RESUMEN
BACKGROUND: The World Health Organization recommends 150 minutes of moderate to vigorous physical activity (PA), which translates to approximately 7000 to 10,000 steps per day for adults. In Germany, less than half of the population in this age range meets this recommendation, highlighting the need for population-based intervention approaches for promoting daily PA. OBJECTIVE: The complex community-based PA intervention "10,000 Steps Ghent," which was originally developed in Belgium and was shown to be effective for PA promotion, has been adapted for implementation and evaluation in 2 German cities. The original Belgian study is currently being replicated, and we aim to examine the effectiveness of the adapted intervention among adults living in intervention city districts in Duesseldorf when compared with those living in control city districts in Wuppertal, over the course of 1 year. METHODS: A controlled intervention trial examining the effects of an intervention addressing multiple levels (eg, individual level: website; organizational level: PA promotion in companies; community level: media campaigns and environmental changes) is being conducted. PA and various secondary outcomes will be assessed in 2 random samples of adults aged 25 to 75 years (n=399 in each city) at baseline and after 1 year. RESULTS: Funding for this study was obtained in March 2020. Recruitment for this study and baseline data collection were conducted from May 2021 to March 2022 (as of March 2022, 626 participants were enrolled in the study). The intervention will be implemented in Duesseldorf for 1 year from April 2022 onward, and follow-up assessments will be conducted, starting in May 2023 (until September 2023). Data analysis will be performed in fall 2023, and the results will be published in spring 2024. CONCLUSIONS: To our knowledge, this is the first research project (currently underway in Germany) that is aimed at replicating the effects of a complex intervention for PA promotion that was previously shown to be effective in another European country. TRIAL REGISTRATION: German Clinical Trials Register DRKS00024873; https://tinyurl.com/4c9e8azh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39175.
RESUMEN
Epidemiological studies suggest that high intake of soy isoflavones may protect against breast cancer, but causal relationships can only be established by experimental trials. Thus, we aimed to provide a systematic review of randomized controlled trials (RCTs) on the effect of an isoflavone intake on risk factors of breast cancer in healthy subjects. After a systematic literature search in PubMed, 18 different RCTs with pre- and/or postmenopausal women were included and investigated for details according to the PRISMA guideline. In these studies, isoflavones were provided by soy food or supplements in amounts between 36.5-235 mg/d for a period of 1-36 months. Breast density, estrogens including precursors, metabolites, estrogen response such as length of menstrual cycle, and markers of proliferation and inflammation were considered. However, in most studies, differences were not detectable between isoflavone and control/placebo treatment despite a good adherence to isoflavone treatment, irrespective of the kind of intervention, the dose of isoflavones used, and the duration of isoflavone treatment. However, the lack of significant changes in most studies does not prove the lack of effects as a sample size calculation was often missing. Taking into account the risk of bias and methodological limitations, there is little evidence that isoflavone treatment modulates risk factors of breast cancer in pre- and postmenopausal women. Future studies should calculate the sample size to detect possible effects and consider methodological details to improve the study quality.