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1.
Heliyon ; 10(9): e30280, 2024 May 15.
Article En | MEDLINE | ID: mdl-38707422

A methodology for the mapping of residual stresses in metal alloys has been developed by analyzing an isotropic and homogeneous Al2024 alloy with scanning transmission electron microscopy (STEM), combined with diffraction (4DSTEM) and electron energy loss spectroscopy (STEM-EELS) techniques of TEM. The investigations on the alloy's microstructure and elemental distributions were also carried out with conventional dark-field STEM (DFSTEM) and X-ray energy dispersive (EDS) techniques, respectively. Using the STEM-EELS technique, the Young's modulus (YM) is mapped in the (001) plane of the Al alloy in the same regions where the residual strain maps are generated in [1‾ 00] and [010] directions by using 4DSTEM technique. The YM vs. residual strain plot for the Al 2024 alloy revealed that the value of YM decreased by about ∼ 7 % after the tensile residual strain reached 0.02 %. Whereas such a decrease in YM happens after the compressively residual strain reaches -0.015 %. The residual stress maps were also obtained in accordance with the Hooke's law i.e., by multiplying YM map with the corresponding residual strain maps.

2.
Polymers (Basel) ; 15(23)2023 Nov 21.
Article En | MEDLINE | ID: mdl-38231958

Friction stir lap welding (FSLW) remains a pioneering technique for creating hybrid joints between AA5052 aluminium alloy and polypropylene (PP), particularly with the metal-on-top configuration. Building upon previous research, this study introduces a tapered fluted pin tool design and investigates its effectiveness in the welding process. Our results, supported by ANOVA, chemical, and microstructural analyses, reiterate that the optimal welding parameters stand at a rotational speed of 1400 RPM and a traverse speed of 20 mm/min. This combination produces a joint tensile strength of 3.8 MPa, signifying 16.54% of the weaker material's inherent strength. Microstructural evaluations revealed a unique composite of aluminium chips intermeshed with PP, strengthened further by aluminium hooks. Crucially, mechanical interlocking plays a predominant role over chemical bonding in achieving this joint strength. The study underscores the absence of significant C-O-Al bonds, hinting at the PP degradation without the thermo-oxidation process. Additionally, joint strength was found to inversely correlate with the interaction layer's thickness. The findings fortify the promise of FSLW with the novel fluted pin design for enhancing joints between AA5052 and PP, emphasising the potential of mechanical interlocking as a principal factor in achieving high-quality welds.

3.
Materials (Basel) ; 15(20)2022 Oct 11.
Article En | MEDLINE | ID: mdl-36295118

Considering that the machining of composites particularly fiber-reinforced polymer composites (FRPCs) has remained a challenge associated with their heterogeneity and anisotropic nature, damage caused by drilling operations can be considerably mitigated by following optimum cutting parameters. In this work, we numerically evaluated the effects of cutting parameters, such as feed rate and spindle speed, on the thrust force and torque during the drilling of glass-fiber-reinforced polymers (GFRPs). A meso-scale, also known as unidirectional ply-level-based finite element modeling, was employed assuming an individual homogenized lamina with transversely isotropic material principal directions. To initiate the meso-scale damage in each lamina, 3D formulations of Hashin's failure theory were used for fiber damage and Puck's failure theory was implemented for matrix damage onset via user subroutine VUMAT in ABAQUS. The developed model accounted for the complex kinematics taking place at the drill-workpiece interface and accurately predicted the thrust force and torque profiles as compared with the experimental results. The thrust forces for various drilling parameters were predicted with a maximum of 10% error as compared with the experimental results. It was found that a combination of lower feed rates and higher spindle speeds reduced the thrust force, which in turn minimized the drilling-induced damage, thus providing useful guidelines for drilling operations with higher-quality products. Finally, the effect of coefficient of friction was also investigated. Accordingly, a higher coefficient of friction between the workpiece and drill-bit reduced the thrust force.

4.
Polymers (Basel) ; 14(3)2022 Feb 05.
Article En | MEDLINE | ID: mdl-35160607

Three-dimensional printed polymeric lattice structures have recently gained interests in several engineering applications owing to their excellent properties such as low-density, energy absorption, strength-to-weight ratio, and damping performance. Three-dimensional (3D) lattice structure properties are governed by the topology of the microstructure and the base material that can be tailored to meet the application requirement. In this study, the effect of architected structural member geometry and base material on the viscoelastic response of 3D printed lattice structure has been investigated. The simple cubic lattice structures based on plate-, truss-, and shell-type structural members were used to describe the topology of the cellular solid. The proposed lattice structures were fabricated with two materials, i.e., PLA and ABS using the material extrusion (MEX) process. The quasi-static compression response of lattice structures was investigated, and mechanical properties were obtained. Then, the creep, relaxation and cyclic viscoelastic response of the lattice structure were characterized. Both material and topologies were observed to affect the mechanical properties and time-dependent behavior of lattice structure. Plate-based lattices were found to possess highest stiffness, while the highest viscoelastic behavior belongs to shell-based lattices. Among the studied lattice structures, we found that the plate-lattice is the best candidate to use as a creep-resistant LS and shell-based lattice is ideal for damping applications under quasi-static loading conditions. The proposed analysis approach is a step forward toward understanding the viscoelastic tolerance design of lattice structures.

5.
Polymers (Basel) ; 13(22)2021 Nov 10.
Article En | MEDLINE | ID: mdl-34833180

In this work, three novel re-entrant plate lattice structures (LSs) have been designed by transforming conventional truss-based lattices into hybrid-plate based lattices, namely, flat-plate modified auxetic (FPMA), vintile (FPV), and tesseract (FPT). Additive manufacturing based on stereolithography (SLA) technology was utilized to fabricate the tensile, compressive, and LS specimens with different relative densities (ρ). The base material's mechanical properties obtained through mechanical testing were used in a finite element-based numerical homogenization analysis to study the elastic anisotropy of the LSs. Both the FPV and FPMA showed anisotropic behavior; however, the FPT showed cubic symmetry. The universal anisotropic index was found highest for FPV and lowest for FPMA, and it followed the power-law dependence of ρ. The quasi-static compressive response of the LSs was investigated. The Gibson-Ashby power law (≈ρn) analysis revealed that the FPMA's Young's modulus was the highest with a mixed bending-stretching behavior (≈ρ1.30), the FPV showed a bending-dominated behavior (≈ρ3.59), and the FPT showed a stretching-dominated behavior (≈ρ1.15). Excellent mechanical properties along with superior energy absorption capabilities were observed, with the FPT showing a specific energy absorption of 4.5 J/g, surpassing most reported lattices while having a far lower density.

6.
ACS Biomater Sci Eng ; 7(12): 5810-5822, 2021 12 13.
Article En | MEDLINE | ID: mdl-34802227

There is a growing need to develop novel well-characterized biological inks (bioinks) that are customizable for three-dimensional (3D) bioprinting of specific tissue types. Gelatin methacryloyl (GelMA) is one such candidate bioink due to its biocompatibility and tunable mechanical properties. Currently, only low-concentration GelMA hydrogels (≤5% w/v) are suitable as cell-laden bioinks, allowing high cell viability, elongation, and migration. Yet, they offer poor printability. Herein, we optimize GelMA bioinks in terms of concentration and cross-linking time for improved skeletal muscle C2C12 cell spreading in 3D, and we augment these by adding gold nanoparticles (AuNPs) or a two-dimensional (2D) transition metal carbide (MXene nanosheets) for enhanced printability and biological properties. AuNP and MXene addition endowed GelMA with increased conductivity (up to 0.8 ± 0.07 and 0.9 ± 0.12 S/m, respectively, compared to 0.3 ± 0.06 S/m for pure GelMA). Furthermore, it resulted in an improvement of rheological properties and printability, specifically at 10 °C. Improvements in electrical and rheological properties led to enhanced differentiation of encapsulated myoblasts and allowed for printing highly viable (97%) stable constructs. Taken together, these results constitute a significant step toward fabrication of 3D conductive tissue constructs with physiological relevance.


Metal Nanoparticles , Nanocomposites , Gelatin , Gold , Methacrylates , Muscle, Skeletal , Tissue Engineering , Tissue Scaffolds
7.
Polymers (Basel) ; 13(16)2021 Aug 23.
Article En | MEDLINE | ID: mdl-34451370

Thermomechanical modeling of epoxy/graphene oxide under quasi-static and dynamic loading requires thermo-mechanical properties such as Young's modulus, Poisson's ratio, thermal conductivity, and frequency-temperature dependent viscoelastic properties. In this study, the effects of different graphene oxide (GO) concentrations (0.05, 0.1, and 0.2 wt%) within an epoxy matrix on several mechanical and thermal properties were investigated. The distribution of GO fillers in the epoxy was investigated using transmission electron microscopy (TEM). The digital image correlation (DIC) technique was employed during the tensile testing to determine Young's modulus and Poisson's ratio. Analytical models were used to predict Young's modulus and thermal conductivity, with an error of less than 13% and 9%, respectively. Frequency-temperature dependent phenomenological models were proposed to predict the storage moduli and loss tangent, with a reasonable agreement with experimental data. A relatively high storage modulus, heat-resistance index (THRI), and thermal conductivity were observed in 0.2 wt% nanocomposite samples compared with pure epoxy and other lower concentration GO nanocomposites. A high THRI and derivative of thermogravimetric analysis peak temperatures (Tm1 and Tm2) were exhibited by adding nano-fillers in the epoxy, which confirms higher thermal stability of nanocomposites than that of pristine epoxy.

8.
Sensors (Basel) ; 20(23)2020 Nov 30.
Article En | MEDLINE | ID: mdl-33266048

Accurate damage detection in engineering structures is a critical part of structural health monitoring. A variety of non-destructive inspection methods has been employed to detect the presence and severity of the damage. In this research, machine learning (ML) algorithms are used to assess the dynamic response of the system. It can predict the damage severity, damage location, and fundamental behaviour of the system. Fatigue damage data of aluminium and ABS under coupled mechanical loads at different temperatures are used to train the model. The model shows that natural frequency and temperature appear to be the most important predictive features for aluminium. It appears to be dominated by natural frequency and tip amplitude for ABS. The results also show that the position of the crack along the specimen appears to be of little importance for either material, allowing simultaneous prediction of location and damage severity.

9.
Polymers (Basel) ; 11(12)2019 Dec 12.
Article En | MEDLINE | ID: mdl-31842417

Acrylonitrile butadiene styrene (ABS) offers good mechanical properties and is effective in use to make polymeric structures for industrial applications. It is one of the most common raw material used for printing structures with fused deposition modeling (FDM). However, most of its properties and behavior are known under quasi-static loading conditions. These are suitable to design ABS structures for applications that are operated under static or dead loads. Still, comprehensive research is required to determine the properties and behavior of ABS structures under dynamic loads, especially in the presence of temperature more than the ambient. The presented research was an effort mainly to provide any evidence about the structural behavior and damage resistance of ABS material if operated under dynamic load conditions coupled with relatively high-temperature values. A non-prismatic fixed-free cantilever ABS beam was used in this study. The beam specimens were manufactured with a 3D printer based on FDM. A total of 190 specimens were tested with a combination of different temperatures, initial seeded damage or crack, and crack location values. The structural dynamic response, crack propagation, crack depth quantification, and their changes due to applied temperature were investigated by using analytical, numerical, and experimental approaches. In experiments, a combination of the modal exciter and heat mats was used to apply the dynamic loads on the beam structure with different temperature values. The response measurement and crack propagation behavior were monitored with the instrumentation, including a 200× microscope, accelerometer, and a laser vibrometer. The obtained findings could be used as an in-situ damage assessment tool to predict crack depth in an ABS beam as a function of dynamic response and applied temperature.

10.
Health Technol Assess ; 21(1): 1-180, 2017 01.
Article En | MEDLINE | ID: mdl-28059054

BACKGROUND: Effective programmes to help children manage their weight are required. 'Families for Health' focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. OBJECTIVE: The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). DESIGN: The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. SETTING: Three sites in the West Midlands, England, UK. PARTICIPANTS: Children aged 6-11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. INTERVENTIONS: Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. MAIN OUTCOME MEASURES: Joint primary outcome measures were change in children's BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months' follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. RESULTS: The study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the 'usual-care' control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) -0.001 to 0.229; p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (-0.118, 95% CI -0.203 to -0.034; p = 0.007), but not in the Families for Health arm (-0.005, 95% CI -0.085 to 0.078; p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548; p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators', parents' and children's experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. CONCLUSIONS: Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6-11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45032201. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.


Health Promotion/organization & administration , Life Style , Parenting , Parents/education , Pediatric Obesity/therapy , Body Mass Index , Body Weights and Measures , Child , Cost-Benefit Analysis , Diet , Exercise , Family Health , Female , Health Behavior , Health Promotion/economics , Humans , Male , Mental Health , Models, Econometric , Parent-Child Relations , Pilot Projects , Quality of Life , Quality-Adjusted Life Years , Single-Blind Method , State Medicine/economics , United Kingdom
11.
Pharmacoeconomics ; 35(5): 549-559, 2017 May.
Article En | MEDLINE | ID: mdl-28063083

INTRODUCTION: Mapping algorithms are increasingly being used to predict health-utility values based on responses or scores from non-preference-based measures, thereby informing economic evaluations. OBJECTIVES: We explored whether predictions in the EuroQol 5-dimension 3-level instrument (EQ-5D-3L) health-utility gains from mapping algorithms might differ if estimated using differenced versus raw scores, using the Roland-Morris Disability Questionnaire (RMQ), a widely used health status measure for low back pain, as an example. METHODS: We estimated algorithms mapping within-person changes in RMQ scores to changes in EQ-5D-3L health utilities using data from two clinical trials with repeated observations. We also used logistic regression models to estimate response mapping algorithms from these data to predict within-person changes in responses to each EQ-5D-3L dimension from changes in RMQ scores. Predicted health-utility gains from these mappings were compared with predictions based on raw RMQ data. RESULTS: Using differenced scores reduced the predicted health-utility gain from a unit decrease in RMQ score from 0.037 (standard error [SE] 0.001) to 0.020 (SE 0.002). Analysis of response mapping data suggests that the use of differenced data reduces the predicted impact of reducing RMQ scores across EQ-5D-3L dimensions and that patients can experience health-utility gains on the EQ-5D-3L 'usual activity' dimension independent from improvements captured by the RMQ. CONCLUSION: Mappings based on raw RMQ data overestimate the EQ-5D-3L health utility gains from interventions that reduce RMQ scores. Where possible, mapping algorithms should reflect within-person changes in health outcome and be estimated from datasets containing repeated observations if they are to be used to estimate incremental health-utility gains.


Algorithms , Low Back Pain/diagnosis , Quality of Life , Quality-Adjusted Life Years , Adult , Female , Health Status , Humans , Low Back Pain/economics , Low Back Pain/physiopathology , Male , Middle Aged , Surveys and Questionnaires
12.
Arch Dis Child ; 102(5): 416-426, 2017 May.
Article En | MEDLINE | ID: mdl-28003178

OBJECTIVE: Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). DESIGN: Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. SETTING: Three National Health Service Primary Care Trusts in West Midlands, England. PARTICIPANTS: Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. INTERVENTIONS: FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. MAIN OUTCOME MEASURES: Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. RESULTS: 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. CONCLUSIONS: FFH was neither effective nor cost-effective for the management of obesity compared with UC. TRIAL REGISTRATION NUMBER: ISRCTN45032201.


Child Health Services/organization & administration , Family Health , Obesity/therapy , Parenting , Anthropometry/methods , Body Mass Index , Child , Child Health Services/economics , Cost-Benefit Analysis , Diet/statistics & numerical data , England , Feeding Behavior , Female , Health Promotion/economics , Health Promotion/organization & administration , Humans , Life Style , Male , Obesity/economics , Outcome Assessment, Health Care/methods , Parent-Child Relations , Quality of Life , Single-Blind Method , Social Class
13.
Value Health ; 17(6): 686-95, 2014 Sep.
Article En | MEDLINE | ID: mdl-25236992

OBJECTIVES: The Roland Morris Questionnaire (RMQ) is a widely used health status measure for low back pain (LBP). It is not preference-based, and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures. Using data from randomized controlled trials of treatment for LBP, we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire (EQ-5D) or the six-dimensional health state short form (derived from Medical Outcomes Study 36-Item Short-Form Health Survey) (SF-6D). METHODS: This study is based on data from the Back Skills Training Trial in which data were collected from 701 patients at baseline and subsequently at 3, 6, and 12 months postrandomization using a range of outcome measures, including the RMQ, the EQ-5D, and the Short Form 12 item Health Survey (SF-12) (from which SF-6D utilities can be derived). We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-5D and SF-6D health utilities and dimension responses. A multistage model selection process was used to assess the predictive accuracy of the models. We then explored different techniques and mapping models that made use of repeated follow-up observations in the data. The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial. RESULTS: A number of models were developed that accurately predict health utilities in this context. The best performing model for RMQ to EQ-5D mapping was a beta regression with Bayesian quasi-likelihood estimation that included 24 dummy variables for RMQ responses, age, and sex as covariates (mean squared error 0.0380) based on repeated data. The model selected for RMQ to SF-6D mapping was a finite mixture model that included the overall RMQ score, age, sex, RMQ score squared, age squared, and an interaction term for age and RMQ score as covariates (mean squared error 0.0114) based on repeated data. CONCLUSIONS: It is possible to reasonably predict EQ-5D and SF-6D health utilities from RMQ scores and responses using regression methods. Our regression equations provide an empirical basis for estimating health utilities when EQ-5D or SF-6D data are not available. They can be used to inform future economic evaluations of interventions targeting LBP.


Low Back Pain/diagnosis , Low Back Pain/epidemiology , Patient Preference , Surveys and Questionnaires/standards , Adult , Aged , Female , Humans , Low Back Pain/therapy , Male , Middle Aged
14.
Pharmacoeconomics ; 32(7): 693-706, 2014 Jul.
Article En | MEDLINE | ID: mdl-24715604

PURPOSE: The Pediatric Quality of Life Inventory™ (PedsQL™) General Core Scales (GCS) were designed to provide a modular approach to measuring health-related quality of life in healthy children, as well as those with acute and chronic health conditions, across the broadest, empirically feasible, age groups (2-18 years). Currently, it is not possible to estimate health utilities based on the PedsQL™ GCS, either directly or indirectly. This paper assesses different mapping methods for estimating EQ-5D health utilities from PedsQL™ GCS responses. METHODS: This study is based on data from a cross-sectional survey conducted in four secondary schools in England amongst children aged 11-15 years. We estimate models using both direct and response mapping approaches to predict EQ-5D health utilities and responses. The mean squared error (MSE) and mean absolute error (MAE) were used to assess the predictive accuracy of the models. The models were internally validated on an estimation dataset that included complete PedsQL™ GCS and EQ-5D scores for 559 respondents. Validation was also performed making use of separate data for 337 respondents. RESULTS: Ordinary least squares (OLS) models that used the PedsQL™ GCS subscale scores, their squared terms and interactions (with and without age and gender) to predict EQ-5D health utilities had the best prediction accuracy. In the external validation sample, the OLS model with age and gender had a MSE (MAE) of 0.036 (0.115) compared with a MSE (MAE) of 0.036 (0.114) for the OLS model without age and gender. However, both models generated higher prediction errors for children in poorer health states (EQ-5D utility score <0.6). The response mapping models encountered some estimation problems because of insufficient data for some of the response levels. CONCLUSION: Our mapping algorithms provide an empirical basis for estimating health utilities in childhood when EQ-5D data are not available; they can be used to inform future economic evaluations of paediatric interventions. They are likely to be robust for populations comparable to our own (children aged 11-15 years in attendance at secondary school). The performance of these algorithms in childhood populations, which differ according to age or clinical characteristics to our own, remains to be evaluated.


Health Status Indicators , Models, Theoretical , Quality of Life , Surveys and Questionnaires , Adolescent , Algorithms , Cross-Sectional Studies , England , Female , Humans , Least-Squares Analysis , Male , Psychometrics , Regression Analysis
15.
Trials ; 14: 81, 2013 Mar 20.
Article En | MEDLINE | ID: mdl-23514100

BACKGROUND: Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base. METHODS/DESIGN: This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children's BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style will also be assessed.Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. DISCUSSION: This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. TRIAL REGISTRATION: Current Controlled Trials http://ISRCTN45032201.


Child Health Services/economics , Health Care Costs , Obesity/therapy , Parenting , Research Design , Risk Reduction Behavior , Age Factors , Body Mass Index , Child , Clinical Protocols , Cost-Benefit Analysis , Diet/adverse effects , England , Exercise , Feeding Behavior , House Calls , Humans , Mental Health , Obesity/diagnosis , Obesity/economics , Obesity/physiopathology , Obesity/psychology , Parent-Child Relations , Quality of Life , Quality-Adjusted Life Years , Time Factors , Treatment Outcome , Weight Loss
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