54) and QoL (SMD 0.23, 95% CI -0.05 to 0.50) showed the LFD was beneficial in efficacy studies with no statistically significant results for stool frequency (SMD 0.71, 95% CI 0.34 to 1.07). Real-world studies found improvements in abdominal pain and QoL. Due to heterogeneity, no meta-analysis was done for stool consistency and overall symptoms. In these outcomes, results were mostly supportive of the LFD, but they were not always statistically significant. CONCLUSIONS: The results of this systematic review and meta-analysis suggest the LFD improves outcomes compared to a control diet (efficacy studies) or baseline data (real-world studies). Because of diverse study designs and heterogeneity of results, a clear superiority of the LFD over control diets could not be concluded. There are no indications of an efficacy-effectiveness gap for the LFD in adults with IBS.

The Efficacy of a Diet Low in Fermentable Oligo-, Di-, Monosaccharides, and Polyols in Irritable Bowel Syndrome Compared to Its "Real-world" Effectiveness: Protocol for a Systematic Review.

BACKGROUND: Irritable bowel syndrome (IBS) is associated with various gastrointestinal and nongastrointestinal symptoms and reduced quality of life. A diet low in fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) is one therapeutic option for IBS. Although the efficacy of the low FODMAP diet has been reported in several systematic reviews, the efficacy-effectiveness gap of the low FODMAP diet has not yet been assessed. OBJECTIVE: This systematic review aims to compare the efficacy of the low FODMAP diet from efficacy randomized controlled trials (RCTs) with the effectiveness of studies conducted in "real-world" settings. METHODS: RCTs, prospective and retrospective cohort studies, and retrospective audits assessing the low FODMAP diet in adults with IBS will be searched in 4 databases: Embase, MEDLINE, CENTRAL, and CINAHL. Two independent reviewers will perform study selection, data extraction, and risk of bias assessment and assess selected quality aspects from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol. Outcomes assessed are stool frequency, stool consistency, abdominal pain, overall symptom scores, adequate symptom relief, IBS-specific quality of life, and diet adherence. Data will be summarized with forest plots without summary statistics, tables, and narrative descriptions. RESULTS: The search, title and abstract screening, and full-text screening were completed in March 2021, and an updated search was done in May 2022. As of May 2023, data analysis is almost finished, and manuscript writing is in progress. Submission of the manuscript is expected by July 2023. CONCLUSIONS: The findings of this systematic review will compare the efficacy of the low FODMAP diet for IBS found in RCTs to the diet's real-world effectiveness. TRIAL REGISTRATION: PROSPERO CRD42021278952; https://tinyurl.com/32jk43ev. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41399.

RE-AIM evaluation of a one-year trial of a combined educational and environmental workplace intervention to lower salt intake in Switzerland.

Reducing excessive dietary sodium may reduce cardiovascular disease risk. Environmental and behavioral interventions in workplaces may reduce salt consumption, but information on the effectiveness of workplace nutrition interventions is sparse. We used the RE-AIM framework to evaluate a one-year trial in 2015-2016 of an educational and environmental intervention to lower salt intake of employees in organizations with catering facilities in Switzerland. Five educational workshops for employees and assessments that included 24-hour urine collection were combined with five coaching sessions and food analyses in catering operations. We studied the adoption, reach, implementation, effectiveness, and maintenance of the intervention. Eight of 389 candidate organizations participated in the trial in which 145 (50% men) out of 5794 potentially eligible employees consented to participate, and 138 completed the trial with 13 in the control group. The overall mean change of daily salt intake was -0.6 g from 8.7 g to 8.1 g (6.9%). Though the mean daily salt intake of women was unaltered from 7 g, the mean intake of men declined by -1.2 g from 10.4 g to 9.2 g. Baseline salt intake, sex, and waist-to-height ratio were significant predictors of salt reduction. The analysis also highlighted pivotal determinants of low adoption and reach, and program implementation in catering operations. We conclude that a workplace program of nutrition intervention for employees and catering staff is feasible. The acceptance, effectiveness, and maintenance of nutrition interventions in the workplace require strong employer support. In a supportive food environment, interventions tailored to sex, age, and CVD risk inter alia could be successful.