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Anthropometric and Body Composition Data | Participants who were unable to come to the study site were asked to provide a self-reported weight. These weights were not included in the final analyses, but the number of participants self-reporting weights are included in the CONSORT diagram to indicate continued engagement with the study ( | PMC9857469 | ||
Dietary and Questionnaire Data | Participants completed three 24-hour dietary recalls, which were averaged to create a mean energy intake at each time point (baseline and 3, 6, 12, and 24 months). Participants were also asked what medications they were currently taking. Dietary adherence was assessed by examining recommended animal product intake for ... | PMC9857469 | ||
CVD Risk Factors | CVD, blood pressure | To assess changes in risk factors for CVD, blood pressure was taken along with a fasting lipid panel (total, LDL, and high-density lipoprotein cholesterol, and triglycerides), glucose, and insulin. Details on these procedures have been provided elsewhere. | PMC9857469 | |
Dietary and Behavioral Interventions | Apart from the diet prescribed, participants received similar behavioral interventions. Participants attended weekly group-based classes for 6 months, biweekly for 6 months, and monthly for 12 months. Participants were provided with additional electronic content: a website to access study materials and recordings of cl... | PMC9857469 | ||
CONSERVE (CONSORT and SPIRIT Extension for Randomized Clinical Trials Revised in Extenuating Circumstances) Detailing the Alterations Made to Intervention and Assessments Based on COVID-19 | Questionnaires were all conducted online. In-person weight and laboratory assessments were delayed until June 2020 when approval from the university was granted. The following adjustments were made to laboratory procedures to ensure social distancing and safety of participants:Appointment times were lengthened to avoid... | PMC9857469 | ||
Statistical Analysis | weight loss | Data analysis was performed from March to June 2022. The study statisticians (E.A.F. and B.H.) were blinded to group assignment when completing all analyses. Descriptive statistics were used to present baseline characteristics, and independent Subanalyses were also conducted to examine 12-month weight loss in cohort 1 ... | PMC9857469 | |
Results | The CONSORT diagram for the study is shown in | PMC9857469 | ||
Main Outcomes of Weight Loss and Changes in Lipids, by Group | high-density lipoprotein | Abbreviations: HDL, high-density lipoprotein; LDL, low-density lipoprotein; VLDL, very-low-density lipoprotein.SI conversion factors: To convert HDL cholesterol to millimoles per liter, multiply by 0.0259; LDL cholesterol to millimoles per liter, multiply by 0.0259; total cholesterol to millimoles per liter, multiply b... | PMC9857469 | |
Changes in Secondary Outcomes of Energy Intake, Body Composition, and Glucose, Insulin, and Blood Pressure, by Group | pandemic).Weight loss, Weight loss, weight loss, hypertensive | SI conversion factors: To convert glucose to millimoles per liter, multiply by 0.0555; high-density lipoprotein cholesterol to millimoles per liter, multiply by 0.0259; insulin to picomoles per liter, multiply by 6.945.All models were adjusted for baseline socioeconomic status (education and employment), food security ... | PMC9857469 | |
Discussion | Weight loss, weight loss | CVD, HEART | NEW Soul is one of the first long-term, randomized clinical trials comparing the effects of 2 different healthy soul food diets on changes in body weight and CVD risk factors among African American individuals. Although most outcomes were in the hypothesized direction, there were no differences between the groups, and ... | PMC9857469 |
Limitations | CVD | The results of this study should be considered within the context of its limitations. The study population was highly educated, mostly women, and living in the South and, therefore, may not be generalizable to other populations. Although objective measures were used for weight, body composition, and CVD risk factors, d... | PMC9857469 | |
Conclusions | weight loss | CVD | In this randomized clinical trial examining weight loss and CVD risk factor reduction among African American individuals, there were no significant differences in weight loss and changes in lipids and blood pressure among African American individuals randomized to either healthy soul food vegan or omnivorous diets. The... | PMC9857469 |
References |
Trial Protocol and Statistical Analysis Plan
Click here for additional data file.
Data Sharing Statement
Click here for additional data file. | PMC9857469 | ||
Background: | fatigue, anxiety, cancer, depression, Cancer | CANCER, CANCER | Cancer patients often suffer from psychological symptoms and need psychological support. Especially during the COVID-19 pandemic, eHealth interventions might be helpful to overcome the obstacles of the pandemic. This study evaluates the effectiveness of a video sequence-based eHealth intervention on anxiety, fatigue, a... | PMC9940180 |
Methods: | tumor, anxiety | TUMOR, SECONDARY | Patients (N = 157) with different tumor entities were randomly assigned to the video intervention group (IG) and the waiting control group (CG). Patients in the IG received a video intervention comprising 8 video sequences over 4 weeks. The videos included psychoeducation on distress and psychological symptoms, Accepta... | PMC9940180 |
Results: | anxiety | Patients of the IG showed no significant improvement in anxiety (GAD-7; | PMC9940180 | |
Conclusions: | The video intervention was ineffective in reducing the psychological burden compared to a waiting CG. The findings support prior observations of the value of therapeutic guidance and promoting self-management for improving patients’ psychological burdens. Further studies are required to evaluate the effectiveness of ps... | PMC9940180 | ||
Introduction | tumor, fatigue, anxiety, cancer, depression | CANCER, TUMOR | Every year about 500.000 people in Germany develop cancer.The COVID-19 pandemic could have worsened these problems,We hypothesized:(1) The participants in the video sequence-based IG will have significantly more improved anxiety levels and fear of progression than the participants in the waiting CG after the end of the... | PMC9940180 |
Methods | PMC9940180 | |||
Trial Design | tumor, Cancer | TUMOR, CANCER | The study was a single-center, prospective, randomized, controlled intervention study with a waiting CG performed at the University Hospital of Wuerzburg, Comprehensive Cancer Center Mainfranken (CCCMF). The Ethics Committee of the University of Würzburg approved the study on 23.04.2021 (Nr. 123/20-me).Cancer patients ... | PMC9940180 |
Participants | malignant tumor disease | The inclusion criteria were a malignant tumor disease in the history of the patient, a minimum age of 18 years, and informed consent to participate in the study. There was no preselection regarding the current stress level. Exclusion criteria were insufficient German language ability and severe physical or mental impai... | PMC9940180 | |
Intervention | Overall, the intervention comprised 8 videos, each about 10 to a maximum of 30 minutes in length. The structure of all units was similar. Each sequence started with imparting knowledge on the respective topic. There was both an explanation of the backgrounds and meanings of the respective symptoms and assistance using ... | PMC9940180 | ||
Measures | PMC9940180 | |||
Statistical Analysis | breast cancer, tumor, hem, hemato-oncological malignancies | BREAST CANCER, TUMOR, DELETION | For the analysis, the differences in the outcomes of T1 and T2 were calculated to retain the target variable change. These changes were compared between IG and CG. Questionnaires with missing values were removed from the evaluation. Thus, outcomes were analyzed by pair-wise deletion. Shapiro-Wilk and Levene tests were ... | PMC9940180 |
Results | PMC9940180 | |||
Intervention Adherence and Evaluation | The intervention had a high level of acceptance as 93.9% stated that their initial expectations regarding the intervention were at least more likely to be fulfilled and 88.2% stated they would be at least likely to participate in such an intervention again, and 98.5% would recommend it to other patients. Mean ratings o... | PMC9940180 | ||
Discussion | tumor, fatigue, anxiety, cancer, depression | CANCER, TUMOR, BLIND | This study showed no improvement in anxiety, fatigue, and depression after a 4-week eHealth intervention in video sequences compared to a waiting CG. A follow-up study 3 months after the end of the intervention will examine the possible long-term changes. Though the results of IG and CG did not significantly differ, th... | PMC9940180 |
Conclusions | fatigue, depression, anxiety | The intervention could not improve the anxiety, fear of progression, fatigue, or depression compared to the waiting CG. However, both groups showed decreased symptoms during the intervention period. In addition, there was high satisfaction and adherence with the intervention among the participants of the IG. Hence, our... | PMC9940180 | |
Supplemental Material | PMC9940180 | |||
References | PMC9940180 | |||
Background | Overconsumption is one of the most serious public health challenges in the UK and has been linked to increased consumption of food ordered through delivery platforms. This study tested whether repositioning foods and/or restaurant options in a simulated food delivery platform could help to reduce the energy content of ... | PMC10197857 | ||
Methods | REGRESSIONS | UK adult food delivery platform users (N = 9,003) selected a meal in a simulated platform. Participants were randomly allocated to a control condition (choices listed randomly) or to one of four intervention groups, (1) food options listed in ascending order of energy content, (2) restaurant options listed in ascending... | PMC10197857 | |
Results | The energy content of participants’ baskets in the control condition was 1382 kcals. All interventions significantly reduced energy content of baskets: Compared to control, repositioning both foods and restaurants purely based on energy content of options resulted in the greatest effect (-209kcal; 95%CIs: -248,-168), f... | PMC10197857 | ||
Conclusions | This proof-of-concept study suggests repositioning lower-energy options more prominently may encourage lower energy food choices in online delivery platforms and can be implemented in a sustainable business model. | PMC10197857 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12966-023-01456-8. | PMC10197857 | ||
Keywords | PMC10197857 | |||
Background | OVERWEIGHT AND OBESITY | Overweight and obesity contribute to poor health globally [Analyses of major UK restaurant chains showed that only 9% of dishes had an energy content of less than 600 kcals a meal, and 47% of dishes were at least 1000 kcals or more, which equates to half of the daily-recommended energy intake for a woman [The environme... | PMC10197857 | |
Methods | PMC10197857 | |||
Design | This was a five-arm randomised controlled trial. Participants were recruited to obtain a UK representative sample, with specific quotas set for age, gender, location, and income. Quotas were set based on data from the UK Office for National Statistics [ | PMC10197857 | ||
Interventions | This study was conducted using ‘Take a BITe’, a simulated food delivery platform created and hosted by the Behavioural Insights Team. The platform has a similar design to real-world food delivery platforms such as Deliveroo, UberEats, and JustEat. There were 21 restaurants and 570 food or drink items, each in three dif... | PMC10197857 | ||
Participant recruitment | Participants were required to be users of a food delivery platform and adults (18 years or older) living in the UK. Our study aimed to collect data from 9,000 participants in order to be powered to detect a 65 kcal reduction in total energy, with a standard deviation estimated at 550 kcal, 80% power, 5% significance le... | PMC10197857 | ||
Ethics | Ethics approval was granted for the study protocol by the Central University Research Ethics Committee (Ref: R65010/007). The protocol was pre-registered on the Open Science Framework ( | PMC10197857 | ||
Results | The study was run from February to March 2022. 15,051 entrants were assessed for eligibility to participate. 5,148 were excluded for failing to meet inclusion criteria or failing attention checks. 9,293 completed the study task, but 290 were excluded from analysis because their hypothetical order baskets contained eith... | PMC10197857 | ||
Discussion | All the interventions tested in this study reduced the energy content of participants’ baskets, showing as a proof-of-concept that these approaches might have the potential to lower energy purchased from food delivery platforms. The greatest decrease was in the intervention that repositioned both foods and restaurants ... | PMC10197857 | ||
Conclusions | Repositioning of products and restaurants to make lower energy options more prominent in a simulated online delivery platform effectively reduced the amount of energy in recipients’ baskets. Although all interventions were effective, changing the order of both the foods and the restaurants was more effective than alter... | PMC10197857 | ||
Acknowledgements | Not applicable. | PMC10197857 | ||
Authors’ contributions | RP, FM | FB, LB, JB, SK, JF, JL, AM, FM, RP, HH, and SAJ contributed to the study design. ML and SK, JF, FM analysed data and performed statistical analysis. ML wrote the manuscript. All authors made critical revisions and approved the final version of the manuscript. | PMC10197857 | |
Funding | Obesity, RP | OBESITY | This research was funded by NESTA. RP is funded by a Royal Society and Wellcome Trust Sir Henry Dale fellowship (222566/Z/21/Z). SAJ, ML and LB are funded by NIHR Applied Research Collaborations Oxford. SAJ is also funded by the National Institute of Health Research Oxford Biomedical Research Centre (BRC) Obesity, Diet... | PMC10197857 |
Data Availability | Data will be made available upon request. | PMC10197857 | ||
Declarations | PMC10197857 | |||
Ethics approval and consent to participate | Ethics approval was granted for the study protocol by the Central University Research Ethics Committee (Ref: R65010/007). The protocol was pre-registered on the Open Science Framework ( | PMC10197857 | ||
Consent for publication | Not applicable. | PMC10197857 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10197857 | ||
List of Abbreviations | Socioeconomic positionBody mass index | PMC10197857 | ||
References | PMC10197857 | |||
Background | pituitary hormone deficiencies, GHD | GROWTH HORMONE DEFICIENCY, SHORT STATURE, GHD | Growth hormone deficiency (GHD) is the commonest endocrine cause of short stature and may occur in isolation (I-GHD) or combined with other pituitary hormone deficiencies. Around 500 children are diagnosed with GHD every year in the UK, of whom 75% have I-GHD. Growth hormone (GH) therapy improves growth in children wi... | PMC10440873 |
Methods/design | GHD | EARLY PUBERTY, SECONDARY, GHD | Evidence suggests that I-GHD children who re-test normal in early puberty reach a FH comparable to that of children without GHD. The GHD Reversal study will include 138 children from routine endocrine clinics in twelve UK and five Austrian centres with I-GHD (original peak GH < 6.7 mcg/L) whose deficiency has reversed ... | PMC10440873 |
Discussion | ADVERSE EFFECTS | If this study shows that a significant proportion of children with presumed I-GHD reversal generate enough GH naturally in puberty to achieve a near FH within the target range, then this new care pathway would rapidly improve national/international practice. An assumed 50% reversal rate would provide potential UK healt... | PMC10440873 | |
Trial registration | EudraCT number: 2020-001006-39 | PMC10440873 | ||
Keywords | PMC10440873 | |||
Background | idiopathic, GHD | EARLY PUBERTY, GROWTH HORMONE DEFICIENCY, GHD | Around 500 children are diagnosed with growth hormone deficiency (GHD) every year in the UK, of whom 75% have idiopathic, isolated GHD (I-GHD) [To make the diagnosis of I-GHD in a short child, the National Institute for Health and Care Excellence (NICE) recommends at least two GH stimulation tests. These tests measure ... | PMC10440873 |
Methods/design | PMC10440873 | |||
Aim | GHD | SECONDARY, GHD |
To assess whether children in established puberty with early GHD reversal who stop growth hormone therapy (GH −) achieve no worse near final height standard deviation scores (FH SDS) (primary outcome), target height (TH) minus near final height (FH), health-related quality of life (HRQoL), bone health index and lipid ... | PMC10440873 |
Study design | The study design is as follows: phase III, international, multicentre, open-label, randomised controlled non-inferiority trial, including an internal pilot study, qualitative sub-study and within-trial cost analysis. The duration of the trial will be 90 months, including a 12-month pilot phase. | PMC10440873 | ||
Sub-studies | PMC10440873 | |||
Health economics | A health economic analysis will be conducted in UK patients to determine the cost-effectiveness of GH discontinuation in the early re-testing scenario in the UK National Health Service (NHS) setting by estimating the cost per percentage of children achieving TH of GH − compared to GH + and the cost-effectiveness of the... | PMC10440873 | ||
Qualitative research | GHD, ’ | RECRUITMENT, GHD | We will conduct qualitative research with UK carers, children and staff participating in the internal pilot study. The main aim of the qualitative research is to ensure the feasibility and acceptability of the trial for patients, carers and clinicians, with a particular focus on recruitment processes. These data will p... | PMC10440873 |
Consent and recruitment | GHD, PIS | GHD | Children with I-GHD reversal under the care of a paediatric endocrinologist and/or a general paediatrician will be recruited from 12 UK and 5 Austrian centres. Administration of GH medication will be stopped for a minimum of 6 weeks prior to a GH re-test being performed in line with local protocols. If the patient is t... | PMC10440873 |
Inclusion and exclusion criteria | PMC10440873 | |||
Inclusion criteria | re-testingAbility | INSULIN TOLERANCE, EVENT |
Children aged 8–15 years of age (inclusive) for females and 9–17 years of age (inclusive) for males with reversed I-GHD (peak GH ≥ 6.7 μg/L using arginine or insulin tolerance test and a serum IGF-1 within normal reference range for sex and age), normal brain MRI (including small anterior pituitary) and in established... | PMC10440873 |
Exclusion criteria | congenital mid-brain malformations, pituitary hormone deficiency, GHD | TUMOURS, HYPOPITUITARISM, SEPTO-OPTIC DYSPLASIA, GHD |
Multiple pituitary hormone deficiency (hypopituitarism) with or without additional pituitary hormone supplementationKnown genetic cause of I-GHDOrganic GHD (mid-brain tumours, congenital mid-brain malformations, septo-optic dysplasia; radiotherapy to the total body or brain)Ectopic posterior pituitaryOther indications... | PMC10440873 |
Randomisation | Following confirmation of patient eligibility, receipt of informed consent and completion of all questions and data items on the randomisation form, the patient will be randomised at the level of the individual in a 1:1 ratio to either continue (GH +) or discontinue (GH −) growth hormone therapy. Randomisation will be ... | PMC10440873 | ||
Planned interventions | Participants in the control arm (GH +) will resume receiving their GH treatment at a dosing level determined by their clinical care team (following the minimum 6-week discontinuation period required prior to randomisation). Participants in the experimental arm (GH −) will not resume GH treatment. Both arms will be foll... | PMC10440873 | ||
Trial schema (Fig. | Trial schemaGHD Reversal Trial schedule of assessments. Three asterisks (***) indicate the following: patients will be followed up until ‘Near FH (growth rate < 2 cm/year and bone age of 14 and 16 for males and females respectively). Given the usual duration of pubertal growth until FH is reached, 3 years follow-up has... | PMC10440873 | ||
Study procedures | GHD | ADVERSE EVENT, GHD | Routine retesting in established puberty is routine clinical practice in all trial sites. Children with GHD persistence at retesting will restart GH; those with GHD reversal will be offered study participation. Following consent, participants will be randomised to GH + (25–35 µg/kg/day) and GH − groups and followed in ... | PMC10440873 |
Sample size and power calculation | Diabetes | DIABETES | Determination of non-inferiority margin was carefully considered, following extensive consultation. A questionnaire was sent to all investigators, British Society for Paediatric Endocrinology and Diabetes clinical study group members, and a patient support group representative (Whilst the percentage of children reachin... | PMC10440873 |
Outcome measures | PMC10440873 | |||
Primary outcome | The primary outcome is as follows: near final height in standard deviation score (FH SDS). | PMC10440873 | ||
Secondary outcomes | Growth related:The proportion of children reaching normal adult height (− 2SD)The proportion reaching mid-parental target height (− 2SD)Difference in child’s target height minus near final height (TH-FH, in SDS and centimetres)Bone related:Bone age delay at near final heightBone age acceleration between enrolment and n... | PMC10440873 | ||
Adverse events | ADVERSE EVENTS | Number of adverse events in each arm.Health economics.Cost per percentage of children in each arm achieving target heightCost per quality-adjusted life year gainedQualitative research:Trial acceptability (parents, patients and recruiting site staff)Reasons for declining participation in the trialParent and patient expe... | PMC10440873 | |
Data management | GHD | GHD | All processes are detailed in the study protocol and in the GHD Reversal Trial data management plan. | PMC10440873 |
Statistical analysis | SECONDARY | A separate statistical analysis plan (SAP) has been produced which provides a more comprehensive description of the planned statistical analyses which is available from the corresponding author on request. The primary comparison groups will be composed of those treated with GH (25–35 μg/kg/day) versus those not treated... | PMC10440873 | |
Primary outcome measure | The primary outcome measure is near FH-SDS (using the WHO Growth Charts [ | PMC10440873 | ||
Secondary outcome measures | REGRESSION, SECONDARY, ADVERSE EVENT | Growth and bone-related secondary outcomes will be considered non-inferiority outcomes and so will be analysed as per the primary outcome using both ITT and per-protocol analyses. Biochemistry and adverse event outcomes will be considered superiority outcomes and so will be analysed using ITT analyses only. Continuous ... | PMC10440873 | |
Subgroup analyses | REGRESSION | Subgroup analyses will be limited to minimisation variables: sex and Tanner stage, for the primary outcome only. Tests for statistical heterogeneity (e.g. by including the treatment group by subgroup interaction parameter in the regression model) will be performed prior to any examination of effect estimate within subg... | PMC10440873 | |
Missing data and sensitivity analyses | EVENT | Every attempt will be made to collect full follow-up data on all trial participants; it is thus anticipated that missing data will be minimal. Participants with missing primary outcome data will not be included in the primary analysis in the first instance. This presents a risk of bias, and sensitivity analyses will be... | PMC10440873 | |
Internal pilot and stopping rules | GHD reversers, GHD | RECRUITMENT, GHD | To ensure the success of the trial, screening data will be kept on the GHD Reversal Trial database on the number of early re-tests, GHD reversers and recruits. No patient identifiable information will be collected at this stage. These data will be analysed and presented as part of the progress report for the trial stee... | PMC10440873 |
Planned interim analysis | SECONDARY | Interim analyses of safety and efficacy for presentation to the independent DMC will take place during the trial. The committee will meet prior to trial commencement to agree the manner and timing of such analyses but this is likely to include the analysis of the primary and major secondary outcomes and full assessment... | PMC10440873 | |
Planned final analyses | The primary analysis for the trial will occur once all participants have either fulfilled the near FH definition (growth rate of < 2 cm/year and have reached a bone age of 14 years (females) or 16 years (males)), have completed the 36-month assessment or have withdrawn from the study or been lost to follow-up and corre... | PMC10440873 | ||
Health economics analysis | GHD | SECONDARY, GHD | The health economics analysis has two specific aims. The first is to assess the cost-effectiveness of GH discontinuation in the early re-testing scenario by estimating the cost per percentage of children achieving TH of GH − compared to GH + over a 12-month period, and the second is to assess the cost-effectiveness of ... | PMC10440873 |
Reporting guidelines | The SPIRIT reporting guidelines have been used in this publication [ | PMC10440873 | ||
Ethical considerations | RECRUITMENT | In the UK, ethical approval, MHRA approval (Clinical Trial Authorisation), HRA approval and local capacity and capability assessments will be obtained prior to the start of recruitment. In Austria, CTIS ethical approval and BASG approvals (Clinical Trial Authorisation) has been obtained. The study will be conducted in ... | PMC10440873 | |
Reporting of adverse events | ADVERSE EVENTS, RSI | The collection and reporting of adverse events (AEs) will be in accordance with Regulation (EU) No. 536/2014 (Clinical Trial Safety Reporting requirements), the Medicines for Human Use Clinical Trials Regulations (2004) and its subsequent amendments, the UK Policy Framework for Health and Social Care (2017), and the re... | PMC10440873 | |
Auditing | Investigators will permit trial-related monitoring, audits, ethical review, and regulatory inspection(s) at their site, providing direct access to source data/documents. Investigators will comply with these visits and any required follow | PMC10440873 | ||
Protocol amendment communication | Important protocol modifications will be communicated to relevant parties in accordance with BCTU’s quality management system. | PMC10440873 | ||
Dissemination | GHD | SECONDARY, GHD | The GHD Reversal Trial protocol will be made publicly available via both the GHD Reversal Trial webpage hosted by the Trial Office and subsequently published in an appropriate journal, in advance of the final data set. Upon completion of the trial and analysis of the final dataset, a Final Report to the Funder will be ... | PMC10440873 |
Monitoring | PMC10440873 | |||
Trial Steering Committee (TSC) | TSC, GHD | GHD | The TSC for the GHD Reversal Trial will meet at least annually and as required depending on the needs of the trial. The TSC includes members who are independent of the investigators, their employing organisations, funders and sponsors.Membership and duties/responsibilities are outlined in the TSC Charter. In summary, t... | PMC10440873 |
Independent Data Monitoring Committee (DMC) | GHD | ADVERSE EVENTS, RECRUITMENT, GHD | Data analyses will be supplied in confidence to an independent DMC, which will be asked to give advice on whether the accumulated data from the trial, together with the results from other relevant research, justifies the continuing recruitment of further participants. The DMC includes members who are independent of the... | PMC10440873 |
Data access | During the period of the study, only the data monitoring committee (DMC) will have access to the full trial dataset in order to ensure participant safety. Following publication of the findings, an aggregated, anonymised final trial dataset will be made available to external researchers upon approval from the sponsor, t... | PMC10440873 |
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