Sharing clinical trial results with participants: important, expected and possible.

Participants in clinical trials should be pro-actively offered the results of trials in which they have participated. This should be done in a way that is accessible and understandable for all participants. People who have taken part in research have a right to know the results of the studies in which they have taken part and should be given the option of receiving these results.

Development of the intelligent knee osteoarthritis lifestyle app: a person-based approach.

Background: Knee osteoarthritis is one of the most prevalent long term health conditions globally. Exercise and physical activity are now widely recognised to significantly reduce joint pain, improve physical function and quality of life in patients with knee osteoarthritis. However, prescribed exercise without regular contact with a healthcare professional often results in lower adherence and poorer health outcomes.

Influence of the intelligent knee osteoarthritis lifestyle app (iKOALA) on knee joint pain.

Background: The intelligent knee osteoarthritis lifestyle app (iKOALA) has been co-developed with target users to extend the support for physical activity (PA) and musculoskeletal health, beyond short-term structured rehabilitation, using personalised PA guidance, education, and social support. The purpose of this study was to assess the preliminary effectiveness and usability of the iKOALA digital intervention on indices of musculoskeletal (MSK) health, symptoms, and physical activity levels in a broad range of individuals with knee osteoarthritis (KOA) over 12 weeks to inform the design of a larger randomised controlled trial.

Methods: Thirty-eight (33 female) participants living in the UK with a mean (SD) age of 58 (± 9) years diagnosed radiographically or clinically with KOA completed a 12-week user trial of the iKOALA.

The effects of upper- vs. lower-body aerobic exercise on perceived pain in individuals with chronic knee pain: a randomised crossover trial.

Background And Objectives: Some patients with chronic knee pain experience an increase in knee pain following a single bout of exercise involving their knee joint, which can negatively affect exercise adherence and thus result in reduced overall health and lack of disease management. We want to determine whether a single bout of upper-body (UB) aerobic arm-ergometry exercise is effective in reducing the experience of pain in those with chronic knee pain compared with lower-body (LB) aerobic leg ergometry exercise.

Methods: A total of 19 individuals (women = 11, men = 8; age = 63 ± 8 years; body mass index = 24 ± 3 kg/m) who suffered from chronic knee pain for ≥3 months took part in this study.

Effect of novel technology-enabled multidimensional physical activity feedback in primary care patients at risk of chronic disease - the MIPACT study: a randomised controlled trial.

Background: Technological progress has enabled the provision of personalised feedback across multiple dimensions of physical activity that are important for health. Whether this multidimensional approach supports physical activity behaviour change has not yet been examined. Our objective was to examine the effectiveness of a novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support in primary care patients identified as at risk of chronic disease.

Omission of a carbohydrate-rich breakfast impairs evening endurance exercise performance despite complete dietary compensation at lunch.

Omission of a carbohydrate-rich breakfast followed by consuming an lunch impairs evening exercise performance. However, it is unclear if this is due to breakfast omission , or secondary to lower carbohydrate intake over the day. To test whether impaired evening performance following breakfast omission persists when complete dietary compensation occurs at lunch, in a randomised cross-over design, eleven highly trained cyclists (age: 25 ± 7 y, VOmax: 61 ± 5 ml·kg·min) completed two trials: breakfast (B) and no breakfast (NB).

Effect of Plain Versus Sugar-Sweetened Breakfast on Energy Balance and Metabolic Health: A Randomized Crossover Trial.

Objective: This study investigated the effect of 3 weeks of high-sugar ("Sweet") versus low-sugar ("Plain") breakfast on energy balance, metabolic health, and appetite.

Methods: A total of 29 healthy adults (22 women) completed this randomized crossover study. Participants had pre- and postintervention appetite, health, and body mass outcomes measured, and they recorded diet, appetite (visual analogue scales), and physical activity for 8 days during each intervention.

Six Weeks of Morning Fasting Causes Little Adaptation of Metabolic or Appetite Responses to Feeding in Adults with Obesity.

Objective: The aim of this study was to determine the effects of sustained morning fasting or breakfast consumption on metabolism, energy intake, and appetite in healthy adults with obesity.

Methods: An independent-measures randomized controlled trial with baseline and follow-up laboratory assessment days separated by a 6-week intervention of either morning fasting (0 kcal until 12:00 pm) or daily breakfast (> 700 kcal by 11:00 am) was performed. Measures included metabolic outcomes (glucose, insulin, nonesterified fatty acids), hormones regulating appetite (total/acylated ghrelin, peptide YY, leptin), and energy expenditure (diet-induced thermogenesis) parameters throughout a laboratory test day and ad libitum intake following a fixed breakfast.

Postprandial Metabolism and Appetite Do Not Differ between Lean Adults that Eat Breakfast or Morning Fast for 6 Weeks.

Background: It remains unknown whether sustained daily feeding-fasting patterns modify the acute response to specific feedings on a given day.

Objective: We conducted a randomized controlled trial to establish if daily breakfast consumption or fasting until noon modifies the acute metabolic and appetitive responses to a fixed breakfast and ad libitum lunch.

Methods: With the use of a parallel group design, we randomly assigned 31 healthy, lean men and women (22-56 y) to 6 wk of either consuming ≥700 kcal of self-selected items before 1100 or fasting (0 kcal) until 1200 daily.

Molecular adaptations of adipose tissue to 6 weeks of morning fasting vs. daily breakfast consumption in lean and obese adults.

Key Points: In lean individuals, 6 weeks of extended morning fasting increases the expression of genes involved in lipid turnover (ACADM) and insulin signalling (IRS2) in subcutaneous abdominal adipose tissue. In obese individuals, 6 weeks of extended morning fasting increases IRS2 expression in subcutaneous abdominal adipose tissue. The content and activation status of key proteins involved in insulin signalling and glucose transport (GLUT4, Akt1 and Akt2) were unaffected by extended morning fasting.

Assessment of laboratory and daily energy expenditure estimates from consumer multi-sensor physical activity monitors.

Wearable physical activity monitors are growing in popularity and provide the opportunity for large numbers of the public to self-monitor physical activity behaviours. The latest generation of these devices feature multiple sensors, ostensibly similar or even superior to advanced research instruments. However, little is known about the accuracy of their energy expenditure estimates.

Is breakfast the most important meal of the day?

The Bath Breakfast Project is a series of randomised controlled trials exploring the effects of extended morning fasting on energy balance and health. These trials were categorically not designed to answer whether or not breakfast is the most important meal of the day. However, this review will philosophise about the meaning of that question and about what questions we should be asking to better understand the effects of breakfast, before summarising how individual components of energy balance and health respond to breakfast v.

The causal role of breakfast in energy balance and health: a randomized controlled trial in obese adults.

Background: The causal nature of associations between breakfast and health remain unclear in obese individuals.

Objective: We sought to conduct a randomized controlled trial to examine causal links between breakfast habits and components of energy balance in free-living obese humans.

Design: The Bath Breakfast Project is a randomized controlled trial with repeated measures at baseline and follow-up among a cohort in South West England aged 21-60 y with dual-energy X-ray absorptiometry-derived fat mass indexes of ≥13 kg/m(2) for women (n = 15) and ≥9 kg/m(2) for men (n = 8).

Carbohydrate-rich breakfast attenuates glycaemic, insulinaemic and ghrelin response to ad libitum lunch relative to morning fasting in lean adults.

Breakfast omission is associated with obesity and CVD/diabetes, but the acute effects of extended morning fasting upon subsequent energy intake and metabolic/hormonal responses have received less attention. In a randomised cross-over design, thirty-five lean men (n 14) and women (n 21) extended their overnight fast or ingested a typical carbohydrate-rich breakfast in quantities relative to RMR (i.e.

The causal role of breakfast in energy balance and health: a randomized controlled trial in lean adults.

Background: Popular beliefs that breakfast is the most important meal of the day are grounded in cross-sectional observations that link breakfast to health, the causal nature of which remains to be explored under real-life conditions.

Objective: The aim was to conduct a randomized controlled trial examining causal links between breakfast habits and all components of energy balance in free-living humans.

Design: The Bath Breakfast Project is a randomized controlled trial with repeated-measures at baseline and follow-up in a cohort in southwest England aged 21-60 y with dual-energy X-ray absorptiometry-derived fat mass indexes ≤11 kg/m² in women (n = 21) and ≤7.

Bath Breakfast Project (BBP)--examining the role of extended daily fasting in human energy balance and associated health outcomes: study protocol for a randomised controlled trial [ISRCTN31521726].

Background: Current guidance regarding the role of daily breakfast in human health is largely grounded in cross-sectional observations. However, the causal nature of these relationships has not been fully explored and what limited information is emerging from controlled laboratory-based experiments appears inconsistent with much existing data. Further progress in our understanding therefore requires a direct examination of how daily breakfast impacts human health under free-living conditions.