Multidisciplinary study of the health and nutritional status of persons living in households at risk of poverty with children in Germany (MEGA_kids): Study design and methods.

Background: In Germany, the nutritional situation of adults and children living in households at risk of poverty has been insufficiently studied so far. Aim: The aim of the mixed-methods study MEGA_kids is to gain a deeper understanding of the nutritional situation including socioeconomic, behavioral, and attitudinal factors and health characteristics among persons living in families at risk of poverty. Method: MEGA_kids is a mixed-methods cross-sectional study consisting of four modules combining quantitative and qualitative methods. The first module (A) applies self-administered questionnaires to assess the individual's diet, household food insecurity, and several other factors among adults and children of 500 households. Cash receipts are used to assess household's food expenses. For the second module (B), a semistructured interview guide is used to identify factors influencing food security and nutritional quality from the perspective of a subsample of module A (n = 20). The third module (C) applies the participatory World Café technique to explore experiences and generate ideas for tailored support measures for a healthy diet from the perspective of 40 parents participating in module A. Finally, the fourth module (D) investigates the knowledge and usage of existing nutrition-related preventive measures among 200 parents at risk of poverty by using an online questionnaire. Conclusion: By providing a comprehensive picture of nutritional aspects of families living at risk of poverty, MEGA_kids will guide officials to target and prioritize public health nutrition measures, inform policy makers to implement and improve healthy policies and, finally, identify research gaps to be prioritized.

Hypnotherapy, Intermittent Fasting, and Exercise Group Programs in Atopic Dermatitis: A Randomized Controlled Explorative Clinical Trial During the COVID-19 Pandemic.

Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.

Impact of a smoking cessation program on smoking prevalence and food security among food pantry users - a study protocol for a pragmatic cluster randomised controlled trial.

BACKGROUND: Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users. METHODS / DESIGN: Before starting the cluster randomised controlled trial, stakeholders will be engaged to adapt a behavioural group counselling program for smoking cessation to the needs of the food pantry users in a pre study. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews and a qualitative thematic analysis for data analysis to design the concept of the intervention program will be applied. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes 6 months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level). DISCUSSION: This study will be the first long-term investigation into the effect of a smoking cessation program on smoking status and food insecurity. The results of this study will inform the implementation of smoking cessation programs in food pantries throughout Germany. TRIAL REGISTRATION: Prospectively registered DRKS00020037 . Registered 29 April 2020.