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. Digital mobile health (mHealth) technologies offer great potential to support people with long-term conditions such as knee osteoarthritis more efficiently and effectively and with relatively lower cost than existing interventions. However, there are currently very few mHealth interventions for the self-management of knee osteoarthritis. The aim of the present study was to describe the development process of a mHealth app to extend the support for physical activity and musculoskeletal health beyond short-term, structured rehabilitation through self-management, personalised physical activity, education, and social support. METHODS: The development of the intelligent knee osteoarthritis lifestyle application intervention involved an iterative and interconnected process comprising intervention 'planning' and 'optimisation' informed by the person-based approach framework for the development of digital health interventions. The planning phase involved a literature review and collection of qualitative data obtained from focus groups with individuals with knee osteoarthritis (n = 26) and interviews with relevant physiotherapists (n = 5) to generate 'guiding principles' for the intervention. The optimisation phase involved usability testing (n = 7) and qualitative 'think aloud' sessions (n = 6) with potential beneficiaries to refine the development of the intervention. RESULTS: Key themes that emerged from the qualitative data included the need for educational material, modifying activities to suit individual abilities and preferences as well as the inclusion of key features such as rehabilitation exercises. Following a user-trial further changes were made to improve the usability of the application. CONCLUSIONS: Using a systematic person-based, development approach, we have developed the intelligent knee osteoarthritis lifestyle application to help people maintain physical activity behaviour. The app extends the support for physical activity and musculoskeletal health beyond short-term, structured rehabilitation through personalised physical activity guidance, education, and social support.

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. Participants completed an in-app physical activity questionnaire which intelligently recommended suitable strengthening and aerobic based activities to individuals. Throughout the trial, participants wore a physical activity monitor and were given access to functions within the app (physical activity (PA) reminders, information and education, symptom and PA tracking as well as social support forums) to support them in maintaining their PA plan. Participants completed a MSK questionnaire for chronic symptoms and quality of life (MSK-HQ) as well as an acute iKOALA symptoms questionnaire (confidence, fatigue, mood, pain during the day/night, sleep and ability to walk) in the week prior to starting and following completion of the trial. RESULTS: Physical activity levels were consistent over the 12 weeks with total daily steps of 9102 (± 3514) in week 1, 9576 (± 4214) in week 6 and 9596 (± 3694) in week 12. Group mean changes in all iKOALA MSK symptom scores and the total MSK-HQ (pre 33.1 (7.6) vs. post 40.2 (7.6)) score improved significantly (p < .001, 95% CI [-8.89, -5.16]) over the 12-week period. CONCLUSIONS: Physical activity levels were maintained at a high level throughout the 12 weeks. Significant improvements in mean MSK symptom scores and the total MSK-HQ score were also observed. Efforts to ensure more generalised reach amongst sex and socioeconomic status of the digital intervention in a randomised controlled clinical trial are warranted.

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 ad libitum lunch impairs evening exercise performance. However, it is unclear if this is due to breakfast omission per se, 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, VO2max: 61 ± 5 ml·kg-1·min-1) completed two trials: breakfast (B) and no breakfast (NB). During B, participants consumed an individualised breakfast (583 ± 54 kcal; 8-9am) and lunch (874 ± 80 kcal; 12-2pm), whilst during NB participants fasted until 12pm and then consumed a standardised lunch (1457 ± 134 kcal: 12-2pm). The overall energy (1457 ± 134 kcal) and macronutrient profile (carbohydrate: 81.5 ± 0.4%, fat: 5.8 ± 0.1%, protein: 12.7 ± 0.3%) was identical in both trials, with timing the only difference. Mean power output during a 20 km time trial performed in the evening was ~3% lower in NB compared to B (mean difference [95% CI]: -9.1 [-15.3, -2.9] watts, p < 0.01 for condition main effect). No differences in heart rate, blood glucose or blood lactate concentrations were apparent, but perception of effort appeared to be higher in the early stages of the time trial in NB compared to B despite lower power output. Impaired high-intensity endurance performance in the evening following breakfast omission is related to meal timing rather than carbohydrate intake / availability. Provision of an early morning high-carbohydrate meal should be considered to optimise evening exercise performance.

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. METHODS: MIPACT was a parallel-group, randomised controlled trial that recruited patients at medium (≥10 and < 20%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom. Intervention group participants (n = 120) received personal multidimensional physical activity feedback using a customised digital system and web-app for 3 months plus five health trainer-led sessions. All participants received standardised information regarding physical activity. Control group participants (n = 84) received no further intervention. The primary outcome was device-based assessment of physical activity at 12 months. RESULTS: Mean intervention effects were: moderate-vigorous physical activity: -1.1 (95% CI, - 17.9 to 15.7) min/day; moderate-vigorous physical activity in ≥10-min bouts: 0.2 (- 14.2 to 14.6) min/day; Physical Activity Level (PAL): 0.00 (- 0.036 to 0.054); vigorous physical activity: 1.8 (- 0.8 to 4.2) min/day; and sedentary time: 10 (- 19.3 to 39.3) min/day. For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID). However, there was profound physical activity multidimensionality, and only a small proportion (5%) of patients had consistently low physical activity across all dimensions. CONCLUSION: In patients at risk of cardiovascular disease and/or type II diabetes, MIPACT did not increase mean physical activity. Using a sophisticated multidimensional digital approach revealed enormous heterogeneity in baseline physical activity in primary care patients, and practitioners may need to screen for low physical activity across dimensions rather than rely on disease-risk algorithms that are heavily influenced by age. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry ( ISRCTN18008011 ; registration date 31 July 2013).

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. Interventions were 3 weeks of isoenergetic Sweet (30% by weight added sugar; average 32 g of sugar) versus Plain (no added sugar; average 8 g of sugar) porridge-based breakfasts. RESULTS: Pre- to postintervention changes in body mass were similar between Plain (Δ 0.1 kg; 95% CI: -0.3 to 0.5 kg) and Sweet (Δ 0.2 kg; 95% CI: -0.2 to 0.5 kg), as were pre- to postintervention changes for biomarkers of health (all P ≥ 0.101) and psychological appetite (all P ≥ 0.152). Energy, fat, and protein intake was not statistically different between conditions. Total carbohydrate intake was higher during Sweet (287 ± 82 g/d vs. 256 ± 73 g/d; P = 0.009), driven more by higher sugar intake at breakfast (116 ± 46 g/d vs. 88 ± 38 g/d; P < 0.001) than post-breakfast sugar intake (Sweet 84 ± 42 g/d vs. Plain 80 ± 37 g/d; P = 0.552). Participants reported reduced sweet desire immediately after Sweet but not Plain breakfasts (trial × time P < 0.001). CONCLUSIONS: Energy balance, health markers, and appetite did not respond differently to 3 weeks of high- or low-sugar breakfasts.

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. RESULTS: Allocation to fasting versus breakfast resulted in minimal adaptation as reflected by the metabolic outcomes or the majority of appetite regulatory outcomes for either area under curve or time-course-based measures (P > 0.05). Ad libitum lunch intake was not different (P = 0.13), nor was diet-induced thermogenesis or a composite appetite score (both P > 0.10). However, there was a reduced total area under the curve for peptide YY (P = 0.05) and increased postprandial hunger ratings (P = 0.05) in the breakfast group. CONCLUSIONS: There was little evidence of metabolic adaptation to acute feeding or negative consequences from sustained morning fasting. This indicates that previously observed differences between breakfast consumers and skippers may be acute effects of feeding or may have resulted from other lifestyle factors.

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. Following 48 h of diet and physical activity standardization, we examined metabolic and appetite responses to a standardized breakfast and ad libitum lunch before and after the intervention. Data were analyzed using 3- and 2-way ANCOVA. Results: Systemic concentrations of energy balance regulatory hormones total and acylated ghrelin, leptin, and peptide tyrosine-tyrosine) responded similarly to breakfast and lunch before and after 6 wk of either morning fasting or regular breakfast, with the exception of a tendency for increased glucagon-like peptide-1 concentrations from baseline to follow-up in the Breakfast Group compared with a decrease over that period in the Fasting Group [P = 0.06, partial eta squared value (ƞ2) = 0.16]. Subjective appetite sensations also did not differ over the course of the day, and ad libitum energy intake at lunch was not systematically affected by either intervention, decreasing by 27 kcal (95% CI: -203, 149 kcal) with fasting and by 77 kcal (95% CI: -210, 56 kcal) with breakfast. Similarly, glycemic, insulinemic, lipemic, and thermogenic responses to breakfast and lunch were very stable at baseline and follow-up and, thus, did not differ between treatment groups. Conclusions: Our results indicate that a sustained period of either extended morning fasting or eating a daily breakfast has minimal effect upon acute metabolic and appetite responses in lean adults. This trial was registered at www.isrctn.org as ISRCTN31521726.

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. Therefore, any observations of altered adipose tissue insulin sensitivity with extended morning fasting do not necessarily require changes in insulin signalling proximal to Akt. Insulin-stimulated adipose tissue glucose uptake rates are lower in obese versus lean individuals, but this difference is abolished when values are normalised to whole-body fat mass. This suggests a novel hypothesis which proposes that the reduced adipose glucose uptake in obesity is a physiological down-regulation to prevent excessive de novo lipogenesis. ABSTRACT: This study assessed molecular responses of human subcutaneous abdominal adipose tissue (SCAT) to 6 weeks of morning fasting. Forty-nine healthy lean (n = 29) and obese (n = 20) adults provided SCAT biopsies before and after 6 weeks of morning fasting (FAST; 0 kcal until 12.00 h) or daily breakfast consumption (BFAST; ≥700 kcal before 11.00 h). Biopsies were analysed for mRNA levels of selected genes, and GLUT4 and Akt protein content. Basal and insulin-stimulated Akt activation and tissue glucose uptake rates were also determined. In lean individuals, lipid turnover and insulin signalling genes (ACADM and IRS2) were up-regulated with FAST versus BFAST (ACADM: 1.14 (95% CI: 0.97-1.30) versus 0.80 (95% CI: 0.64-0.96), P = 0.007; IRS2: 1.75 (95% CI: 1.33-2.16) versus 1.09 (95% CI: 0.67-1.51), P = 0.03, respectively). In obese individuals, no differential (FAST versus BFAST) expression was observed in genes involved in lipid turnover (all P > 0.1). GLUT4, Akt protein content and insulin-stimulated Akt phosphorylation were unaffected by FAST versus BFAST in both lean and obese cohorts (all P > 0.1). Lower insulin-stimulated glucose uptake rates in obese versus lean individuals were eradicated when normalised to whole-body fat mass (P = 0.416). We conclude that morning fasting up-regulates lipid turnover genes in SCAT of lean individuals. Secondly, altered SCAT insulin sensitivity with morning fasting is unlikely to be explained by signalling proximal to Akt. Finally, lower insulin-stimulated SCAT glucose uptake rates in obese individuals are proportional to whole-body fat mass, suggesting a compensatory down-regulation, presumably to prevent excessive de novo lipogenesis in adipose tissue. This trial was registered as ISRCTN31521726.

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. Here, we assessed their performance against criterion measurements in both controlled laboratory conditions (simulated activities of daily living and structured exercise) and over a 24 hour period in free-living conditions. Thirty men (n = 15) and women (n = 15) wore three multi-sensor consumer monitors (Microsoft Band, Apple Watch and Fitbit Charge HR), an accelerometry-only device as a comparison (Jawbone UP24) and validated research-grade multi-sensor devices (BodyMedia Core and individually calibrated Actiheart™). During discrete laboratory activities when compared against indirect calorimetry, the Apple Watch performed similarly to criterion measures. The Fitbit Charge HR was less consistent at measurement of discrete activities, but produced similar free-living estimates to the Apple Watch. Both these devices underestimated free-living energy expenditure (-394 kcal/d and -405 kcal/d, respectively; P<0.01). The multi-sensor Microsoft Band and accelerometry-only Jawbone UP24 devices underestimated most laboratory activities and substantially underestimated free-living expenditure (-1128 kcal/d and -998 kcal/d, respectively; P<0.01). None of the consumer devices were deemed equivalent to the reference method for daily energy expenditure. For all devices, there was a tendency for negative bias with greater daily energy expenditure. No consumer monitors performed as well as the research-grade devices although in some (but not all) cases, estimates were close to criterion measurements. Thus, whilst industry-led innovation has improved the accuracy of consumer monitors, these devices are not yet equivalent to the best research-grade devices or indeed equivalent to each other. We propose independent quality standards and/or accuracy ratings for consumer devices are required.

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. fasting in lean and obese adults. Current evidence does not support a clear effect of regularly consuming or skipping breakfast on body mass/composition, metabolic rate or diet-induced thermogenesis. Findings regarding energy intake are variable, although the balance of evidence indicates some degree of compensatory feeding later in the day such that overall energy intake is either unaffected or slightly lower when breakfast is omitted from the diet. However, even if net energy intake is reduced, extended morning fasting may not result in expected weight loss due to compensatory adjustments in physical activity thermogenesis. Specifically, we report that both lean and obese adults expended less energy during the morning when remaining in the fasted state than when consuming a prescribed breakfast. Further research is required to examine whether particular health markers may be responsive to breakfast-induced responses of individual components of energy balance irrespective of their net effect on energy balance and therefore body mass.

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). Components of energy balance (resting metabolic rate, physical activity thermogenesis, diet-induced thermogenesis, and energy intake) were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (e.g., hematology/adipose biopsies). RESULTS: Breakfast resulted in greater physical activity thermogenesis during the morning than when fasting during that period (difference: 188 kcal/d; 95% CI: 40, 335) but without any consistent effect on 24-h physical activity thermogenesis (difference: 272 kcal/d; 95% CI: -254, 798). Energy intake was not significantly greater with breakfast than fasting (difference: 338 kcal/d; 95% CI: -313, 988). Body mass increased across both groups over time but with no treatment effects on body composition or any change in resting metabolic rate (stable within 8 kcal/d). Metabolic/cardiovascular health also did not respond to treatments, except for a reduced insulinemic response to an oral-glucose-tolerance test over time with daily breakfast relative to an increase with daily fasting (P = 0.05). CONCLUSIONS: In obese adults, daily breakfast leads to greater physical activity during the morning, whereas morning fasting results in partial dietary compensation (i.e., greater energy intake) later in the day. There were no differences between groups in weight change and most health outcomes, but insulin sensitivity increased with breakfast relative to fasting. This trial was registered at www.isrctn.org as ISRCTN31521726.

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. 1963 (sd 238) kJ), before an ad libitum lunch 3 h later. Blood samples were obtained hourly throughout the day until 3 h post-lunch, with subjective appetite measures assessed. Lunch intake was greater following extended fasting (640 (sd 1042) kJ, P< 0.01) but incompletely compensated for the omitted breakfast, with total intake lower than the breakfast trial (3887 (sd 1326) v. 5213 (sd 1590) kJ, P< 0.001). Systemic concentrations of peptide tyrosine-tyrosine and leptin were greater during the afternoon following breakfast (both P< 0.05) but neither acylated/total ghrelin concentrations were suppressed by the ad libitum lunch in the breakfast trial, remaining greater than the morning fasting trial throughout the afternoon (all P< 0.05). Insulin concentrations were greater during the afternoon in the morning fasting trial (all P< 0.01). There were no differences between trials in subjective appetite during the afternoon. In conclusion, morning fasting caused incomplete energy compensation at an ad libitum lunch. Breakfast increased some anorectic hormones during the afternoon but paradoxically abolished ghrelin suppression by the second meal. Extending morning fasting until lunch altered subsequent metabolic and hormonal responses but without greater appetite during the afternoon. The present study clarifies the impact of acute breakfast omission and adds novel insights into second-meal metabolism.

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 ≤7.5 kg/m² in men (n = 12). Components of energy balance (resting metabolic rate, physical activity thermogenesis, energy intake) and 24-h glycemic responses were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (eg, hematology/biopsies). RESULTS: Contrary to popular belief, there was no metabolic adaptation to breakfast (eg, resting metabolic rate stable within 11 kcal/d), with limited subsequent suppression of appetite (energy intake remained 539 kcal/d greater than after fasting; 95% CI: 157, 920 kcal/d). Rather, physical activity thermogenesis was markedly higher with breakfast than with fasting (442 kcal/d; 95% CI: 34, 851 kcal/d). Body mass and adiposity did not differ between treatments at baseline or follow-up and neither did adipose tissue glucose uptake or systemic indexes of cardiovascular health. Continuously measured glycemia was more variable during the afternoon and evening with fasting than with breakfast by the final week of the intervention (CV: 3.9%; 95% CI: 0.1%, 7.8%). CONCLUSIONS: Daily breakfast is causally linked to higher physical activity thermogenesis in lean adults, with greater overall dietary energy intake but no change in resting metabolism. Cardiovascular health indexes were unaffected by either of the treatments, but breakfast maintained more stable afternoon and evening glycemia than did fasting.

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. METHODS/DESIGN: The Bath Breakfast Project (BBP) is a randomised controlled trial comparing the effects of daily breakfast consumption relative to extended fasting on energy balance and human health. Approximately 70 men and women will undergo extensive laboratory-based assessments of their acute metabolic responses under fasted and post-prandial conditions, to include: resting metabolic rate, substrate oxidation, dietary-induced thermogenesis and systemic concentrations of key metabolites/hormones. Physiological and psychological indices of appetite will also be monitored both over the first few hours of the day (i.e. whether fed or fasted) and also following a standardised test lunch used to assess voluntary energy intake under controlled conditions. Baseline measurements of participants' anthropometric characteristics (e.g. DEXA) will be recorded prior to intervention, along with an oral glucose tolerance test and acquisition of adipose tissue samples to determine expression of key genes and estimates of tissue-specific insulin action. Participants will then be randomly assigned either to a group prescribed an energy intake of ≥3000 kJ before 1100 each day or a group to extend their overnight fast by abstaining from ingestion of energy-providing nutrients until 1200 each day, with all laboratory-based measurements followed-up 6 weeks later. Free-living assessments of energy intake (via direct weighed food diaries) and energy expenditure (via combined heart-rate/accelerometry) will be made during the first and last week of intervention, with continuous glucose monitors worn both to document chronic glycaemic responses to the intervention and to verify compliance.