ObjectivesTo determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults.MethodsRandomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.ResultsThe 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months.ConclusionsDespite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.Trial RegistrationClinicalTrials.gov Identifier NCT01092364.https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3
Aims/hypothesis Insulin resistance (IR) improves with weight loss, but this response is heterogeneous. We hypothesised that metabolomic profiling would identify biomarkers predicting changes in IR with weight loss. Methods Targeted mass spectrometry-based profiling of 60 metabolites, plus biochemical assays of NEFA, β-hydroxybutyrate, ketones, insulin and glucose were performed in baseline and 6 month plasma samples from 500 participants who had lost ≥4 kg during Phase I of the Weight Loss Maintenance (WLM) trial. Homeostatic model assessment of insulin resistance (HOMA-IR) and change in HOMA-IR with weight loss (ΔHOMA-IR) were calculated. Principal components analysis (PCA) and mixed models adjusted for race, sex, baseline weight, and amount of weight loss were used; findings were validated in an independent cohort of patients (n=22). Results Mean weight loss was 8.67±4.28 kg; mean ΔHOMA-IR was −0.80±1.73, range −28.9 to 4.82). Baseline PCA-derived factor 3 (branched chain amino acids [BCAAs] and associated catabolites) correlated with baseline HOMA-IR (r=0.50, p<0.0001) and independently associated with ΔHOMA-IR (p<0.0001). ΔHOMA-IR increased in a linear fashion with increasing baseline factor 3 quartiles. Amount of weight loss was only modestly correlated with ΔHOMA-IR (r=0.24). These findings were validated in the independent cohort, with a factor composed of BCAAs and related metabolites predicting ΔHOMA-IR (p=0.007). Conclusions/interpretation A cluster of metabolites comprising BCAAs and related analytes predicts improvement in HOMA-IR independent of the amount of weight lost. These results may help identify individuals most likely to benefit from moderate weight loss and elucidate novel mechanisms of IR in obesity.
Introduction: Obesity treatment is less successful for socioeconomically disadvantaged populations, particularly when delivered in primary care. Digital health strategies can extend the reach of clinical obesity treatments to care settings serving patients at highest risk. Methods: Track was an effectiveness RCT of a 12-month digital weight-loss intervention, embedded within a community health center system. Participants were 351 adult patients (aged 21–65 years) with obesity and hypertension, diabetes, and hyperlipidemia. Patients were randomized to usual care (n = 175) or an intervention (n = 176) comprising app-based self-monitoring of behavior change goals with tailored feedback, a smart scale, dietitian-delivered counseling calls, and clinician counseling informed by app-generated recommendations, delivered via electronic health record. The primary outcome was 12-month weight change. Randomization began on June 18, 2013, final assessments were completed on September 10, 2015. Data analysis was conducted in 2016 and 2017. The trial retained 92% of usual care and 96% of intervention participants at 12 months. Results: The Track intervention produced larger weight losses relative to usual care at 6 months (net effect: −4.4 kg, 95% CI = −5.5, −3.3, p < 0.001) and 12 months (net effect: −3.8 kg, 95% CI = −5.0, −2.5, p < 0.001). Intervention participants were more likely to lose ≥ 5% of their baseline weight at 6 months (43% vs 6%, p < 0.001) and 12 months (40% vs 17%, p < 0.001). Intervention participants completing ≥ 80% of expected self-monitoring episodes (−3.5 kg); counseling calls (−3.0 kg); or self-weighing days (−4.4 kg) lost significantly more weight than less engaged intervention participants (all p < 0.01). Conclusions: A digital obesity treatment, integrated with health system resources, can produce clinically meaningful weight-loss outcomes among socioeconomically disadvantaged primary care patients with elevated cardiovascular disease risk. Trial registration: This study is registered at www.clinicaltrials.gov, NCT01827800.
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