The Look AHEAD study: a description of the lifestyle intervention and the evidence supporting it

The Look AHEAD (Action for Health in Diabetes) study is a multicenter, randomized controlled trial designed to determine whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes. The study began in 2001 and is scheduled to conclude in 2012. A total of 5145 participants have been randomly assigned to a lifestyle intervention or to an enhanced usual care condition (i.e., diabetes support and education). This article describes the lifestyle intervention and the empirical evidence to support it. The two principal intervention goals are to induce a mean loss >or = 7% of initial weight and to increase participants' moderately intense physical activity to > or =175 min/wk. For the first 6 months, participants attend one individual and three group sessions per month and are encouraged to replace two meals and one snack a day with liquid shakes and meal bars. From months 7 to 12, they attend one individual and two group meetings per month and continue to replace one meal per day (which is recommended for the study's duration). Starting at month 7, more intensive behavioral interventions and weight loss medication are available from a toolbox, designed to help participants with limited weight loss. In Years 2 to 4, treatment is provided mainly on an individual basis and includes at least one on-site visit per month and a second contact by telephone, mail, or e-mail. After Year 4, participants are offered monthly individual visits. The intervention is delivered by a multidisciplinary team that includes medical staff who monitor participants at risk of hypoglycemic episodes.     

Changes over four years in body composition and oxygen uptake of young adult males after university graduation

Lifestyle changes and challenges following university graduation often present a sharp contrast to the relatively free and basically pleasant university life enjoyed by the typical college student. Adaptation to a new work environment, relocation to a new community, concerns of marriage and family, personal finances, including income and budgeting (automobile and mortgage payments, savings, etc.), and adjustment to independent living result in an unfamiliar schedule of duties, often too sedentary in nature.The aim of this study was to analyse the changes observed in young working professionals by comparing selected body composition estimates, and physiological working capacity variables at the time of university graduation and four years later.Anthropometric and functional cardio-respiratory exercise test data were collected in 26 physically active (but non-athletic) volunteer males at the time of their university graduation in 2000 and 4 years later in 2004. By the end of this four-year period body weight, body mass index (BMI), the sum of 5 skinfold thicknesses, and relative body fat content increased significantly. Both mean BMI and weight-related body fat content were within the categorized risk range at the time of the second data collection. Parallel with unfavourable changes in body composition, peak minute ventilation, aerobic power, oxygen pulse, and maximum treadmill running distance had decreased significantly during this time. We attributed the significant changes observed mainly to the dramatically changed lifestyle. The subjects could not maintain their previous level of habitual physical activity.     

Preoperative lifestyle intervention in bariatric surgery: Initial results from a randomized,controlled trial

Objective:

To document preoperative outcomes of a behavioral lifestyle intervention delivered to patients prior to bariatric surgery in comparison to treatment as usual (insurance‐mandated physician supervised diet).

Design and Methods:

After completing a baseline assessment, candidates for surgery were randomized to a 6‐month, evidence‐informed, manualized lifestyle intervention (LIFESTYLE, n = 121) or to preoperative care as usual (USUAL CARE, n = 119). At 6 months, 187 participants remained candidates for bariatric surgery and were included in the analyses.

Results:

LIFESTYLE participants lost significantly more weight than those receiving USUAL CARE [8.3 ± 7.8 kg vs. 3.3 ± 5.5 kg, F(1,183) = 23.6, P < 0.0001], with an effect size of 0.72. Additionally, logistic regression modeling indicated that LIFESTYLE patients were significantly more likely to lose at least 5% of initial body weight than those in USUAL CARE [OR (95% CI) = 2.94 (1.253, 6.903)], as were participants who were heavier [OR (95% CI) = 1.07 (1.001‐1.14) for each unit increase in BMI] or with larger improvements in eating behaviors [OR (95% CI) = 1.1 (1.049, 1.145) for each unit increase on the Eating Behavior Inventory).

Conclusions:

A behavioral lifestyle intervention for severely overweight individuals leads to clinically significant weight loss prior to bariatric surgery. Post‐surgery follow‐up will allow us to examine the impact of the preoperative intervention on postoperative outcomes.     

Changes in body composition with weight loss: obese subjects randomized to surgical and medical programs

Objective: To assess changes in body composition with weight loss in obese subjects randomized to a laparoscopic adjustable gastric band surgical program or a medical program using a very‐low‐energy diet and orlistat. Research Methods and Procedures: Using body composition measurements by DXA, neutron activation for total body nitrogen, and whole body γ counting for total body potassium, we studied changes in fat mass, fat distribution, fat‐free mass, total bone mineral content, total body protein, and body cell mass at 6 (n = 61 paired) and 24 months (n = 53 paired) after randomization. Results: At 24 months, the surgical group had lost significantly more weight (surgical, 20.3 ± 6.5 kg; medical, 5.9 ± 8.0 kg). There was favorable fat‐free mass to fat mass loss ratios for both groups (surgical, 1:5.5; medical, 1:5.9). Changes in total body nitrogen or potassium were favorable in each group. A small reduction in mean bone mineral content occurred throughout the study but was not associated with extent of weight loss or treatment group. At 6 months, weight loss for both groups was similar (surgical, 14.1 ± 4.5 kg; medical, 13.3 ± 7.3 kg). The medical program subjects lost less fat‐free mass and skeletal muscle and had increased total body protein. The proportion of body fat to limb fat remained remarkably constant throughout the study. Discussion: Weight loss programs used in this study induced fat loss without significant deleterious effects on the components of fat‐free mass.     

Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial

BackgroundWomen with obesity and infertility are counseled to lose weight prior to conception and infertility treatment to improve pregnancy rates and birth outcomes, although confirmatory evidence from randomized trials is lacking. We assessed whether a preconception intensive lifestyle intervention with acute weight loss is superior to a weight neutral intervention at achieving a healthy live birth.Methods and findingsIn this open-label, randomized controlled study (FIT-PLESE), 379 women with obesity (BMI ≥ 30 kg/m²) and unexplained infertility were randomly assigned in a 1:1 ratio to 2 preconception lifestyle modification groups lasting 16 weeks, between July 2015 and July 2018 (final follow-up September 2019) followed by infertility therapy. The primary outcome was the healthy live birth (term infant of normal weight without major anomalies) incidence. This was conducted at 9 academic health centers across the United States. The intensive group underwent increased physical activity and weight loss (target 7%) through meal replacements and medication (Orlistat) compared to a standard group with increased physical activity alone without weight loss. This was followed by standardized empiric infertility treatment consisting of 3 cycles of ovarian stimulation/intrauterine insemination. Outcomes of any resulting pregnancy were tracked. Among 191 women randomized to standard lifestyle group, 40 dropped out of the study before conception; among 188 women randomized to intensive lifestyle group, 31 dropped out of the study before conception. All the randomized women were included in the intent-to-treat analysis for primary outcome of a healthy live birth. There were no significant differences in the incidence of healthy live births [standard 29/191(15.2%), intensive 23/188(12.2%), rate ratio 0.81 (0.48 to 1.34), P = 0.40]. Intensive had significant weight loss compared to standard (−6.6 ± 5.4% versus −0.3 ± 3.2%, P < 0.001). There were improvements in metabolic health, including a marked decrease in incidence of the metabolic syndrome (baseline to 16 weeks: standard: 53.6% to 49.4%, intensive 52.8% to 32.2%, P = 0.003). Gastrointestinal side effects were significantly more common in intensive. There was a higher, but nonsignificant, first trimester pregnancy loss in the intensive group (33.3% versus 23.7% in standard, 95% rate ratio 1.40, 95% confidence interval [CI]: 0.79 to 2.50). The main limitations of the study are the limited power of the study to detect rare complications and the design difficulty in finding an adequate time matched control intervention, as the standard exercise intervention may have potentially been helpful or harmful.ConclusionsA preconception intensive lifestyle intervention for weight loss did not improve fertility or birth outcomes compared to an exercise intervention without targeted weight loss. Improvement in metabolic health may not translate into improved female fecundity.Trial registrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02432209","term_id":"NCT02432209"}}NCT02432209.

Richard Legro and colleagues investigate the impact of a preconception weight loss intervention on healthy live birth rates in women with obesity and unexplained infertility.     

The efficacy of a comprehensive lifestyle modification programme based on yoga in the management of bronchial asthma: a randomized controlled trial

Background

Interferon gamma release assays, including the QuantiFERON^® TB Gold In Tube (QFT) have been shown to be accurate in diagnosing Mycobacterium tuberculosis infection. These assays however, do not discriminate between latent TB infection (LTBI) and active TB disease.

Methods

We recruited twenty-three pulmonary TB patients and 34 household contacts from Cape Town, South Africa and performed the QFT test. To investigate the ability of new host markers to differentiate between LTBI and active TB, levels of 29 biomarkers in QFT supernatants were evaluated using a Luminex multiplex cytokine assay.

Results

Eight out of 29 biomarkers distinguished active TB from LTBI in a pilot study. Baseline levels of epidermal growth factor (EGF) soluble CD40 ligand (sCD40L), antigen stimulated levels of EGF, and the background corrected antigen stimulated levels of EGF and macrophage inflammatory protein (MIP)-1β were the most informative single markers for differentiation between TB disease and LTBI, with AUCs of 0.88, 0.84, 0.87, 0.90 and 0.79 respectively. The combination of EGF and MIP-1β predicted 96% of active TB cases and 92% of LTBIs. Combinations between EGF, sCD40L, VEGF, TGF-α and IL-1α also showed potential to differentiate between TB infection states. EGF, VEGF, TGF-α and sCD40L levels were higher in TB patients.

Conclusion

These preliminary data suggest that active TB may be accurately differentiated from LTBI utilizing adaptations of the commercial QFT test that includes measurement of EGF, sCD40L, MIP-1β, VEGF, TGF-α or IL-1α in supernatants from QFT assays. This approach holds promise for development as a rapid diagnostic test for active TB.     

Changes in body composition in obese patients on a low-calorie diet

Energy balance was studied on 4 obese hospitalized subjects kept on hypocaloric diet (489 Kcal - 54% CHO, 10,6% Fat, 35,4% Protein) for 18 +/- 3,7 days. Energy expenditure was measured trough heart-rate monitoring (individual calibrations before and after the study were performed) and nitrogen balance was computed to establish protein loss. Individual qualitative composition of body weight loss was then assessed: 71,4 +/- 5,23% could be attributable to fat loss, 9,38 +/- 3,32% to protein loss, 18,2 +/- 5,5% to water loss. Part of this last figure could be attributable to a slight under-estimation of the method utilized to measure the energy expenditure (heart-rate monitoring).     

Changes in the species composition of a Karoo avifauna over time: a case study from Deelfontein,South Africa

A collection of almost 830 specimens of birds and their eggs was made at Deelfontein, Northern Cape province, South Africa, in 1901 and 1902, by two soldiers who had enlisted in the Yeomanry during the South African (Boer) War. A total of 151 bird species has been recorded in the Deelfontein area in two periods, 1901–1902 and 1987–1992. There has been no apparent change in occurrence in 82 species, but 40 species were recorded only in 1901–1902, and 29 species were recorded only by observers who completed field cards for the area for the SABAP surveys in 1987–1992. It is suggested that the differences in bird species composition are most likely associated with anthropogenic influences including land-use changes and over-utilisation of shrublands as grazing for domestic livestock.     

Longitudinal body composition data in exclusively breast-fed infants: a multicenter study

Reference %fat and total fat-free mass data is necessary for evaluating growth in infants. We aimed to develop longitudinal %fat and total fat-free mass data in infants from birth to 6 months of age. An observational, multicenter, prospective cohort study was conducted with assessments at birth, 1 week, 2 weeks, 1, 2, 3, 4, 5, and 6 months of age. Subjects were exclusively breast-fed and were enrolled at three centers. Whole-body composition (i.e., % fat and total fat-free mass) were assessed using air-displacement plethysmography (ADP) (PEA POD; Life Measurement, Concord, CA). Maternal prepregnancy BMI, gestational weight gain, and infant anthropometric data were collected. A total of 160 infants (boys = 84) were assessed from birth to 4 months of age. Mean birth weight was 3.46 ± 0.39 kg % fat and fat-free mass significantly increased from birth to 4 months of age (P < 0.0001). Gender-specific %fat and total fat-free mass curves for infants from birth to 4 months of age were created. This study will be beneficial to health-care professionals in evaluating normal growth and nutritional patterns in the first months of life.     

The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomized controlled trial

ABSTRACT: BACKGROUND: One of the main causes of mortality and morbidity following subarachnoid haemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, to date no effective treatment of vasospasm exists. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries and a recent pilot trial showed positive effect on cerebral vasospasm in a clinical setting. No randomised, clinical trials have been conducted, investigating the possible pharmacodynamic effects of prostacyclin on the human brain following SAH. METHODS: This trial is a single-center, randomised, placebo controlled, parallel group, blinded, clinical, pilot trial. A total of 90 patients with SAH will be randomised to one of 3 intervention arms; epoprostenol 1 ng/kg/min, epoprostenol 2 ng/kg/min or placebo in addition to standard treatment. Trial medication will start day 5 after SAH and continue to day 10. Primary outcome measure is changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery, measured by CT perfusion scan. The secondary outcomes will be vasospasm measured by CT angiography, ischaemic parameters measured by brain microdialysis, flow velocities in the medial cerebral artery, clinical parameters and outcome (Glasgow Outcome Scale) at 3 months. CONCLUSION: The trial is an explorative, pilot trial designed to investigate the feasibility and possible effects of low-dose prostacyclin on a primary outcome of regional blood flow and vasospasm in the human brain following SAH. Trial registration: Clinicaltrials.gov NCT01447095.     

Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial

This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.     

The submerged macrophytes in Lake Maarsseveen I: Changes in species composition and biomass over a six year period

The submerged macrophytes of Lake Maarsseveen I were surveyed in 1983 using SCUBA diving techniques. Only 40% of the characeans and 75% of the angiosperms detected in 1977 remained. The area colonized by submerged macrophytes was 0.45% in 1983, compared with 25.10% in 1977. The observed decreases were largely attributable to a shift of the plantcolonized areas to shallower depths. By 1983, most of the earlier predominant vegetation types had disappeared and the biomass had decreased. The decline in submerged vegetation may be attributed to increasing eutrophication, fish populations and recreational activities.