How people wake up is associated with previous night's sleep together with physical activity and food intake.

How people wake up and regain alertness in the hours after sleep is related to how they are sleeping, eating, and exercising. Here, in a prospective longitudinal study of 833 twins and genetically unrelated adults, we demonstrate that how effectively an individual awakens in the hours following sleep is not associated with their genetics, but instead, four independent factors: sleep quantity/quality the night before, physical activity the day prior, a breakfast rich in carbohydrate, and a lower blood glucose response following breakfast. Furthermore, an individual's set-point of daily alertness is related to the quality of their sleep, their positive emotional state, and their age. Together, these findings reveal a set of non-genetic (i.e., not fixed) factors associated with daily alertness that are modifiable.

Menopause is associated with postprandial metabolism, metabolic health and lifestyle: The ZOE PREDICT study.

BACKGROUND: The menopause transition is associated with unfavourable alterations in health. However, postprandial metabolic changes and their mediating factors are poorly understood. METHODS: The PREDICT 1 UK cohort (n=1002; pre- n=366, peri- n=55, and post-menopausal females n=206) assessed phenotypic characteristics, anthropometric, diet and gut microbiome data, and fasting and postprandial (0-6 h) cardiometabolic blood measurements, including continuous glucose monitoring (CGM) data. Differences between menopausal groups were assessed in the cohort and in an age-matched subgroup, adjusting for age, BMI, menopausal hormone therapy (MHT) use, and smoking status. FINDINGS: Post-menopausal females had higher fasting blood measures (glucose, HbA1c and inflammation (GlycA), 6%, 5% and 4% respectively), sugar intakes (12%) and poorer sleep (12%) compared with pre-menopausal females (p<0.05 for all). Postprandial metabolic responses for glucose2hiauc and insulin2hiauc were higher (42% and 4% respectively) and CGM measures (glycaemic variability and time in range) were unfavourable post- versus pre-menopause (p<0.05 for all). In age-matched subgroups (n=150), postprandial glucose responses remained higher post-menopause (peak0-2h 4%). MHT was associated with favourable visceral fat, fasting (glucose and insulin) and postprandial (triglyceride6hiauc) measures. Mediation analysis showed that associations between menopause and metabolic health indicators (visceral fat, GlycA360mins and glycaemia (peak0-2h)) were in part mediated by diet and gut bacterial species. INTERPRETATION: Findings from this large scale, in-depth nutrition metabolic study of menopause, support the importance of monitoring risk factors for type-2 diabetes and cardiovascular disease in mid-life to older women to reduce morbidity and mortality associated with oestrogen decline. FUNDING: Zoe Ltd.

The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention.

The Breast Cancer Weight Loss (BWEL) trial is a randomized controlled trial designed to determine whether weight loss after a breast cancer diagnosis can reduce the risk of cancer recurrence in women with overweight or obesity. The BWEL trial will compare the efficacy of a telephone-based weight-loss intervention plus health education materials versus health education materials alone on invasive disease-free survival in 3,181 women with stage II or III breast cancer and BMI > 27 kg/m2 . This report provides a detailed description of the goals and methods of the lifestyle intervention and the evidence supporting the intervention used in the BWEL trial. The intervention's primary goal for participants is to achieve and maintain a weight loss ≥ 10% of baseline weight through increased physical activity and caloric restriction. The evidence supporting the diet, physical activity, and behavioral components of this telephone-based weight-loss intervention, as well as strategies to promote participant engagement and retention, is described. The intervention is provided through 42 sessions delivered by trained health coaches over a 2-year period. If the BWEL lifestyle intervention is successful in improving cancer outcomes, then weight loss will be incorporated into the care of thousands of breast cancer patients.

Barriers to Weight Loss and Physical Activity, and Coach Approaches to Addressing Barriers, in a Real-World Adaptation of the DPP Lifestyle Intervention: A Process Analysis.

PURPOSE: The purpose of this study is to identify barriers to weight loss and physical activity, as well as approaches used by coaches, in a real-world, community sample of adults with metabolic syndrome (at risk for type 2 diabetes) who participated in a Diabetes Prevention Program (DPP)-adapted weight loss intervention and compare findings to data from the screened and highly selected DPP sample. METHODS: SHINE (Support, Health Information, Nutrition, and Exercise) was a telephonic DPP adaptation. Primary care staff delivered the DPP curriculum, and lifestyle coaches provided monthly direction to achieve weight loss. For this substudy, barriers to weight loss and physical activity described by participants, as well as approaches coaches used to address them, were gathered. Groupings of barriers (DPP defined) were analyzed in relation to demographic characteristics and compared to data from the DPP sample. RESULTS: Top weight loss barriers were problems with self-monitoring, too little physical activity, internal thought/mood cues, vacation/holidays, and social cues. Percentages reporting a barrier were much higher in SHINE. Top physical activity barriers were problems with self-monitoring, access/weather, time management, aches/pains, and vacation/holidays. These did not correspond closely to DPP data. Coaches used problem solving, self-monitoring skills review, increased physical activity, and motivational strategies. SHINE coaches were more likely than DPP coaches to use alternative approaches. CONCLUSIONS: Barriers to weight loss and physical activity in a community sample of persons at risk for diabetes occurred at much higher rates than in the highly screened DPP sample. Training coaches in a variety of patient-centered approaches may maximize their positive impact.

Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study.

Background: Lifestyle interventions have been shown to improve physical function over the short term; however, whether these benefits are sustainable is unknown. The long-term effects of an intensive lifestyle intervention (ILI) on physical function were assessed using a randomized post-test design in the Look AHEAD trial. Methods: Overweight and obese (body mass index ≥ 25 kg/m2) middle-aged and older adults (aged 45-76 years at enrollment) with type 2 diabetes enrolled in Look AHEAD, a trial evaluating an ILI designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including a 4- and 400-m walk, lower extremity physical performance (expanded Short Physical Performance Battery, SPPBexp), and grip strength approximately 11 years postrandomization and 1.5 years after the intervention was stopped (n = 3,783). Results: Individuals randomized to ILI had lower odds of slow gait speed (<0.8 m/s) compared to those randomized to DSE (adjusted OR [95% CI]: 0.84 [0.71 to 0.99]). Individuals randomized to ILI also had faster gait speed over 4- and 400-m (adjusted mean difference [95% CI]: 0.019 [0.007 to 0.031] m/s, p = .002, and 0.023 [0.012 to 0.034] m/sec, p < .0001, respectively) and higher SPPBexp scores (0.037 [0.011 to 0.063], p = .005) compared to those randomized to DSE. The intervention effect was slightly larger for SPPBexp scores among older versus younger participants (0.081 [0.038 to 0.124] vs 0.013 [-0.021 to 0.047], p = .01). Conclusions: An intensive lifestyle intervention has modest but significant long-term benefits on physical function in overweight and obese middle-aged and older adults with type 2 diabetes. ClinicalTrials.gov Identifier: NCT00017953.

Weight loss in the prevention and treatment of diabetes.

The American Diabetes Association nutrition and lifestyle recommendations for prediabetes and type 2 diabetes focus on losing 7% of body weight and increasing physical activity to at least 150minperweek. This emphasis is largely based on results of the Diabetes Prevention Program (DPP) and Look AHEAD (Action for Health in Diabetes) clinical trials. DPP demonstrated that a lifestyle intervention aimed at 7% weight loss and 150min of activity per week reduced diabetes incidence by 58% after 2.8years of follow-up and resulted in sustained improvements in hemoglobinA1c, blood pressure and lipid levels. After 15years of follow-up, DPP's lifestyle intervention sustained a 27% risk reduction in progression to diabetes. Look AHEAD's lifestyle intervention significantly reduced hemoglobinA1c, blood pressure, triglycerides, and the amount and costs of medications needed to treat these conditions when compared with diabetes support and education. Other clinical and psychological benefits achieved with lifestyle intervention were greater reductions in c-reactive protein, less self-reported retinopathy, reduced risk of nephropathy, less sexual dysfunction, decreased incidence of urinary incontinence and fatty liver, remission of sleep apnea, better physical functioning, less knee pain, more remission of diabetes, reduced incidence of depression, less body image dissatisfaction and improved quality-of-life. A number of DPP translation studies have demonstrated weight losses of 4 to 7% at 6month and 1year follow-up which has led to Medicare coverage for CDC recognized DPP lifestyle programs starting in April 2018. Translation studies of Look AHEAD using a variety of delivery formats are underway.

Improving diabetes outcomes through lifestyle change--A randomized controlled trial.

OBJECTIVE: To compare a diabetes group lifestyle intervention (GLI) with dietitian referral for medical nutrition therapy (RD) for weight loss in the usual care setting. METHODS: Randomized clinical trial was conducted with 57 primary care patients with type 2 diabetes and body mass index (BMI) >25 kg/m(2) who received either a dietitian-led 19-week GLI adapted from the Look AHEAD study or RD. Outcome measures include 6-month and 1-year weight loss, changes in medications, glycemic control, cardiac risk factors, and cost analysis. RESULTS: Patients were mean age 61, 59% male, and 32% non-white, and they weighed 97 kg with mean HbA1c 8.2%. At 6 months, 46% of GLI vs. 21% of RD lost ≥5% body weight (P = 0.04), with mean weight loss 6.6 (SD 7.0) kg with GLI and 2.1 (3.5) kg in RD (P = 0.004). HbA1c improved by 0.70 (1.13) vs. 0.39 (1.51) in GLI vs. RD (P = 0.4), respectively, and 82% vs. 38% stopped or reduced diabetes medications (P < 0.001). Weight loss remained significantly greater in GLI compared to RD at 1 year. GLI program cost was $578 per participant. CONCLUSIONS: An affordable GLI achieved significantly more weight loss and medication reduction than RD in primary care patients with type 2 diabetes.

Short and long-term lifestyle coaching approaches used to address diverse participant barriers to weight loss and physical activity adherence.

BACKGROUND: Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program, a randomized trial with 3.2 years average treatment duration, have not been previously reported. Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large, diverse participant cohort can inform dissemination efforts. METHODS: Lifestyle coaches documented barriers and approaches after each session (mean session attendance = 50.3 ± 21.8). Subjects were 1076 intensive lifestyle participants (mean age = 50.6 years; mean BMI = 33.9 kg/m²; 68% female, 48% non-Caucasian). Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied. Barrier groupings were also analyzed in relation to baseline demographic characteristics. RESULTS: Top weight loss barriers reported were problems with self-monitoring (58%); social cues (58%); holidays (54%); low activity (48%); and internal cues (thought/mood) (44%). Top activity barriers were holidays (51%); time management (50%); internal cues (30%); illness (29%), and motivation (26%). The percentage of the cohort having any type of barrier increased over the long-term intervention period. A majority of the weight loss barriers were significantly associated with younger age, greater obesity, and non-Caucasian race/ethnicity (p-values vary). Physical activity barriers, particularly thought and mood cues, social cues and time management, physical injury or illness and access/weather, were most significantly associated with being female and obese (p < 0.001 for all). Lifestyle coaches used problem-solving with most participants (≥75% short-term; > 90% long term) and regularly reviewed self-monitoring skills. More costly approaches were used infrequently during the first 16 sessions (≤10%) but increased over 3.2 years. CONCLUSION: Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers. Given minimal resources, increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted.

Genetic modifiers of cardiorespiratory fitness response to lifestyle intervention.

PURPOSE: Numerous prospective studies indicate that improved cardiorespiratory fitness reduces type 2 diabetes risk and delays disease progression. We hypothesized that genetic variants modify fitness response to an intensive lifestyle intervention (ILI) in the Action for Health in Diabetes (Look AHEAD) randomized clinical trial, aimed to detect whether ILI will reduce cardiovascular events in overweight/obese subjects with type 2 diabetes compared with a standard of care. METHODS: Polymorphisms in established fitness genes and in all loci assayed on the Illumina CARe iSelect chip were examined as predictors of change in MET level, estimated using a treadmill test, in response to a 1-yr intervention in 3899 participants. RESULTS: We identified a significant signal in previously reported fitness-related gene RUNX1 that was associated with 1-yr METs response in ILI (0.19 ± 0.04 MET less improvement per minor allele copy; P = 1.9 × 10(-5)) and genotype-intervention interaction (P = 4.8 × 10(-3)). In the chipwide analysis, FKBP7 rs17225700 showed a significant association with ILI response among subjects not receiving beta-blocker medications (0.47 ± 0.09 METs less improvement; P = 5.3 × 10(-5)) and genotype-treatment interaction (P = 5.3 × 10(-7)). The Gene Relationships Among Implicated Loci pathway-based analysis identified connections between associated genes, including those influencing vascular tone, muscle contraction, cardiac energy substrate dynamics, and muscle protein synthesis. CONCLUSIONS: This is the first study to identify genetic variants associated with fitness responses to a randomized lifestyle intervention in overweight/obese diabetic individuals. RUNX1 and FKBP7, involved in erythropoesis and muscle protein synthesis, respectively, are related to change in cardiorespiratory fitness in response to exercise.

Predictors of sustained reduction in energy and fat intake in the Diabetes Prevention Program Outcomes Study intensive lifestyle intervention.

BACKGROUND: Few lifestyle intervention studies examine long-term sustainability of dietary changes. OBJECTIVE: To describe sustainability of dietary changes over 9 years in the Diabetes Prevention Program and its outcomes study, the Diabetes Prevention Program Outcomes Study, among participants receiving the intensive lifestyle intervention. DESIGN: One thousand seventy-nine participants were enrolled in the intensive lifestyle intervention arm of the Diabetes Prevention Program; 910 continued participation in the Diabetes Prevention Program Outcomes Study. Fat and energy intake derived from food frequency questionnaires at baseline and post-randomization Years 1 and 9 were examined. Parsimonious models determined whether baseline characteristics and intensive lifestyle intervention session participation predicted sustainability. RESULTS: Self-reported energy intake was reduced from a median of 1,876 kcal/day (interquartile range [IQR]=1,452 to 2,549 kcal/day) at baseline to 1,520 kcal/day (IQR=1,192 to 1,986 kcal/day) at Year 1, and 1,560 kcal/day (IQR=1,223 to 2,026 kcal/day) at Year 9. Dietary fat was reduced from a median of 70.4 g (IQR=49.3 to 102.5 g) to 45 g (IQR=32.2 to 63.8 g) at Year 1 and increased to 61.0 g (IQR=44.6 to 82.7 g) at Year 9. Percent energy from fat was reduced from a median of 34.4% (IQR=29.6% to 38.5%) to 27.1% (IQR=23.1% to 31.5%) at Year 1 but increased to 35.3% (IQR=29.7% to 40.2%) at Year 9. Lower baseline energy intake and Year 1 dietary reduction predicted lower energy and fat gram intake at Year 9. Higher leisure physical activity predicted lower fat gram intake but not energy intake. CONCLUSIONS: Intensive lifestyle intervention can result in reductions in total energy intake for up to 9 years. Initial success in achieving reductions in fat and energy intake and success in attaining activity goals appear to predict long-term success at maintaining changes.

Association of an intensive lifestyle intervention with remission of type 2 diabetes.

CONTEXT: The frequency of remission of type 2 diabetes achievable with lifestyle intervention is unclear. OBJECTIVE: To examine the association of a long-term intensive weight-loss intervention with the frequency of remission from type 2 diabetes to prediabetes or normoglycemia. DESIGN, SETTING, AND PARTICIPANTS: Ancillary observational analysis of a 4-year randomized controlled trial (baseline visit, August 2001-April 2004; last follow-up, April 2008) comparing an intensive lifestyle intervention (ILI) with a diabetes support and education control condition (DSE) among 4503 US adults with body mass index of 25 or higher and type 2 diabetes. INTERVENTIONS: Participants were randomly assigned to receive the ILI, which included weekly group and individual counseling in the first 6 months followed by 3 sessions per month for the second 6 months and twice-monthly contact and regular refresher group series and campaigns in years 2 to 4 (n=2241) or the DSE, which was an offer of 3 group sessions per year on diet, physical activity, and social support (n=2262). MAIN OUTCOME MEASURES: Partial or complete remission of diabetes, defined as transition from meeting diabetes criteria to a prediabetes or nondiabetic level of glycemia (fasting plasma glucose <126 mg/dL and hemoglobin A1c <6.5% with no antihyperglycemic medication). RESULTS Intensive lifestyle intervention participants lost significantly more weight than DSE participants at year 1 (net difference, -7.9%; 95% CI, -8.3% to -7.6%) and at year 4 (-3.9%; 95% CI, -4.4% to -3.5%) and had greater fitness increases at year 1 (net difference, 15.4%; 95% CI, 13.7%-17.0%) and at year 4 (6.4%; 95% CI, 4.7%-8.1%) (P < .001 for each). The ILI group was significantly more likely to experience any remission (partial or complete), with prevalences of 11.5% (95% CI, 10.1%-12.8%) during the first year and 7.3% (95% CI, 6.2%-8.4%) at year 4, compared with 2.0% for the DSE group at both time points (95% CIs, 1.4%-2.6% at year 1 and 1.5%-2.7% at year 4) (P < .001 for each). Among ILI participants, 9.2% (95% CI, 7.9%-10.4%), 6.4% (95% CI, 5.3%-7.4%), and 3.5% (95% CI, 2.7%-4.3%) had continuous, sustained remission for at least 2, at least 3, and 4 years, respectively, compared with less than 2% of DSE participants (1.7% [95% CI, 1.2%-2.3%] for at least 2 years; 1.3% [95% CI, 0.8%-1.7%] for at least 3 years; and 0.5% [95% CI, 0.2%-0.8%] for 4 years). CONCLUSIONS: In these exploratory analyses of overweight adults, an intensive lifestyle intervention was associated with a greater likelihood of partial remission of type 2 diabetes compared with diabetes support and education. However, the absolute remission rates were modest. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00017953.

Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions.

The Diabetes Prevention Program (DPP) and Look AHEAD (Action for Health in Diabetes) trials are long-term randomized clinical trials that have the potential to direct diabetes care and medical nutrition therapy for obesity, prediabetes, and type 2 diabetes both now and in the future. This article summarizes and compares the important evidence-based results of these diabetes and obesity clinical trials and reviews the similarities and differences in lifestyle interventions that were designed for these trials. Although there were many similarities in the features of the DPP and Look AHEAD interventions, the Look AHEAD lifestyle intervention was more ambitious in several ways: higher individual weight-loss goals, lower calorie and fat-gram targets based on initial body weight, more intensive intervention frequency, combining closed group and individual session format, and use of more structured nutrition intervention strategies from the outset, including meal replacements, structured menus, and combined fat and calorie counting. Evidence, knowledge, and insights gained from working on these clinical trials will be very important in determining the strategies, methods, and approaches needed to make sure that the results of these trials will be fully applied in real-world practice settings for obesity, prediabetes, and type 2 diabetes.

Lifestyle intervention for the prevention of type 2 diabetes: translation and future recommendations.

The effectiveness of lifestyle intervention for the prevention of type 2 diabetes has recently been demonstrated. Four clinical trials using lifestyle interventions comprised of weight loss, physical activity, and diet have successfully prevented or delayed the onset of diabetes development in high-risk individuals. As we attempt to translate these results from the clinical trial to the community, it is important to understand the various components of the lifestyle intervention efforts used. After a description of the key lifestyle components of these clinical trials is provided, a discussion of possible suggestions for implementing these findings in the broader community setting is presented.

Psychological and behavioral correlates of baseline BMI in the diabetes prevention program (DPP).

OBJECTIVE: To determine psychological and behavioral correlates of baseline BMI in the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS: Of 1,079 DPP lifestyle intervention participants, 274 completed validated questionnaires at baseline assessing weight loss history, stage of change, self-efficacy, dietary restraint, emotional eating, binge eating, perceived stress, depression, and anxiety. RESULTS: The mean age of subjects was 52.5 years, 65% were women, and their mean BMI was 33.9 kg/m(2). Higher BMI correlated with more frequent weight cycling (r = 0.50, P < 0.0001) and efforts at weight loss (r = 0.34, P < 0.0001); younger age when first overweight (r = -0.42, P < 0.0001); lower exercise efficacy (r = -0.15, P = 0.015); lower weight loss efficacy (r = -0.21, P < 0.001); a less advanced stage of change for weight loss (r = -0.12, P = 0.04); more perceived stress (r = 0.14, P = 0.02); emotional eating (r = 0.19, P = 0.001); poor dietary restraint (r = -0.14, P = 0.02); binge eating frequency (r = 0.18, P = 0.004) and severity (r = 0.30, P < 0.0001); feeling deprived, angry, or upset while dieting (r = 0.27, P