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Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

ABSTRACT: To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese.Multicentre randomized, controlled clinical trial.Primary health care centres in the city of Tarragona and surrounding areas.70 primary care patients, aged 18 years or older, with body mass index of 25 g/m2 or greater who wish to lose weight. Description of the intervention: 12 months of standard diet recommendations without (n = 35) or with (n = 35) assistance of a free Smartphone app that allows the participant to maintain a record of dietary intake and a bracelet monitor that records physical activity. The outcomes will be weight loss at 12 months (primary outcome), changes in physical activity and cardiometabolic risk factors, frequency of app use, and participant satisfaction after 12 months.The results of our study will offer evidence of the effectiveness of an intervention using one of the most popular free apps and wearable devices in achieving weight loss among patients who are overweight or obese. If these new technologies are proven effective in our population, they could be readily incorporated into primary care interventions promoting healthy weight. The open design and study characteristics make it impossible for the participants and researchers to be blinded to study group assignment. Researchers responsible for data analysis will be blinded to participant allocation.Clinical Register: NCT02417623. Registered 26 March 2015.

SUBMITTER: Granado-Font E

PROVIDER: S-EPMC4455326 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

Granado-Font Esther E Flores-Mateo Gemma G Sorlí-Aguilar Mar M Montaña-Carreras Xavier X Ferre-Grau Carme C Barrera-Uriarte Maria-Luisa ML Oriol-Colominas Eulàlia E Rey-Reñones Cristina C Caules Iolanda I Satué-Gracia Eva-María EM

BMC public health 20150604

<h4>Background</h4>To evaluate the effectiveness of an experimental intervention based on standard diet recommendations plus free Smartphone application (app) and wearable device for weight loss, compared with the standard diet intervention alone, in primary care patients aged 18 years or older who are overweight or obese.<h4>Methods/design</h4>Multicentre randomized, controlled clinical trial.<h4>Location</h4>Primary health care centres in the city of Tarragona and surrounding areas.<h4>Subject ...[more]

PMID: 26041131

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Project description:Many smartphone applications (apps) for weight loss are available, but little is known about their effectiveness.To evaluate the effect of introducing primary care patients to a free smartphone app for weight loss.Randomized, controlled trial. (ClinicalTrials.gov: NCT01650337).2 academic primary care clinics.212 primary care patients with body mass index of 25 kg/m2 or greater.6 months of usual care without (n = 107) or with (n = 105) assistance in downloading the MyFitnessPal app (MyFitnessPal).Weight loss at 6 months (primary outcome) and changes in systolic blood pressure and behaviors, frequency of app use, and satisfaction (secondary outcomes).After 6 months, weight change was minimal, with no difference between groups (mean between-group difference, -0.30 kg [95% CI, -1.50 to 0.95 kg]; P = 0.63). Change in systolic blood pressure also did not differ between groups (mean between-group difference, -1.7 mm Hg [CI, -7.1 to 3.8 mm Hg]; P = 0.55). Compared with patients in the control group, those in the intervention group increased use of a personal calorie goal (mean between-group difference, 2.0 d/wk [CI, 1.1 to 2.9 d/wk]; P < 0.001), although other self-reported behaviors did not differ between groups. Most users reported high satisfaction with MyFitnessPal, but logins decreased sharply after the first month.Despite being blinded to the name of the app, 14 control group participants (13%) used MyFitnessPal. In addition, 32% of intervention group participants and 19% of control group participants were lost to follow-up at 6 months. The app was given to patients by research assistants, not by physicians.Smartphone apps for weight loss may be useful for persons who are ready to self-monitor calories, but introducing a smartphone app is unlikely to produce substantial weight change for most patients.Robert Wood Johnson Foundation Clinical Scholars Program, National Institutes of Health/National Center for Advancing Translational Sciences for the UCLA Clinical and Translational Science Institute, and the Resource Centers for Minority Aging Research Center for Health Improvement of Minority Elderly under the National Institutes of Health/National Institute on Aging.

Project description:BackgroundAlthough there are many wearable devices available to help people lose weight and decrease the rising prevalence of obesity, the effectiveness of these devices in long-term weight management has not been established.ObjectiveThis study aimed to systematically review the literature on using wearable technology for long-term weight loss in overweight and obese adults.MethodsWe searched the following databases: Medical Literature Analysis and Retrieval System Online, EMBASE, Compendex, ScienceDirect, Cochrane Central, and Scopus. The inclusion criteria were studies that took measurements for a period of ?1 year (long-term) and had adult participants with a BMI >24. A total of 2 reviewers screened titles and abstracts and assessed the selected full-text papers for eligibility. The risk of bias assessment was performed using the following tools appropriate for different study types: the Cochrane risk of bias tool, Risk Of Bias In Nonrandomized Studies-of Interventions, A MeaSurement Tool to Assess systematic Reviews, and 6 questions to trigger critical thinking. The results of the studies have been provided in a narrative summary.ResultsWe included five intervention studies: four randomized controlled trials and one nonrandomized study. In addition, we used insights from six systematic reviews, four commentary papers, and a dissertation. The interventions delivered by wearable devices did not show a benefit over comparator interventions, but overweight and obese participants still lost weight over time. The included intervention studies were likely to suffer from bias. Significant variances in objectives, methods, and results of included studies prevented meta-analysis.ConclusionsThis review showed some evidence that wearable devices can improve long-term physical activity and weight loss outcomes, but there was not enough evidence to show a benefit over the comparator methods. A major issue is the challenge of separating the effect of decreasing use of wearable devices over time from the effect of the wearable devices on the outcomes. Consistency in study methods is needed in future long-term studies on the use of wearable devices for weight loss.Trial registrationPROSPERO CRD42018096932; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96932.

Project description:BackgroundObesity is an established and modifiable risk factor for urinary incontinence, but conclusive evidence for a beneficial effect of weight loss on urinary incontinence is lacking.MethodsWe randomly assigned 338 overweight and obese women with at least 10 urinary-incontinence episodes per week to an intensive 6-month weight-loss program that included diet, exercise, and behavior modification (226 patients) or to a structured education program (112 patients).ResultsThe mean (+/-SD) age of the participants was 53+/-11 years. The body-mass index (BMI) (the weight in kilograms divided by the square of the height in meters) and the weekly number of incontinence episodes as recorded in a 7-day diary of voiding were similar in the intervention group and the control group at baseline (BMI, 36+/-6 and 36+/-5, respectively; incontinence episodes, 24+/-18 and 24+/-16, respectively). The women in the intervention group had a mean weight loss of 8.0% (7.8 kg), as compared with 1.6% (1.5 kg) in the control group (P<0.001). After 6 months, the mean weekly number of incontinence episodes decreased by 47% in the intervention group, as compared with 28% in the control group (P=0.01). As compared with the control group, the intervention group had a greater decrease in the frequency of stress-incontinence episodes (P=0.02), but not of urge-incontinence episodes (P=0.14). A higher proportion of the intervention group than of the control group had a clinically relevant reduction of 70% or more in the frequency of all incontinence episodes (P<0.001), stress-incontinence episodes (P=0.009), and urge-incontinence episodes (P=0.04).ConclusionsA 6-month behavioral intervention targeting weight loss reduced the frequency of self-reported urinary-incontinence episodes among overweight and obese women as compared with a control group. A decrease in urinary incontinence may be another benefit among the extensive health improvements associated with moderate weight reduction. (ClinicalTrials.gov number, NCT00091988.)

Project description:This study compared the efficacy of two multi-component m-health interventions with a wait-list control group on body weight (primary outcome), and secondary outcomes of cardiovascular risk factors, lifestyle behaviours, and mental health. Three-arm randomised controlled trial (Enhanced: physical activity, diet, sleep, Traditional: physical activity, diet, Control) with assessments conducted at baseline, 6 and 12 months. Participants (n = 116) were overweight or obese adults aged 19-65 (M = 44.5 [SD = 10.5]). The 6-month intervention was delivered via a smartphone app providing educational materials, goal-setting, self-monitoring and feedback, and also included one face-to-face dietary consultation, a Fitbit and scales. The trial was prospectively registered and conducted between May 2017 and September 2018. Group differences on primary and secondary outcomes were examined between the Pooled Intervention groups (Pooled Intervention = Enhanced and Traditional) and Control groups, and then between Enhanced and Traditional groups. Nineteen participants (16.4%) formally withdrew from the trial. Compared with the Control group, average body weight of the Pooled Intervention group did not differ at 6 (between-group difference = -0.92, (95% CI -3.33, 1.48)) or 12 months (0.00, (95% CI -2.62, 2.62)). Compared with the Control group, the Pooled Intervention group significantly increased resistance training (OR = 7.83, (95% CI 1.08, 56.63)) and reduced energy intake at 6 months (-1037.03, (-2028.84, -45.22)), and improved insomnia symptoms at 12 months (-2.59, (-4.79, -0.39)). Compared with the Traditional group, the Enhanced group had increased waist circumferences (2.69, (0.20, 5.18)) and sedentary time at 6 months (105.66, (30.83, 180.48)), and improved bed time variability at 12 months (-1.08, (-1.86, -0.29)). No other significant differences were observed between groups. Relative to Controls, the Pooled Intervention groups did not differ on body weight but improved resistance training, and reduced energy intake and insomnia symptom severity. No additional weight loss was apparent when targeting improvements in physical activity, diet and sleep in combination compared with physical activity and diet.

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Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

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Effectiveness of a Smartphone application and wearable device for weight loss in overweight or obese primary care patients: protocol for a randomised controlled trial.

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