SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings.

BACKGROUND: The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. METHODS: The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). RESULTS: We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. CONCLUSIONS: To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component

An exploratory investigation of links between changes in adipokines and quality of life in individuals undergoing weight loss interventions: Possible implications for cancer research

Obesity has been linked to a wide spectrum of malignancies, with the strongest association demonstrated for endometrial cancer. Although the mechanisms are not yet entirely clear, a number of risk biomarkers have been proposed, including altered adipokines. Systemic levels of these adipose derived molecules have also been linked in prior research to self-reported quality of life (QOL). The study objective was to examine the hypothesis that adipokine changes during intentional weight loss may be associated with changes in QOL. Methods Fifty-two female participants were selected from two behavioral weight loss trials (SMART and PREFER) on the basis of achieving successful weight loss at 6 month assessment, availability of blood samples and completion of standard SF-36 QOL questionnaires. Levels of adiponectin, leptin, and resistin were measured using xMAP immunoassays. Changes in QOL were examined using linear regression models in relation to pre- and post-intervention changes in biomarker levels and BMI. Results Significant changes between pre- and post-intervention were observed for leptin. Controlling for baseline BMI, leptin was the only biomarker that predicted change in QOL (Physical Component Scale, PCS). Linear regression models demonstrated that leptin continued to be a significant predictor of change in PCS when other possible predictor variables were included in the model. Conclusions This study is among the first to demonstrate that changes in PCS may be regulated by levels of both metabolic variables and adipokines. An improved understanding of biological mechanisms associated with weight loss and the role of QOL may help guide preventive strategies for obesity-associated cancers. © 2014 Elsevier Inc

The Presence of Genetic Mutations at Key Loci Predicts Progression to Esophageal Adenocarcinoma in Barrett's Esophagus

Risk stratification in Barrett's esophagus (BE) is challenging. We evaluated the ability of a panel of genetic markers to predict progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). In this case-control study, we assessed a measure of genetic instability, the mutational load (ML), in predicting progression to HGD or EAC. Cases had nondysplastic BE or low-grade dysplasia (LGD) at baseline and developed HGD/EAC ≥1 year later. Controls were matched 2:1, had nondysplastic BE or LGD, and no progression at follow-up. Formalin-fixed, paraffin-embedded tissue was microdissected for the epithelium. Loss of heterozygosity (LOH) and microsatellite instability (MSI) were assessed. ML was calculated from derangements in 10 genomic loci. High-clonality LOH mutations were assigned a value of 1, low-clonality mutations were assigned a value of 0.5, and MSI 0.75 at the first loci, and 0.5 for additional loci. These values were summed to the ML. Receiver operator characteristic (ROC) curves were created. There were 69 patients (46 controls and 23 cases). Groups were similar in age, follow-up time, baseline histology, and the number of microdissected targets. Mean ML in pre-progression biopsies was higher in cases (2.21) than in controls (0.42; P <0.0001). Sensitivity was 100% at ML ≥0.5 and specificity was 96% at ML ≥1.5. Accuracy was highest at 89.9% for ML ≥1. ROC curves for ML ≥1 demonstrated an area under the curve (AUC) of 0.95. ML in pre-progression BE tissue predicts progression to HGD or EAC. Although further validation is necessary, ML may have utility as a biomarker in endoscopic surveillance of B

Health-related quality of life among participants in the SMART weight loss trial

Obesity has been associated with a decreased health-related quality of life (HRQoL); however, the association between weight change and HRQoL is unclear. This secondary analysis of the SMART (Self Monitoring And Recording using Technology) trial, a clinical trial of behavioral weight loss treatment, provides evidence that quality of life improves with weight loss. © 2012 Elsevier Inc

A Descriptive Study of Past Experiences with Weight-Loss Treatment

Background: Overweight and obesity affect more than 60% of the adult population in the United States. Most adults who are overweight have a history of previous weight-loss treatment. Exploring individuals' past experiences with weight-loss treatment may allow improvements to the current approach to treatment. Objective: To examine individuals' prior experiences with weight-loss treatment, their treatment preferences, and what they found to be most and least satisfying. Design: Cross-sectional descriptive study. Subjects/setting: Individuals (N=155) who had registered for a weight-loss study wait list and met standard criteria for a weight-loss program (aged 18 to 55 years and body mass index between 25 and 42). Methods: Questionnaire packets were mailed to participants. Statistical analyses performed: Descriptive analyses of the participants' past history with weight-loss treatment, treatment preference, self-efficacy, therapeutic efficacy, barriers to adherence to weight-loss treatment, barriers to healthy eating, and experiences associated with following a low-fat diet. Results: One hundred ten participants (71%) returned completed questionnaire packets. The sample (82% white, 84% female, aged 42.6±8.5 years, and body mass index 33.5±5.3) was representative of those who seek weight-loss treatment in research settings. Participants were, on average, aged 21.1±8.9 years when they first tried a weight-loss program; 96.3% had tried to lose weight since that first time. The two most frequently tried programs were doing it on their own (93.5%) and commercial programs (70.8%). Barriers included having trouble controlling what I eat when hungry (71.3%), difficulty motivating myself to eat appropriately (66.2%), and using food as a reward (59.3%). Preferred weight-loss regimens were doing it on their own (30.6%) and a research program (22.4%). Conclusions: Participants were not seeking their preferred treatment. These data can be used to improve weight-loss programs by tailoring programs to meet the needs and preferences of participants. © 2008 American Dietetic Association

Physical activity self-monitoring and weight loss: 6-month results of the SMART trial

Weight loss has been associated with higher physical activity (PA) levels and frequent dietary self-monitoring. Less is known about how PA self-monitoring affects adherence to PA goals, PA levels, and weight change. Methods: The SMART Trial is a clinical weight loss trial in which 210 overweight adults were randomized equally to one of three arms: 1) paper record (PR), 2) personal digital assistant with self-monitoring software (PDA), and 3) PDA with daily tailored feedback message (PDA + FB). PA self-monitoring and adherence to PA goals were based on entries in weekly submitted diaries. PA levels were measured via self-report by the past 6-month Modifiable Activity Questionnaire at baseline and 6 months. Results: Data are presented on 189 participants with complete 6-month PA data (84% female, 77% white, mean age = 47.3 ± 8.8 yr, mean body mass index = 34.1 ± 4.5 kg·m -2). Median PA level was 7.96 MET·h·wk -1 at baseline and 13.4 MET·h·wk -1 at 6 months, with significant PA increases in all three arms. PDA + FB arm had a higher mean number of weekly self-monitoring entries than the PR arm (3.4 vs 2.4, P = 0.003) and were more likely to maintain high (i.e., 100%) adherence to PA goals over time than the PDA (P = 0.02) or PR arms (P = 0.0003). Both PA self-monitoring and adherence to PA goals were related to higher PA levels at 6 months. A higher mean rate of PA self-monitoring was associated with a greater percentage of weight decrease (ρ = -0.49, P < 0.0001) at 6 months. Conclusions: PA self-monitoring and adherence to PA goals were more likely in participants in the PDA + FB arm and in turn predicted higher PA levels and weight loss. Copyright © 2011 by the American College of Sports Medicine