Randomized controlled trial of a novel lifestyle intervention used with or without meal replacements in work sites.

OBJECTIVE: Lifestyle interventions have had limited effectiveness in work sites when evaluated in randomized trials. This study assessed the effectiveness of a novel lifestyle intervention for weight loss (Healthy Weight for Living [HWL]) implemented with or without meal replacements (MR) in work sites. HWL used a new behavioral approach emphasizing reducing hunger and building healthy food preferences, and, unlike traditional lifestyle interventions, it did not require calorie counting. METHODS: Twelve work sites were randomized to an 18-month intervention (n = 8; randomization within work sites to HWL, HWL + MR) or 6-month wait-listed control (n = 4). Participants were employees with overweight or obesity (N = 335; age = 48 [SD 10] years; BMI = 33 [6] kg/m2 ; 83% female). HWL was group-delivered in person or by videoconference. The primary outcome was 6-month weight change; secondary outcomes included weight and cardiometabolic risk factors measured at 6, 12, and 18 months in intervention groups. RESULTS: Mean 6-month weight change was -8.8% (95% CI: -11.2% to -6.4%) for enrollees in HWL and -8.0% (-10.4% to -5.5%) for HWL + MR (p < 0.001 for both groups vs. controls), with no difference between interventions (p = 0.40). Clinically meaningful weight loss (≥5%) was maintained at 18 months in both groups (p < 0.001). CONCLUSIONS: A new lifestyle intervention approach, deliverable by videoconference with or without MR, supported clinically impactful weight loss in employees.

Unrestrained eating behavior and risk of mortality: A prospective cohort study.

BACKGROUND & AIMS: Unrestrained eating behavior has been thought to be a proxy for diet frequency, timing, and caloric intake. We investigated the association of unrestrained eating with mortality risk in the Nurses' Health Study prospectively. METHODS: During follow-up (1994-2016), 21,953 deaths were documented among 63,999 eligible participants in analyses of eating anything at any time, 22,120 deaths were documented among 65,839 participants in analyses of no concern with figure change. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox proportional hazards models. RESULTS: Eating anything at any time was associated with an increased mortality from cancer (overall HR, 95%CI: 1.07, 1.00-1.13; driven by gastrointestinal tract cancer: 1.30, 1.10-1.54) and respiratory disease (1.16, 1.05-1.29), and decreased cardiovascular disease-specific mortality (0.92, 0.86-0.99), compared to those without this behavior; however, no association was observed between this behavior and all-cause mortality (1.02, 0.99-1.05). Women who reported having no concern with figure change experienced higher risk of mortality from all-cause (1.08, 1.05-1.11), cancer (1.08, 1.02-1.14), and respiratory disease (1.18, 1.08-1.30), compared to those not reporting this behavior. Their combined effect was associated with a higher all-cause (1.09, 1.04-1.14), cancer-specific (overall: 1.18, 1.09-1.28; gastrointestinal tract cancer: 1.36, 1.08-1.71; lung cancer: 1.09; 1.04-1.14), and respiratory disease-specific (1.30, 1.13-1.50) mortality, and was inversely associated with cardiovascular disease-specific mortality (0.88, 0.80-0.98), compared to those exhibiting the opposite. CONCLUSIONS: Unrestrained eating was associated with increased risk of all-cause, cancer-specific (particularly for gastrointestinal tract cancer and lung cancer), and respiratory disease-specific mortality, and decreased risk of cardiovascular disease-specific mortality.

Randomized trial of a novel lifestyle intervention compared with the Diabetes Prevention Program for weight loss in adult dependents of military service members.

BACKGROUND: Lifestyle interventions are the first-line treatment for obesity, but participant weight loss is typically low. OBJECTIVES: We evaluated the efficacy of an alternative lifestyle intervention [Healthy Weight for Living (HWL)] compared with a modified Diabetes Prevention Program (m-DPP). HWL was based on a revised health behavior change model emphasizing hunger management and the development of healthy food preferences. m-DPP was a standard Diabetes Prevention Program implemented with counselor time matched to HWL. Participants were adult dependents of military personnel and had overweight or obesity. METHODS: Participants were randomly assigned to HWL (n = 121) or m-DPP (n = 117), delivered primarily by group videoconference with additional midweek emails. The primary outcome was 12-mo weight change. Secondary outcomes included 6-mo changes in cardiometabolic risk factors and diet. Intention-to-treat (ITT) and complete case (CC) analyses were performed using linear mixed models. RESULTS: Retention did not differ between groups (72% and 66% for HWL and m-DPP at 12 mo, respectively; P = 0.30). Mean ± SE adjusted 12-mo weight loss in the ITT cohort was 7.46 ± 0.85 kg for HWL and 7.32 ± 0.87 kg for m-DPP (P = 0.91); in the CC cohort, it was 7.83 ± 0.82 kg for HWL and 6.86 ± 0.88 kg for m-DPP (P = 0.43). Thirty-eight percent of HWL and 30% of m-DPP completers achieved ≥10% weight loss (P = 0.32). Improvements in systolic blood pressure, LDL cholesterol, triglycerides, fasting glucose, general health, sleep, and mood were similar across groups; improvements in diastolic blood pressure were greater in m-DPP. Adjusted group mean reductions in energy intake were not significantly different between groups, but HWL participants were more adherent to their dietary prescription for lower glycemic index and high fiber and protein (P = 0.05 to <0.001 for ITT). CONCLUSIONS: HWL and m-DPP showed equivalent and clinically impactful mean weight loss with cardiometabolic benefits. These results identify an alternative approach for behavioral treatment of overweight and obesity.This trial was registered at clinicaltrials.gov as NCT02348853.

Unrestrained eating behavior and risk of digestive system cancers: a prospective cohort study.

BACKGROUND: Unrestrained eating behavior, as a potential proxy for diet frequency, timing, and caloric intake, has been questioned as a plausible risk factor for digestive system cancers, but epidemiological evidence remains sparse. OBJECTIVES: We investigated prospectively the associations between unrestrained eating behavior and digestive system cancer risk. METHODS: Participants in the Nurses' Health Study who were free of cancer and reported dietary information in 1994 were followed for ≤18 y. Cox models were used to estimate HRs and 95% CIs for unrestrained eating (eating anything at any time, no concern with figure change, or both) and risk of digestive system cancers. RESULTS: During follow-up, 2064 digestive system cancer cases were documented among 70,450 eligible participants in analyses of eating anything at any time, In total, 2081 digestive system cancer cases were documented among 72,468 eligible participants in analyses of no concern with figure change. In fully adjusted analyses, women with the behavior of eating anything at any time had a higher risk of overall digestive system cancer (HR: 1.22; 95% CI: 1.10, 1.35), overall gastrointestinal tract cancer ((HR: 1.33; 95% CI: 1.18, 1.50), buccal cavity and pharynx cancer (HR: 1.50; 95% CI: 1.02, 2.21), esophageal cancer (HR: 1.62; 95% CI: 1.01, 2.62), small intestine cancer (HR: 1.92; 95% CI: 1.02,3. 59), and colorectal cancer (HR: 1.20; 95% CI: 1.04, 1.38), and a non-statistically significant increased risk of stomach cancer (HR: 1.54; 95% CI: 0.96,2.48), compared with women without this behavior. No statistically significant association was observed for pancreatic cancer and liver and gallbladder cancer. The combined effect of eating anything at any time and having no concern with figure change was associated with a significantly increased risk of overall digestive system cancer (HR: 1.27; 95% CI: 1.10, 1.46), overall gastrointestinal tract cancer (HR: 1.45; 95% CI: 1.23, 1.71), and colorectal cancer (HR: 1.34; 95% CI: 1.11, 1.63), compared with women exhibiting the opposite. CONCLUSIONS: Unrestrained eating behavior was independently associated with increased risk of gastrointestinal tract cancers. The potential importance of unrestrained eating behavior modification in preventing gastrointestinal tract cancers should be noted.

Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial.

OBJECTIVE: To assess the effects of food supplementation on improving working memory and additional measures including cerebral blood flow in children at risk of undernutrition. DESIGN: Randomized controlled trial. SETTING: 10 villages in Guinea-Bissau. PARTICIPANTS: 1059 children aged 15 months to 7 years; children younger than 4 were the primary population. INTERVENTIONS: Supervised isocaloric servings (≈1300 kJ, five mornings each week, 23 weeks) of a new food supplement (NEWSUP, high in plant polyphenols and omega 3 fatty acids, within a wide variety and high fortification of micronutrients, and a high protein content), or a fortified blended food (FBF) used in nutrition programs, or a control meal (traditional rice breakfast). MAIN OUTCOME MEASUREMENTS: The primary outcome was working memory, a core executive function predicting long term academic achievement. Additional outcomes were hemoglobin concentration, growth, body composition, and index of cerebral blood flow (CBFi). In addition to an intention-to-treat analysis, a predefined per protocol analysis was conducted in children who consumed at least 75% of the supplement (820/925, 89%). The primary outcome was assessed by a multivariable Poisson model; other outcomes were assessed by multivariable linear mixed models. RESULTS: Among children younger than 4, randomization to NEWSUP increased working memory compared with the control meal (rate ratio 1.20, 95% confidence interval 1.02 to 1.41, P=0.03), with a larger effect in the per protocol population (1.25, 1.06 to 1.47, P=0.009). NEWSUP also increased hemoglobin concentration among children with anemia (adjusted mean difference 0.65 g/dL, 95% confidence interval 0.23 to 1.07, P=0.003) compared with the control meal, decreased body mass index z score gain (-0.23, -0.43 to -0.02, P=0.03), and increased lean tissue accretion (2.98 cm2, 0.04 to 5.92, P=0.046) with less fat (-5.82 cm2, -11.28 to -0.36, P=0.04) compared with FBF. Additionally, NEWSUP increased CBFi compared with the control meal and FBF in both age groups combined (1.14 mm2/s×10-8, 0.10 to 2.23, P=0.04 for both comparisons). Among children aged 4 and older, NEWSUP had no significant effect on working memory or anemia, but increased lean tissue compared with FBF (4.31 cm2, 0.34 to 8.28, P=0.03). CONCLUSIONS: Childhood undernutrition is associated with long term impairment in cognition. Contrary to current understanding, supplementary feeding for 23 weeks could improve executive function, brain health, and nutritional status in vulnerable young children living in low income countries. Further research is needed to optimize nutritional prescriptions for regenerative improvements in cognitive function, and to test effectiveness in other vulnerable groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03017209.

Different and Unequal: A Qualitative Evaluation of Salient Factors Influencing Energy Intake in Adults with Overweight and Obesity.

Environmental factors such as food availability and variety can function as cues for overeating in individuals susceptible to overweight or obesity, but relatively little is known about other types of environmental factors that may also be important. This qualitative study compared and contrasted categories of internal and external cues through focus groups and key informant interviews with 24 adults (26 to 77 years old) in the United States who had a body mass index within the healthy range (21.6 ± 2.5 kg/m2) or had overweight or obesity (29.1 ± 3.6 kg/m2). Five domains of external factors influencing food intake were identified: (a) Environmental cues including food availability and variety; (b) normative expectations for dietary intake; (c) food palatability; (d) overt social pressures to overeat; and (e) perceived social expectations around eating. All external domains were noted by participants with overweight or obesity to be challenging, and solutions to avoid overeating were lacking; however, overt social pressures and perceived social expectations appeared to be especially problematic. By explicitly defining different domains of external factors that challenge healthy weight regulation, this study identifies specific targets to address in interventions for healthy weight management.

Long-term moderate calorie restriction inhibits inflammation without impairing cell-mediated immunity: a randomized controlled trial in non-obese humans.

Calorie restriction (CR) inhibits inflammation and slows aging in many animal species, but in rodents housed in pathogen-free facilities, CR impairs immunity against certain pathogens. However, little is known about the effects of long-term moderate CR on immune function in humans. In this multi-center, randomized clinical trial to determine CR's effect on inflammation and cell-mediated immunity, 218 healthy non-obese adults (20-50 y), were assigned 25% CR (n=143) or an ad-libitum (AL) diet (n=75), and outcomes tested at baseline, 12, and 24 months of CR. CR induced a 10.4% weight loss over the 2-y period. Relative to AL group, CR reduced circulating inflammatory markers, including total WBC and lymphocyte counts, ICAM-1 and leptin. Serum CRP and TNF-α concentrations were about 40% and 50% lower in CR group, respectively. CR had no effect on the delayed-type hypersensitivity skin response or antibody response to vaccines, nor did it cause difference in clinically significant infections. In conclusion, long-term moderate CR without malnutrition induces a significant and persistent inhibition of inflammation without impairing key in vivo indicators of cell-mediated immunity. Given the established role of these pro-inflammatory molecules in the pathogenesis of multiple chronic diseases, these CR-induced adaptations suggest a shift toward a healthy phenotype.

Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and U.S. Department of Agriculture Database Information: A Multisite Randomized Study.

BACKGROUND: Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ∼50% of US restaurants are individual or small-chain (non-chain) establishments that do not provide nutrition information. OBJECTIVE: To measure the energy content of frequently ordered meals in non-chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. DESIGN: A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non-chain restaurants, together with equivalent meals from large-chain restaurants. SETTING: Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. MAIN OUTCOME MEASURES: Meal energy content determined by bomb calorimetry. STATISTICAL ANALYSIS PERFORMED: Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non-chain and chain meals, human energy requirements, and food database values. RESULTS: Meals from non-chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non-chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. CONCLUSIONS: Non-chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized for providing excess energy. Restaurants in general, rather than specific categories of restaurant, expose patrons to excessive portions that induce overeating through established biological mechanisms.

A 2-Year Randomized Controlled Trial of Human Caloric Restriction: Feasibility and Effects on Predictors of Health Span and Longevity.

BACKGROUND: Caloric restriction (CR), energy intake reduced below ad libitum (AL) intake, increases life span in many species. The implications for humans can be clarified by randomized controlled trials of CR. METHODS: To determine CR's feasibility, safety, and effects on predictors of longevity, disease risk factors, and quality of life in nonobese humans aged 21-51 years, 218 persons were randomized to a 2-year intervention designed to achieve 25% CR or to AL diet. Outcomes were change from baseline resting metabolic rate adjusted for weight change ("RMR residual") and core temperature (primary); plasma triiodothyronine (T3) and tumor necrosis factor-α (secondary); and exploratory physiological and psychological measures. RESULTS: Body mass index averaged 25.1 (range: 21.9-28.0 kg/m(2)). Eighty-two percent of CR and 95% of AL participants completed the protocol. The CR group achieved 11.7±0.7 %CR (mean ± standard error) and maintained 10.4±0.4% weight loss. Weight change in AL was negligible. RMR residual decreased significantly more in CR than AL at 12 months (p = .04) but not 24 months (M24). Core temperature change differed little between groups. T3 decreased more in CR at M12 and M24 (p < .001), while tumor necrosis factor-α decreased significantly more only at M24 (p = .02). CR had larger decreases in cardiometabolic risk factors and in daily energy expenditure adjusted for weight change, without adverse effects on quality of life. CONCLUSIONS: Sustained CR is feasible in nonobese humans. The effects of the achieved CR on correlates of human survival and disease risk factors suggest potential benefits for aging-related outcomes that could be elucidated by further human studies.

Assessing Dietary Intake in Childhood Cancer Survivors: Food Frequency Questionnaire Versus 24-Hour Diet Recalls.

Cancer diagnosis and treatment may influence dietary intake. The validity of using self-reported methods to quantify dietary intake has not been evaluated in childhood cancer survivors. We validated total energy intake (EI) reported from Food Frequency Questionnaire (FFQ) and repeated 24-hour diet recalls (24HRs) against total energy expenditure (TEE) measured using the doubly labeled water method in 16 childhood cancer survivors. Dietary underreporting, assessed by (EI-TEE)/TEE × 100%, was 22% for FFQ and 1% for repeated 24HRs. FFQ significantly underestimates dietary intake and should not be used to assess the absolute intake of foods and nutrients in childhood cancer survivors.

Comparison of childhood cancer survivors' nutritional intake with US dietary guidelines.

BACKGROUND: Despite improved survival, childhood cancer survivors experience significantly elevated risk of premature mortality and serious morbidity due to chronic health conditions. Poor diet quality can exacerbate chronic health conditions in the survivors but their nutritional intake has not been adequately studied. PROCEDURE: We assessed the Healthy Eating Index 2010 (HEI-2010) in 22 survivors of pediatric acute lymphoblastic leukemia and lymphoma (median age = 11.7 years) and compared survivors' dietary intake to the 2010 Dietary Guidelines for Americans. Dietary data were collected using repeated 24 hr dietary recalls over a 1-year period, which were averaged to estimate habitual intake. RESULTS: The mean HEI-2010 in childhood cancer survivors was 52.7, about 50 percent of the maximum score. Long-term survivors (time from diagnosis ≥10 years) had a significantly lower HEI-2010 than recent survivors (time from diagnosis <5 years) (ß = -11.5, 95% CI: -22.1, -0.9, P = 0.047). For individual food groups and nutrients, survivors had a particularly poor adherence to green vegetables and beans, total vegetables, and whole fruits. None of the survivors met the guidelines for dietary fiber and potassium intake. Only 4%, 19%, 24%, and 29% met the guidelines for vitamin D, sodium, calcium, and saturated fat intake. The average intake in relative to the recommended intake was 32% for vitamin D, 50% for potassium, 63% for fiber, and 85% for calcium, but was 115% for saturated fat and 143% for sodium. CONCLUSIONS: Childhood cancer survivors, in particular long-term survivors, have a poor adherence to the US dietary guidelines.

Low Levels of Energy Expenditure in Childhood Cancer Survivors: Implications for Obesity Prevention.

Childhood cancer survivors are at an increased risk of obesity but causes for this elevated risk are uncertain. We evaluated total energy expenditure in childhood cancer survivors using the doubly labeled water method in a cross-sectional study of 17 survivors of pediatric leukemia or lymphoma (median age, 11.5 y). Mean total energy expenditure was 2073 kcal/d, which was nearly 500 kcal/d lower than estimated energy requirements with recommended levels of physical activity. This energy gap is likely to contribute to the risk of obesity in this population and future trials are needed to assess implications and potential treatment strategies.

Preclinical characterization of BMS-791325, an allosteric inhibitor of hepatitis C Virus NS5B polymerase.

BMS-791325 is an allosteric inhibitor that binds to thumb site 1 of the hepatitis C virus (HCV) NS5B RNA-dependent RNA polymerase. BMS-791325 inhibits recombinant NS5B proteins from HCV genotypes 1, 3, 4, and 5 at 50% inhibitory concentrations (IC50) below 28 nM. In cell culture, BMS-791325 inhibited replication of HCV subgenomic replicons representing genotypes 1a and 1b at 50% effective concentrations (EC50s) of 3 nM and 6 nM, respectively, with similar (3 to 18 nM) values for genotypes 3a, 4a, and 5a. Potency against genotype 6a showed more variability (9 to 125 nM), and activity was weaker against genotype 2 (EC50, 87 to 925 nM). Specificity was demonstrated by the absence of activity (EC50s of >4 µM) against a panel of mammalian viruses, and cytotoxic concentrations (50%) were >3,000-fold above the HCV EC50. Resistance substitutions selected by BMS-791325 in genotype 1 replicons mostly mapped to a single site, NS5B amino acid 495 (P495A/S/L/T). Additive or synergistic activity was observed in combination studies using BMS-791325 with alfa interferon plus ribavirin, inhibitors of NS3 protease or NS5A, and other classes of NS5B inhibitor (palm site 2-binding or nucleoside analogs). Plasma and liver exposures in vivo in several animal species indicated that BMS-791325 has a hepatotropic disposition (liver-to-plasma ratios ranging from 1.6- to 60-fold across species). Twenty-four hours postdose, liver exposures across all species tested were ≥ 10-fold above the inhibitor EC50s observed with HCV genotype 1 replicons. These findings support the evaluation of BMS-791325 in combination regimens for the treatment of HCV. Phase 3 studies are ongoing.

Predictors of being overweight or obese in survivors of pediatric acute lymphoblastic leukemia (ALL).

BACKGROUND: A high prevalence of obesity has been increasingly recognized in survivors of pediatric ALL. However, longitudinal patterns of weight change during and after treatment, and associated factors, are less well elucidated. PROCEDURE: In a retrospective cohort of 83 pediatric patients with ALL diagnosed between 1985 and 2010, we examined body mass index (BMI) status at several key time points: diagnosis; end of induction; end of consolidation; every 6 months during maintenance; and yearly for up to 5 years post-treatment. RESULTS: At diagnosis, 21% were overweight (BMI = 85-94.9th percentile) or obese (BMI ≥ 95th percentile). At the end of treatment and 5 years post-treatment, approximately 40% were overweight or obese. The mean BMI z-score was 0.2 (58th percentile) at diagnosis and increased significantly during induction (Δ = 0.5, P < 0.0001). It increased again during the first 6 months of maintenance (Δ = 0.2, P < 0.01) and did not significantly change over the remainder of maintenance (BMI z-score at the end of treatment = 0.8, 79th percentile) and 5 years post-treatment (BMI z-score = 0.7, 76th percentile). High BMI z-score at diagnosis was associated with an increased risk of being overweight/obese at treatment completion (OR = 2.9, 95% CI: 1.6-5.1). Weight gain during treatment was associated with being overweight/obese 5 years post-treatment (OR = 3.8, 95% CI: 1.1-12.5). CONCLUSION: Children with ALL are at risk of becoming overweight/obese early in treatment. Increases in weight are maintained throughout treatment and beyond. Lifestyle interventions are needed targeting weight control early during treatment, particularly for patients overweight/obese at diagnosis and those who experience substantial weight gain during treatment.

Obesity in pediatric ALL survivors: a meta-analysis.

BACKGROUND AND OBJECTIVE: Previous studies of survivors of pediatric acute lymphoblastic leukemia (ALL) have drawn heterogeneous conclusions regarding the prevalence of obesity and risk factors for developing obesity in pediatric ALL survivors. We sought to determine the prevalence of obesity in pediatric ALL survivors and examine risk factors for obesity through a systematic review and meta-analysis. METHODS: A MEDLINE search was performed from its inception through 2013. Studies met the inclusion criteria if they (1) included at least 10 survivors of pediatric ALL; (2) assessed the prevalence or indicators of obesity; and (3) compared obesity among ALL survivors to a reference population or external control group. Extracted data included patient and treatment characteristics, study design, population used for comparison, and prevalence of obesity. RESULTS: Forty-seven studies met the inclusion criteria. Despite significant heterogeneity among the studies (I(2) = 96%), the mean BMI z score in 1742 pediatric ALL survivors was 0.83 (95% confidence interval: 0.60-1.06), which corresponds to the 80th BMI percentile, indicating a significantly higher BMI in pediatric ALL survivors than the reference population. Subgroup analyses found a high prevalence of obesity in ALL survivors regardless of survivors' receipt of cranial irradiation, gender, or age at diagnosis. CONCLUSIONS: Obesity is prevalent in pediatric ALL survivors and is independent of patient- and treatment-related characteristics. Clinicians need to screen for obesity and its associated health conditions early in survivorship.

Update on human calorie restriction research.

The United States population is aging rapidly, and understanding the potential impact and feasibility of lifestyle interventions on the aging process is of central importance for addressing future population health and health care costs. This symposium addressed the question of whether caloric restriction may be a feasible strategy to improve human health by reductions in rates of primary and secondary aging in humans, viewed from the perspective of existing data in animal models, and by using emerging data from the human Comprehensive Assessment of Long-Term Reduction in Energy Intake trial, which is a randomized trial of human caloric restriction in free-living men and women.

Lifestyle intervention reduces body weight and improves cardiometabolic risk factors in worksites.

BACKGROUND: Worksites are potentially effective locations for obesity control because they provide opportunities for group intervention and social support. Studies are needed to identify effective interventions in these settings. OBJECTIVE: We examined the effects of a multicomponent lifestyle intervention on weight loss and prevention of regain in 4 worksites (2 intervention and 2 control sites). DESIGN: Overweight and obese employees (n = 133) enrolled in this pilot worksite-randomized controlled trial with a 0-6-mo weight-loss phase and a 6-12-mo structured weight-maintenance phase. The intervention combined recommendations to consume a reduced-energy, low-glycemic load, high-fiber diet with behavioral change education. Outcome measurements included changes in body weight and cardiometabolic risk factors. RESULTS: The mean ± SEM weight loss was substantial in intervention participants, whereas control subjects gained weight (-8.0 ± 0.7 compared with +0.9 ± 0.5 kg, respectively; P < 0.001), and 89% of participants completed the weight-loss phase. Intervention effects were not significant at the 0.05 level but would have been at the 0.10 level (P = 0.08) in a mixed model in which the worksite nested within group was a random factor. There were also significant improvements in cardiometabolic risk factors in intervention compared with control subjects regarding fasting total cholesterol, glucose, systolic blood pressure, and diastolic blood pressure (P ≤ 0.02 for each). No significant weight regain was observed in participants who enrolled in the structured weight-maintenance program (0.5 ± 0.7 kg; P = 0.65), and overweight and obese employees in intervention worksites who were not enrolled in the weight-loss program lost weight compared with subjects in control worksites (-1.3 ± 0.5 compared with +0.7 ± 0.2 kg, respectively; P = 0.02). CONCLUSION: Worksites can be effective for achieving clinically important reductions in body weight and improved cardiometabolic risk factors. This trial was registered at clinicaltrials.gov as NCT01470222.

Aspects of eating behaviors "disinhibition" and "restraint" are related to weight gain and BMI in women.

OBJECTIVE: The causes of adult weight gain leading to obesity are uncertain. We examined the association of adult weight gain and obesity with subscales of eating behavior characteristics in older women. METHODS AND PROCEDURES: Current height and weight, eating behavior subscales (disinhibition subscales-habitual, situational, and emotional; restraint subscales-flexible and rigid; hunger subscales-internal and external) as assessed using the Eating Inventory (EI), and self-reported body weight at six prior age intervals were reported by 535 women aged 55-65 years. Multiple regression analysis was used to examine the relationships between EI subscale scores and weight change from the age interval of 30-39 to 55-60 years and current BMI. RESULTS: The strongest correlate of weight gain over 20 years was susceptibility to overeating in response to everyday cues within the environment (habitual disinhibition; partial correlation coefficient (r) = 0.25, P < 0.001); susceptibility to overeating in response to emotional states such as depression (emotional disinhibition) was a quantitatively weaker but significant correlate (partial r = 0.17, P < 0.001), and susceptibility to overeating in response to specific situations such as social occasions (situational disinhibition) was not associated with weight gain. Flexible control of dietary restraint attenuated the influence of habitual disinhibition in particular on weight gain and BMI, and was less effective in attenuating associations of emotional or situational disinhibition. DISCUSSION: Lifestyle modification programs for prevention and treatment of adult-onset obesity currently focus on reducing situational and emotional overeating; the results of this study suggest that a stronger emphasis on strategies that target habitual overeating may be warranted.

Trajectories and predictors of anxiety and depression in women during the 12 months following an acute cardiac event.

OBJECTIVES: Many previous investigations of the recovery of emotional well-being, particularly the resolution of depression, following an acute cardiac event assume that all patients follow a similar, linear trajectory. However, it is possible that there are different groups of patients who follow different trajectories. This study tested for multiple trajectories of anxiety and depression and identified the characteristics of patients most at risk for persistent or worsening anxiety and depression in the 12 months following their cardiac event. METHOD: A consecutive sample of 226 women was interviewed following either acute myocardial infarction (AMI) or coronary artery bypass graft surgery (CABGS). The Hospital Anxiety and Depression Scale were administered on four occasions over 12 months. Growth curve and growth mixture modelling were used to identify trajectories of change and univariate tests were employed to establish predictors of each trajectory. RESULTS: Most women began with relatively low levels of anxiety and/or depression that improved over the 12 month period (84% women showed this trajectory for anxiety, 89% for depression). A smaller group began with relatively high levels of anxiety and/or depression that worsened over time (16% for anxiety, 11% for depression). Patients in the latter group were more likely to report high levels of loneliness, have a first language other than English, perceive their cardiac disease as more severe (anxiety group only) and have diabetes (depression group only). Trajectories were non-linear, with most change occurring in the initial 2-month period. CONCLUSION: Growth modelling techniques highlight that change in anxiety and depression following an acute event follows neither a single nor linear trajectory. Most women showed early resolution of anxiety and depression following their event, indicative of a normal bereavement or adjustment response. A minority of women reported worsening anxiety and/or depression in the year following their cardiac event, particularly those who lacked social support or were from non-English speaking backgrounds. Intervention studies to explore support options for these women are warranted, both prior to and following their event.