Effects of Calorie Restriction in Obese Older Adults: The CROSSROADS Randomized Controlled Trial

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Abstract

We lack a comprehensive assessment of the risks and benefits of calorie restriction in older adults at high risk for cardiometabolic disease. Calorie restriction may reduce visceral adipose tissue (VAT) but also have negative effects on lean mass and quality of life.

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Development of a brief measure to assess quality of life in obesity.

Jacy R. Crosby, Ronette Kolotkin, K Kosloski … (2001)

Obesity researchers have a growing interest in measuring the impact of weight and weight reduction on quality of life. The Impact of Weight on Quality of Life questionnaire (IWQOL) was the first self-report instrument specifically developed to assess the effect of obesity on quality of life. Although the IWQOL has demonstrated excellent psychometric properties, its length (74 items) makes it somewhat cumbersome as an outcome measure in clinical research. This report describes the development of a 31-item version of the IWQOL (IWQOL-Lite). IWQOLs from 996 obese patients and controls were used to develop the IWQOL-Lite. Psychometric properties of the IWQOL-Lite were examined in a separate cross-validation sample of 991 patients and controls. Confirmatory factor analysis provided strong support for the adequacy of the scale structure. The five identified scales of the IWQOL-Lite (Physical Function, Self-Esteem, Sexual Life, Public Distress, and Work) and the total IWQOL-Lite score demonstrated excellent psychometric properties. The reliability of the IWQOL-Lite scales ranged from 0.90 to 0.94 and was 0.96 for the total score. Correlations between the IWQOL-Lite and collateral measures supported the construct validity of the IWQOL-Lite. Changes in IWQOL-Lite scales over time correlated significantly with changes in weight, supporting its sensitivity to change. Significant differences in IWQOL-Lite scale and total scores were found among groups differing in body mass index, supporting the utility of the IWQOL-Lite across the body mass index spectrum. The IWQOL-Lite appears to be a psychometrically sound and clinically sensitive brief measure of quality of life in obese persons.

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The reliability and validity of a chair sit-and-reach test as a measure of hamstring flexibility in older adults.

Alison Jones, G Noffal, Roberta E Rikli … (1998)

The purpose of this study was to examine the test-retest reliability and the criterion validity of a newly developed chair sit-and-reach (CSR) test as a measure of hamstring flexibility in older adults CSR performance was also compared to sit-and-reach (SR) and back-saver sit-and-reach (BSR) measures of hamstring flexibility. To estimate reliability, 76 men and women (M age = 70.5 years) performed the CSR on 2 different days, 2-5 days apart. In the validity phase of the study, scores of 80 men and women (M age = 74.2 years) were obtained on three field test measures of hamstring flexibility (CSR, SR, and BSR) and on a criterion test (goniometer measurement of a passive straight-leg raise). Results indicate that the CSR has good intraclass test-retest reliability (R = .92 for men; r = .96 for women), and has a moderate-to-good relationship with the criterion measure (r = .76 for men; r = .81 for women). The criterion validity of the CSR for the male and female participants is comparable to that of the SR (r = .74 and r = .71, respectively) and BSR (r = .70 and r = .71, respectively). Results indicate that the CSR test produces reasonably accurate and stable measures of hamstring flexibility. In addition, it appears that the CSR is a safe and socially acceptable alternative to traditional floor sit-and-reach tests as a measure of hamstring flexibility in older adults.

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Missing Data in Randomized Clinical Trials for Weight Loss: Scope of the Problem, State of the Field, and Performance of Statistical Methods

Mai A. Elobeid, Miguel Padilla, Theresa McVie … (2009)

Background Dropouts and missing data are nearly-ubiquitous in obesity randomized controlled trails, threatening validity and generalizability of conclusions. Herein, we meta-analytically evaluate the extent of missing data, the frequency with which various analytic methods are employed to accommodate dropouts, and the performance of multiple statistical methods. Methodology/Principal Findings We searched PubMed and Cochrane databases (2000–2006) for articles published in English and manually searched bibliographic references. Articles of pharmaceutical randomized controlled trials with weight loss or weight gain prevention as major endpoints were included. Two authors independently reviewed each publication for inclusion. 121 articles met the inclusion criteria. Two authors independently extracted treatment, sample size, drop-out rates, study duration, and statistical method used to handle missing data from all articles and resolved disagreements by consensus. In the meta-analysis, drop-out rates were substantial with the survival (non-dropout) rates being approximated by an exponential decay curve (e−λt) where λ was estimated to be .0088 (95% bootstrap confidence interval: .0076 to .0100) and t represents time in weeks. The estimated drop-out rate at 1 year was 37%. Most studies used last observation carried forward as the primary analytic method to handle missing data. We also obtained 12 raw obesity randomized controlled trial datasets for empirical analyses. Analyses of raw randomized controlled trial data suggested that both mixed models and multiple imputation performed well, but that multiple imputation may be more robust when missing data are extensive. Conclusion/Significance Our analysis offers an equation for predictions of dropout rates useful for future study planning. Our raw data analyses suggests that multiple imputation is better than other methods for handling missing data in obesity randomized controlled trials, followed closely by mixed models. We suggest these methods supplant last observation carried forward as the primary method of analysis.