NIHRDataInsights/HRCSData huggingface dataset:
Title: A randomised controlled trial evaluating the effectiveness and cost-effectiveness of Families for Health a family-based childhood obesity management intervention delivered in a community setting for ages 7 to 11
Funder: Department of Health (England)

Abstract: AimTo assess the effectiveness and cost-effectiveness of the Families for Health programme in the treatment of overweight and obesity in 7-11 year olds compared with usual care.DesignA randomised controlled trial with economic analysis with 12-month follow-up. A mixed-methods process evaluation will be carried out. 120 families randomly allocated to two arms: ‘Families for Health’ (60 families); control group receiving ‘usual care’ (60 families).SettingThree Primary Care Trusts within the West Midlands.PopulationFamilies with at least one child aged 7-11 years who is overweight (> 91st centile for BMI) or obese (>98th centile). Randomisation will be stratified for the three sites.Intervention‘Families for Health’ is a family-based community intervention aimed at children aged 7-11yrs who are overweight or obese. It is a 10 week group-based programme for children and parents with follow up sessions at 1 and 3 months. In addition to focusing on healthy eating and activity it is designed to develop parenting skills. Four trained facilitators run the programme from manuals. Outcome measuresPrimary outcome measure: Change in children’s BMI z-score after 12 month follow-up.Secondary outcome measures: Change in children’s waist circumference; % body fat; physical activity; fruit and vegetable consumption; quality of life; and health state. Change in parents’ BMI mental well-being and health state family eating and activity; parent-child relationships; and parenting style.Economic evaluationIncremental cost per quality-adjusted life year gained will be estimated using responses to the EuroQol health state valuations and costs to run and attend the programme. A de novo decision-analytic model will estimate the lifetime clinical and economic consequences of ‘Families for Health’.Process evaluationRecruitment methods attendance and drop out rates and programme fidelity will be assessed. Interviews of 24 intervention group parents and children will investigate perceptions of ‘Families for Health’.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Establishing a healthy growth trajectory from birth: The Baby Milk Trial
Funder: Medical Research Council

Abstract: Data from the National Child Measurement Programme show that in England, by the time children start school, 13% are overweight and a further 10% are obese. Infancy is a period of rapid growth, developmental plasticity and habit formation; hence could be a critical period when obesity prevention may be most effective. Current UK formula-milk feeding instructions are based on 1985 World Health Organisation (WHO) recommendations. In 2004, based on new data on energy expenditure in infants, the WHO suggested that 1985 recommendations overestimated infant energy requirements. The WHO 2004 recommendations have been endorsed by the UK Scientific Committee for Nutrition in their draft Energy Report. Since the instructions on the formula-milk tins are based on the old 1985 recommendations for energy requirements, this may contribute to excess weight gain in formula-milk fed infants. We aim to evaluate the cost-effectiveness and acceptability of a theory-based behavioural intervention to avoid excess formula-milk intake and to prevent rapid weight gain during infancy. Guided by the MRC framework for complex interventions, our multi-disciplinary group have used an iterative process to optimise the proposed intervention and its evaluation. We will recruit 700 mothers who introduce formula-milk feeds within six weeks of their baby's birth into a randomised controlled trial. The intervention group will receive the behavioural intervention delivered by trained and quality-assured facilitators over six months through 3 face-to-face contacts, 2 telephone contacts and written materials. The control group will have the same number of contacts with facilitators and general issues about feeding will be discussed. The primary outcome is change in weight standard deviation score from birth to 1 year. Secondary objectives are to quantify the effects of the intervention on infant energy intake and diet at age 8 months and changes in infant adiposity during the first year of life.


Research activity codes: 3.3 NUTRITION AND CHEMOPREVENTION
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: MRC Contribution to drINC
Funder: Medical Research Council

Abstract: Diet and Health Research Industry Club (drINC) drINC is a 5-year partnership between BSRC and a consortium of leading companies, aimed at helping the food industry develop products that deliver enhanced health benefits for consumers. Its themes are: Improved understanding of healthier diets - includes effect of food components on energy intake, and how foods might be designed to have precise nutritional properties. Bioactives in foods - includes understanding of how beneficial compounds work and how health claims may be verified. The MRC is contributing to this funding scheme to support a number of projects directly relevant to the MRC's remit.


Research activity codes: 2.2 FACTORS RELATING TO PHYSICAL ENVIRONMENT;3.3 NUTRITION AND CHEMOPREVENTION
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Physical activity in workplace
Funder: Medical Research Council

Abstract: 61% of men and 71% of women in the UK do not meet physical activity (PA) guidelines. Workplaces offer potentially large target populations for much-needed public health interventions aimed at increasing levels of PA, and such interventions have the further potential benefit of reducing long spells of sitting among employees at work. Although targeted group-based walking and exercise interventions have had moderate success in many settings, there are often significant problems with recruitment and retention. One innovative solution in the workplace is to provide opportunities for PA during paid working hours. Some studies have explored this approach in Scandinavia and the US (Conn et al, Am J Prev Med 2009), but no definitive trials have been conducted and none in the UK. At present, employees’ and employers’ views and attitudes towards PA in paid working hours are unknown. Without this fundamental information, and an idea of the potential barriers associated with it, we cannot proceed with intervention development. We therefore propose an early phase study to explore the perceived acceptability of such an incentivised intervention at an employee and organisational level, and to identify barriers that would need to be addressed before such an intervention could be piloted in the UK. We have identified two large workplaces in Forth Valley, Scotland, and would use qualitative methods (focus groups and interviews) to explore the views of stakeholders (employees, line managers and senior managers) on the delivery of opportunities for PA during paid working hours and the kinds of models/sessions they are most likely to engage with, and are implementable. This formative work would be underpinned by a social marketing framework. We would also hold a participative workshop for stakeholders within each workplace to generate ideas for overcoming perceived barriers and logistical difficulties in intervention implementation.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Diet and Obesity Research
Funder: Medical Research Council

Abstract: This research aims to reduce the escalating burden of obesity and hence related diseases by an improved understanding of the role of dietary factors in the prevention and treatment of obesity and the translation of this evidence into policy and practice. Obesity is a major public health problem. National surveys show that the prevalence has trebled in 30 years and today 1 in 4 adults are obese and 1 in 3 children are overweight. Through its links to ill-health, obesity places a substantial burden on individuals, the NHS and the wider economy through lost productivity. Tackling obesity is a key government health priority. Our research falls into three complementary areas: a) Observational studies – To understand the link between specific dietary factors and the control of body weight and related metabolic risk, principally through the analysis of data from prospective cohorts based on empirical dietary patterns. Food purchasing is an important modifiable behavior and we are also analyzing the nutritional content of household food purchases and the influence of promotional activities to identify interventions to prompt healthier food purchases. b) Intervention studies – This includes a series of novel behavioural interventions to influence both individual consumption and food purchasing habits as well as more classical, controlled dietary intervention studies to test the impact of specific food/nutrient manipulations. Through a series of more pragmatic, community-based RCTs we are exploring how to deliver dietary interventions for the treatment of obesity in primary care. This includes testing the effectiveness of brief interventions by healthcare professionals, using web-based behavioural counselling and referral to commercial providers, with parallel studies to examine cost effectiveness and, using qualitative research methods, to explore the experiences of health professionals and participants. c) Evidence synthesis and translation – Independent and authoritative evidence synthesis is crucial to present evidence on the prevention and treatment of obesity to decision makers. We are conducting a series of systematic reviews of the literature relating to diet and obesity in areas of particular policy interest and to put our own research into a wider context. Through formal links with the Department of Health and participation in scientific advisory committees, we translate research findings to policy makers, health practitioners, industry and others to inform public health policy and practice. This research is linked to work in the Behaviour and Health Research Unit (BHRU) and the Centre for Diet and Activity Research (CEDAR) and part of the Cambridge Institute for Public Health (CIPH).


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;2.3 PSYCHOLOGICAL, SOCIAL AND ECONOMIC FACTORS;8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Genetic aetiology of obesity
Funder: Medical Research Council

Abstract: The prevalence of obesity and overweight continues to increase steadily. Although changes in lifestyle are driving this epidemic, not all people become obese. This observation highlights that obesity is a common multifactorial condition that arises through the joint actions of genes and environment. |The aims of this programme are to use epidemiological methods; |[1] to identify genetic variants associated with obesity and related traits through two main approaches; [a] a hypothesis generating approach by GWA studies, and [b] a hypothesis-driven approach by candidate gene studies, and |[2] to determine the mode of action of the newly identified and established obesity-susceptibility loci, [a] by examining traits intermediate to obesity, and [b] by examining the role of the obesity-susceptibility loci in the development of diseases or traits presumed to result from obesity through Mendelian randomisation studies, and|[3] to identify how obesity-susceptibility genes interact with lifestyle factors such as physical activity and diet through gene-environment interaction studies.|The main approach applied in this programme is genome-wide association, a hypothesis-generating approach that aims to discover novel genetic variants that predispose to a disease or a trait. Over the past three years, this programme has contributed to the discovery of nine established obesity-susceptibility loci by leading the analyses of three waves of genome-wide association studies. We are currently leading the fourth wave of genome-wide association studies as part of the GIANT consortium including data on more than 126,000 individuals which promises to identify more obesity-susceptibility loci. Besides testing for association with BMI, we also examine associations with more refined obesity-related traits and with traits intermediate to the development of obesity..|We will continue to identify obesity-susceptibility genes through large-scale meta-analyses of candidate genes variants. Candidate gene studies aim to validate observations from animal models or extreme case studies at the population level. Therefore, our collaboration with colleagues at the MRC CORD and WT Sanger Institute is crucial as they will be the primary source for novel physiological insights.|This programme also studies how obesity-susceptibility genes interact with lifestyle factors such as physical activity and diet. We will examine whether the GWA-identified obesity-susceptibility variants as well as the established candidate genes (based on physiology) interact with lifestyle factors.|By studying the genetics of obesity, we aim to gain insight in the complex physiology that governs the regulation of energy balance. Translation of these new findings into clinical practice will require collaboration with basic, translational and clinical scientists.


Research activity codes: 2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Metabolic and Molecular Imaging
Funder: Medical Research Council

Abstract: Our group has established a multidisciplinary programme that integrates biochemical, molecular biology and MRI/MRS techniques for translational science that goes from molecular events to clinically relevant end-points. We have identified genetic and environmental factors that modulate adipose tissue distribution and function and its impact on insulin sensitivity. We have also demonstrated the importance of early-life events and ethnicity on later-life body adiposity. Furthermore, using comprehensive pre-clinical and clinical phenotypic studies, coupled to cellular and molecular biology, we have shown the role of hypothalamic and rewards centres play in modulating food intake and hence body adiposity.|Within this framework we are now aim to explore:||(1) The effects of regional fat distribution (visceral, subcutaneous, liver and muscle) on metabolic risk and biomarkers in obesity and diabetes, and their response to therapy.||(2) The brain pathways by which appetite is altered in obesity, by gut hormones and anti-obesity therapies using pre-clinical manganese-enhanced MRI and clinical BOLD fMRI with a particular focus on hypothalamic, brainstem and reward systems||(3) The influence(s) of specific environmental factors such as diet and exercise, and candidate genes on these physiological processes, particularly those associated with appetite, adipose tissue metabolism and function.|


Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Action330: Promoting children's physical activity via enhanced after-school leadership
Funder: Medical Research Council

Abstract: The project includes both formative research and then a feasibility trial. A summary of the research methods that will be used in each phase is outlined below. Formative research: Phases 1 and 2 will involve interviews with Teaching Assistants, teacher trainers and parents along with focus groups with Year 5/6 students. All interviews and focus groups will be digitally recorded, transcribed verbatim and the transcripts verified. All transcripts will be thematically analysed. Feasibility trial: Phase 4 of the project will be a feasibility trial in which 600, Year 5 and 6 students are recruited from 20 primary schools. Half of the schools will be randomly allocated to the intervention arm with the remaining schools allocated to the control arm. Schools will be stratified according to school district and the school tax credit information. Two Teaching Assistants in each intervention school will attend a 5-day training programme that will focus on developing their physical activity management skills. Teaching Assistants will also be provided with 36 session plans. Teaching Assistants will deliver the new programme for 18-weeks in intervention schools. Children in control schools will participate in data collection only. Students in intervention and control schools will provide data at baseline (time 0), in the middle of the intervention (time 0+9 weeks), at the end of the intervention period (time 0 + 18 weeks) and 4-months after the intervention has ended (time 0+36 weeks). The primary outcome will be accelerometer determined minutes of MVPA per day. Participants will also complete questionnaires to assess change in scores on psychosocial constructs. Analyses will mainly be descriptive in nature and will include means (SD) or N (%) as appropriate. Between group comparisons will be made using appropriate regression models, but with the focus on 95% confidence intervals in order to estimate possible effect sizes. P-values will not be considered.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: FLICC (Front of pack food Labelling: Impact on Consumer Choice)
Funder: Medical Research Council

Abstract: Front of pack (FOP) nutrition labels are displayed on most foods available in UK supermarkets but little is known about how they are used in real-life shopping situations, or whether their influence can be amplified to encourage healthier food purchases. This project involves three phases. Phase 1 is secondary analyses of two studies where researchers accompanied shoppers and observed behaviour. The analyses will focus on the influence of FOP labels. Phase 2 is a qualitative study of use of FOP labels in shopping situations using innovative data collection techniques. 30 participants will conduct a routine shop wearing SenseCam (a wearable camera which automatically takes photos from a first-person viewpoint at a standard interval), and 30 participants will conduct both a routine shop and a 'healthy shopping' task whilst wearing SenseCam. The images will be used to prompt recall in a semi-structured interview conducted immediately after the shop. Participants will be asked about two interventions to amplify the impact of FOP labels (I1) tailored feedback promoting foods with healthier FOP labels than previous purchases, (I2) a web-based education programme about FOP labels. Phase 3 is a pilot RCT of the effectiveness of I1 and I2. The pilot RCT will be conducted in Co-op supermarkets nationwide. 400 participants will be randomised to four arms: control; I1; I2; I1 and I2. Data collection will take place over 12 weeks, during which time electronic sales data from the participants will be automatically delivered to researchers. I1 and I2 will be delivered during weeks 5-8. Final outcome measure will be average healthiness of foods purchased during weeks 5-8 compared to weeks 1-4, and between weeks 9-12 compared to weeks 1-4. Data on these final outcome measures will be used to inform power calculations for a full RCT. A process evaluation involving telephone interviews with Co-op staff and study participants will be conducted to assess the feasibility of a full RCT.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL
Title: Reducing sedentary behaviour in older adults: Development of a brief habit-based intervention
Funder: Medical Research Council

Abstract: This study aims to develop a theory-based intervention to promote the formation of physical activity 'habits' among sedentary older adults. The proposed work is cross-disciplinary and covers 'Development' and 'Feasibility/Piloting' stages of intervention design stipulated by MRC guidance. Study 1 is designed to develop a series of recommendations for simple 'activity habits', using consensus methods (focus groups, nominal groups, and a Delphi process) among panels of users and experts. Qualitative data will be analysed using thematic and content analysis. Study 2 will assess the feasibility of the recommendations among a group of 30 sedentary older adults, using a pre-post design with measures at baseline, 4 and 8 week follow-up. Analysis will focus on recruitment, adherence, attrition, and favourability of the intervention. Quantitative data relating to self-reported 'habit' formation, activity and health will be analysed using t-tests. Semi-structured interviews conducted at the end of the intervention period will be evaluated using thematic and content analysis. Study 3 will use an exploratory controlled trial design to pilot the 'habit' formation intervention relative to a control treatment which does not use 'habit' formation principles, and assess the feasibility of recruiting to such a trial. 120 sedentary older adults will be allocated to intervention or control in blocks, and will be followed up at 8 and 12 weeks. Analysis will focus on rates of recruitment, adherence and attrition, and changes in self-reported habit, and self-reported and objective measures of behaviour, physical health and wellbeing. Completer analysis and intention-to-treat analysis will be undertaken using ANCOVAs. The study will generate an intervention suitable for full testing using a randomised controlled trial design. Findings will be disseminated to the lay public via press releases, and to the scientific community via journal publications and conferences.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;METABOLIC AND ENDOCRINE;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL