CHECK: A randomized trial evaluating the efficacy and cost-effectiveness of home visitation in pediatric weight loss treatment.

BACKGROUND: Socioeconomically-disadvantaged households have a high prevalence of pediatric overweight/obesity, and also face barriers to accessing weight loss treatment in healthcare settings. Delivering family-based pediatric weight loss treatment in the home setting may enhance its efficacy by facilitating treatment attendance, enabling more tailored treatment recommendations informed by observations of the home environment, and increasing accountability. This paper describes the design of the Creating Health Environments for Chicago Kids (CHECK) Trial, which evaluates the efficacy, cost-effectiveness, and mechanisms of home visitation in family-based pediatric weight loss treatment for children in low-income households. DESIGN: CHECK is a two-arm, parallel group, randomized controlled trial that is enrolling N = 266 children, ages 6-12 y, who have overweight/obesity (BMI percentile ≥85) and live in a low-income household. Participants are randomized in a 1:1 ratio to either standard of care family-based weight loss treatment delivered in the home, or the identical intervention delivered in an academic medical center. The primary outcome is change in child BMI z-score from baseline to 12 months. Program delivery costs are rigorously documented to enable cost-effectiveness analyses from the societal and payer perspectives. Objectively-documented changes to the home environment and aspects of intervention delivery (e.g., hours of in-person contact received, quantity of behavioral goals set per session) will be tested as hypothesized treatment mechanisms. IMPLICATIONS: Findings will inform the design of future interventions, and treatment dissemination decisions by public health agencies and third-party payers. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03195790.

Factors Influencing Longitudinal Stair Climb Performance from Midlife to Early Late Life: The Study of Women's Health Across the Nation Chicago and Michigan Sites.

OBJECTIVES: To quantify the longitudinal change in stair climb performance (a measure indicative of both physical function and muscle power), determine whether physical activity is related to slower decline in performance, and to identify factors that modify the longitudinal change in performance among women from midlife to late life. DESIGN: Longitudinal cohort study with up to 15 study visits. SETTING: Two sites of the Study of Women's Health Across the Nation. PARTICIPANTS: Black (n=411) and white (N=419) women followed from median age 47.0 (44.6-49.6) to 62.0 (55.8-65.3) years. INTERVENTIONS: N/A. MEASUREMENTS: Performance on a stair climb test (ascend/descend 4 steps, 3 cycles) was timed. Physical activity (PA) was assessed using the Kaiser Physical Activity Survey (KPAS; possible range 0-15 points). Sociodemographic and health factors were assessed via self-report. BMI was calculated with measured height and weight. Mixed-effects regression modeled longitudinal change in stair climb performance. RESULTS: Average baseline stair climb time was 18.12 seconds (95% CI: 17.83-18.41), with 0.98% (95% CI: 0.84%-1.11%) annual slowing. In fully adjusted models, higher levels of PA were associated with faster stair climb times (2.09% faster per point higher, 95% CI: -2.87%- -1.30%), and black women had 5.22% (95% CI: 2.43%-8.01%) slower performance compared to white women. Smoking, financial strain, diabetes, osteoarthritis, fair/poor health, and stroke were associated with 3.36% (95% CI: 0.07%-6.65%), 7.56% (95% CI: 4.75%-10.37%), 8.40% (95% CI: 2.89%-13.92%), 8.46% (95% CI: 5.12%-11.79%), 9.16% (95% CI: 4.72%-13.60%), and 16.94% (95% CI: 5.37%-28.51%) slower performance, respectively. In separate models, higher BMI (per 1-unit), osteoarthritis, fair/poor health, and diabetes, were each associated with 0.06% (95% CI:0.04%-0.08%), 0.48% (95% CI:0.12%-0.84%), 0.81% (95% CI:0.35%-1.28%), and 0.84% (95% CI:0.22%-1.46%), additional slowing per year over time. CONCLUSION: Significant declines in function were evident as women transitioned from midlife to early late life. Declines were amplified by indicators of poor health, emphasizing the importance of health in midlife for promoting healthy aging.

Systematic review of paediatric weight management interventions delivered in the home setting.

To increase their accessibility, paediatric weight management interventions are increasingly designed to be delivered in the home setting by trained staff. This systematic review summarizes the available evidence for interventions featuring home visitation and identifies key gaps in the literature. PubMed, CINAHL, Cochrane and PsycINFO were searched for intervention studies that reported change in objectively measured adiposity outcomes in youth ages 2-18 years. Studies published between 1 January 1995 and 12 February 2016 were analysed. Of 15 eligible studies, nine reported that interventions with home visitation were either superior to a control/comparison condition or achieved significant within-subjects reductions in adiposity. Interventions in which professional staff (e.g. dietitians and exercise trainers) conducted home visits tended to be more efficacious than those delivered by paraprofessional or community-based staff, as were interventions with more frequent contact. Most studies were judged to have low or unclear risk of bias across various domains. As most studies compared interventions with home visits with less intensive and qualitatively different approaches, it remains unclear whether home visitation per se enhances weight loss efficacy. Overall, paediatric weight management interventions that feature home visitation are promising, but the incremental benefit of the home visitation treatment modality remains to be rigorously evaluated. © 2016 World Obesity.

Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial.

OBJECTIVE: Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression before a lifestyle weight loss intervention improves both weight loss and depression. DESIGN: In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.9 (s.d.: 10.8) years) were randomized to brief behavior therapy for depression treatment followed by a lifestyle intervention (BA) or a lifestyle intervention only (LI). Follow-up occurred at 6 and 12 months. Main outcome measures included weight loss and depression symptoms. RESULTS: Intention-to-treat analyses revealed both conditions lost significant weight, but no differences between conditions in weight change at 6 months (BA=-3.0%, s.e.=-0.65%; LI=-3.7%, s.e.=0.63%; P=0.48) or 12 months (BA=-2.6%, s.e.=0.77%; LI=-3.1%, s.e.=0.74%; P=0.72). However, the BA condition evidenced significantly greater improvement in Beck Depression Inventory-II scores relative to the LI condition at both 6 months (BA mean change=-12.5, s.d.=0.85; LI mean change=-9.2, s.d.=0.80, P=0.005) and 12 months (BA mean change=-12.6, s.d.=0.97; LI mean change=-9.9, s.d.=0.93; P=0.045). Participants who experienced depression remission by 6 months (61.2%) lost greater weight (mean=-4.31%; s.e.=0.052) than those who did not (39.7%; mean=-2.47%, s.e.=0.53; P=.001). CONCLUSION: Adding behavior therapy to a lifestyle intervention results in greater depression remission but does not improve weight loss within 1 year. Improvement in depression is associated with greater weight loss.

Secretion of antileucoprotease from a human lung tumor cell line.

Two human tumor cell lines were analyzed for the production of human antileucoprotease (ALP). One of them, a human squamous lung carcinoma cell line (HS-24) synthesized, as confirmed by Western blot analysis, high amounts of ALP in serum-free medium. The supernatant inhibited elastase, chymotrypsin and trypsin. Northern blot analysis with an 18-mer radiolabelled oligonucleotide, derived from an ALP specific cDNA clone, revealed a specific mRNA of about 700-800 nucleotides in HS-24 tumor cells. In contrast, a secondary human lung tumor cell line (SB-3), derived from the adrenal cortex, did not synthesize ALP when assayed under identical conditions. The supernatant inhibited only trypsin and chymotrypsin.

Prevention of metastatic spread by postoperative immunotherapy with virally modified autologous tumor cells. I. Parameters for optimal therapeutic effects.

Effective anti-metastatic therapy was achieved in a mouse tumor model by combining surgery with post-operative immunotherapy using virus-modified autologous tumor cells. No therapeutic effect was observed when using for immunotherapy the nonmodified autologous tumor ESb, which is only weakly immunogenic and highly metastatic. The viral modification was achieved by infecting the tumor with an avirulent strain of Newcastle disease virus (NDV), which led to expression of viral antigens and to an increase in the tumor cells' immunogenicity. Parameters which were of decisive influence for success or failure of therapy were the time of operation of the primary tumor and the dose of virus which was admixed to a standard dose of irradiated tumor cells. There was a low dose optimum of NDV at about 100 hemagglutinating units per 25 X 10(6) tumor cells. The therapeutic effect observed was less pronounced if the virus was given separately from the tumor cells. Post-operative immunotherapy with NDV-modified tumor cells had the following therapeutic effects: (1) disappearance of micrometastases from visceral organs as ascertained by a sensitive bioassay; (2) life prolongation in virtually all animals when compared to controls (operated only); (3) cures in about 50% of the treated animals. The possible mechanism of this therapeutic effect and its potential for clinical application are discussed.

Interaction of high or low metastatic related tumor lines with normal or lymphokine-activated syngeneic peritoneal macrophages: in vitro analysis of tumor cell binding and cytostasis.

Peritoneal macrophages from normal DBA/2 mice were found to bind significantly more cells of a syngeneic low metastatic lymphoma line (Eb) than cells of a high metastatic variant (ESb) derived therefrom. These differences were observed in three different assays, at 4 degrees C and at 37 degrees C, and at various ratios of macrophages to tumor cells. Upon co-culture with normal macrophages, a tumor cytostatic effect was consistently observed with Eb but not with ESb tumor cells. Further experiments indicated that macrophages exerted their growth inhibitory effect via direct tumor cell contact. Pre-treatment of tumor cells with neuraminidase or pre-treatment of macrophages with lens culinaris lectin increased the numbers of macrophages binding Eb and ESb tumor cells. Addition of D-galactose or D-mannose at 50 mM concentration led to an increase of tumor cell binding and tumor cytostatic activity. Taken together, these results suggest (i) that carbohydrates play a role in tumor cell recognition by macrophages and (ii) that the differences observed between Eb and ESb tumor cells may be due to differences in the expression of carbohydrates. Pre-activation of the macrophages by lymphokine(s) led to a short increase in their tumor cell binding capacity. Lymphokine activation resulted in a strong but also short-lived increase of tumor cytostatic potential. This was effective against both the low and the high metastatic tumor line.

Intermediate-sized filaments of the prekeratin type in myoepithelial cells.

Myoepithelial cells from mammary glands, the modified sweat glands of bovine muzzle, and salivary glands have been studied by electron microscopy and by immunofluorescence microscopy in frozen sections in an attempt to further characterize the type of intermediate-sized filaments present in these cells. Electron microscopy has shown that all myoepithelial cells contain extensive meshworks of intermediate-sized (7--11-nm) filaments, many of which are anchored at typical desmosomes or hemidesmosomes. The intermediate-sized filaments are also intimately associated with masses of contractile elements, identified as bundles of typical 5--6-nm microfilaments and with characteristically spaced dense bodies. This organization resembles that described for various smooth muscle cells. In immunofluorescence microscopy, using antibodies specific for the various classes of intermediate-sized filaments, the myoepithelial cells are strongly decorated by antibodies to prekeratin. They are not specifically stained by antibodies to vimentin, which stain mesenchymal cells, nor by antibodies to chick gizzard desmin, which decorate fibrils in smooth muscle Z bands and intercalated disks in skeletal and cardiac muscle of mammals. Myoepithelial cells are also strongly stained by antibodies to actin. The observations show (a) that the epithelial character, as indicated by the presence of intermediate-sized filaments of the prekeratin type, is maintained in the differentiated contractile myoepithelial cell, and (b) that desmin and desmin-containing filaments are not generally associated with musclelike cell specialization for contraction but are specific to myogenic differentiation. The data also suggest that in myoepithelial cells prekeratin filaments are arranged--and might function--in a manner similar to the desmin filaments in smooth muscle cells.

Identification and characterization of epithelial cells in mammalian tissues by immunofluorescence microscopy using antibodies to prekeratin.

The occurrence of intermediate-sized filaments containing prekeratin-like proteins ('cytokeratins') has been examined in various organs of rat and cow by electron microscopy and by immunofluorescence microscopy on frozen sections using antibodies to defined constitutive proteins of various types of intermediate-sized filaments (prekeratin, vimentin, desmin). Positive cytokeratin reaction and tonofilament-like structures have been observed in the following epithelia: epidermis; ductal, secretory, and myoepithelial cells of sweat glands; mammary gland duct; myoepithelial cells of lactating mammary gland; milk secreting cells of cow; ductal, secretory, and myoepithelial cells of various salivary glands; tongue mucosa; bile duct; excretory duct of pancreas; intestinal mucosa; urothelium; trachea; bronchi; thymus reticulum, including Hassall corpuscles; mesothelium; uterus; and ciliated cells of oviduct. None of the epithelial cells mentioned has shown significant reaction with antibodies to vimentin, the major component of the type of intermediate-sized filaments predominant in mesenchymal cells. The widespread, if not general occurrence of cytokeratin filaments in epithelial cells is emphasized, and it is proposed to use this specific structure as a criterion for true epithelial character or origin.