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Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial.

ABSTRACT: BACKGROUND:Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low-carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet. OBJECTIVE:This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers' WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks. METHODS:A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day. RESULTS:Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively. CONCLUSIONS:This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk. TRIAL REGISTRATION:ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/19053.

SUBMITTER: Locke SR

PROVIDER: S-EPMC7459429 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial.

Locke Sean R SR Falkenhain Kaja K Lowe Dylan A DA Lee Terry T Singer Joel J Weiss Ethan J EJ Little Jonathan P JP

JMIR research protocols 20200817 8

<h4>Background</h4>Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low-carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- an ...[more]

PMID: 32804087

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Project description:BackgroundSelf-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes.ObjectiveThis study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement.MethodsGoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ≥800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires.ResultsAt baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms.ConclusionsRegardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach.Trial registrationClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).

Project description:Approximately 50% of women gain excessive weight in pregnancy. Optimizing gestational weight gain is important for the short- and long-term health of the childbearing woman and her baby. Despite this, there is no recommendation for routine weighing in pregnancy, and weight is a topic that many maternity care providers avoid. Resource-intensive interventions have mainly targeted overweight and obese women with variable results. Few studies have examined the way that socioeconomic status might influence the effectiveness or acceptability of an intervention to participants. Given the scale of the problem of maternal weight gain, maternity services will be unlikely to sustain resource intensive interventions; therefore, innovative strategies are required to assist women to manage weight gain in pregnancy.The primary aim of the trial was to examine the effectiveness of the Eating4Two smartphone app in assisting women of all body mass index categories to optimize gestational weight gain. Secondary aims include comparing childbirth outcomes and satisfaction with antenatal care and examining the way that relative advantage and disadvantage might influence engagement with and acceptability of the intervention.This randomized controlled trial will randomize 1330 women to control or intervention groups in 3 regions of different socioeconomic status. Women will be recruited from clinical and social media sites. The intervention group will be provided with access to the Eating4Two mobile phone app which provides nutrition and dietary information specifically tailored for pregnancy, advice on food serving sizes, and a graph that illustrates women's weight change in relation to the range recommended by the Institute of Medicine. Women will be encouraged to use the app to prompt conversations with their maternity care providers about weight gain in pregnancy. The control group will receive routine antenatal care.Recruitment has commenced though the recruitment rate is slower than expected. Additional funds are required to employ research assistants and promote the study in an advertising campaign.Feasibility testing highlighted the inadequacy of the original recruitment strategy and the need to provide the app in both major platforms (Android and iOS). Smartphone technologies may offer an effective alternative to resource intensive strategies for assisting women to optimize weight gain in pregnancy.Australian New Zealand Clinical Trials Registry ACTRN12617000169347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371470 (Archived by WebCite at http://www.webcitation.org /6zDvgw5bo).RR1-10.2196/9920.

Project description:BackgroundThe months prior to elective surgery may present an opportunity for patients to initiate behavior changes that will simultaneously ready them for surgery and improve their overall health status. An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m2) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m2 as a cut-off for offering surgery in an effort to optimize outcomes.MethodsThe purpose of this multicenter randomized, controlled trial is to assess the feasibility and efficacy of a 12-week remote dietitian (RD) supervised dietary and physical activity weight loss intervention and mobile app for 60 patients with severe obesity prior to undergoing TJA. Intervention participants will receive access to a smartphone app and connect with an RD who will contact these participants weekly or bi-weekly via video calls for up to nine video calls. Together, participants and RDs will set goals for lifestyle modifications, and RDs will check on progress towards achieving these goals using in-app tools such as food logs and text messages between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI < 40 kg/m2 after 12 weeks. Individuals randomized to the control group will receive clinical standard of care, such as nutritionist and/or physical therapy referrals. Outcome and demographic data will be collected from blood serology, chart review, mobile app user data, pre- and postintervention surveys, and phone interviews. The primary outcome measure will be weight change from baseline. Secondary outcome measures will include percentage of patients eligible to undergo TJA, number of sessions completed with dietitians, self-reported global health status (PROMIS Global Health scale), self-reported joint-specific pain and function (Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)), and serologies such as hemoglobin A1c, total lymphocyte count, albumin, and transferrin. Qualitative responses transcribed from phone interviews about the intervention will also be analyzed.DiscussionThis will be the first study to assess pre-operative weight loss in patients with severe obesity anticipating orthopaedic surgery using an RD and mobile app intervention aimed at helping patients become eligible for TJA.Trial registrationRegistered on 1 April 2020 at Clincialtrials.gov. Trial number is NCT04330391 .

Project description:BACKGROUND:Few people successfully maintain lost weight over the longer term. Mobile phones have the potential to deliver weight loss management programs that can encourage self-monitoring while also providing some behavioral therapy to assist users in developing personal skills that may be necessary for improved longer term weight loss maintenance. OBJECTIVE:The aim of this study was to evaluate a program supporting weight maintenance, which uses a behaviorally based mobile phone app to manage weight, food, exercise, mood, and stress. METHODS:In a randomized controlled trial over 24 weeks, the full version of the app (MotiMate) was compared with a control app (monitoring only; excluding mood and stress) for its effect on weight, diet, and psychological well-being. Both apps had the same visual appearance and were designed to deliver all intervention content without face-to-face contact. The control version included features to track weight, food intake, and exercise with limited feedback and no encouraging/persuasive features. The intervention app included more persuasive and interactive features to help users track their weight, food intake, and physical activity and prompted users to enter data each day through notifications and included a mood and stress workshopping tool. Participants were recruited through advertising and existing databases. Clinic visits occurred at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. At all visits, the clinical trial manager recorded body weight, and participants then completed a computer-delivered survey, which measured psychological and lifestyle outcomes. Objective app usage data were recorded throughout the trial. RESULTS:A total of 88 adults who had lost and maintained at least 5% of their body weight within the last 2 years were randomized (45 MotiMate and 43 control). Overall, 75% (66/88) were female, and 69% (61/88) completed week 24 with no differences in dropout by condition (χ21,87=0.7, P=.49). Mixed models suggested no significant changes in weight or psychological outcomes over 24 weeks regardless of condition. Of 61 completers, 53% (32/61) remained within 2% of their starting weight. Significant increases occurred over 24 weeks for satisfaction with life and weight loss self-efficacy regardless of app condition. Diet and physical activity behaviors did not vary by app or week. Negative binomial models indicated that those receiving the full app remained active users of the app for 46 days longer than controls (P=.02). Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). CONCLUSIONS:Although some aspects of the intervention app such as usage and user feedback showed promise, there were few observable effects on behavioral and psychological outcomes. Future evaluation of the app should implement alternative research methods or target more specific populations to better understand the utility of the coping interface. TRIAL REGISTRATION:Australia New Zealand Clinical Trials Registry ACTRN12614000474651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366120.

Project description:ObjectivesMost electronically delivered lifestyle interventions are labor intensive, requiring logging onto websites and manually recording activity and diet. Cumbersome technology and lack of a human coach may have contributed to the limitations of prior interventions. In response, the current program of research created a comprehensive electronically delivered lifestyle intervention using a user-friendly, interactive, smartphone app-based model, and evaluated it in a randomized controlled trial.MethodsTwenty-eight adults, body mass index 25-42 kg/m2, with smartphones and sedentary jobs, were randomized to the intervention, along with conventional outpatient weight-management visits every 3 months, or to a wait-listed control group that received only weight-management visits. The intervention included wearable activity trackers, smartscales, food photography logs, physician-driven app-based behavioral coaching, and peer support via the app. The prespecified primary outcome was a comparison of change in weight in kilograms, in the intervention versus control group at 6 months.ResultsAt 6 months, the intervention group experienced a statistically significant weight change of -7.16 ± 1.78 kg (mean ± SE, 95% CI -11.05 to -3.26, p < 0.01), which differed from the weight change in controls by -4.16 ± 2.01 kg (95% CI -8.29 to -0.02, p < 0.05, prespecified primary outcome). Weight change in the control group was -3.00 ± 1.05 kg (95% CI -5.27 to -0.73, p < 0.05). Waist circumference and hemoglobin A1c significantly improved (intervention vs. control: p < 0.01, p < 0.05, respectively, prespecified secondary outcomes). Weight change in the intervention group correlated with numbers of food photographs participants shared (rho = -0.86, p < 0.01), numbers of their text messages (rho = -0.80, p < 0.01), number of times and days each participant stepped on the smartscale (rho = -0.73, p < 0.01; rho = -0.608, p < 0.05, respectively), and mean daily step counts (rho = -0.55, p < 0.05).ConclusionThis app-based electronically delivered lifestyle intervention produced statistically significant, clinically meaningful weight loss and improved metabolic health. Engagement with the intervention correlated strongly with weight loss. Given the limited sample size, larger and longer studies of this intervention are needed.

Project description:BackgroundAlthough calorie tracking is one of the strongest predictors of weight loss in behavioral weight loss interventions, low rates of adherence are common.ObjectiveThis study aims to examine the feasibility and acceptability of using the Slip Buddy app during a 12-week web-based weight loss program.MethodsWe conducted a randomized pilot trial to evaluate the feasibility and acceptability of using the Slip Buddy app compared with a popular commercial calorie tracking app during a counselor-led, web-based behavioral weight loss intervention. Adults who were overweight or obese were recruited on the web and randomized into a 12-week web-based weight loss intervention that included either the Slip Buddy app or a commercial calorie tracking app. Feasibility outcomes included retention, app use, usability, slips reported, and contextual factors reported at slips. Acceptability outcomes included ratings of how helpful, tedious, taxing, time consuming, and burdensome using the assigned app was. We described weight change from baseline to 12 weeks in both groups as an exploratory outcome. Participants using the Slip Buddy app provided feedback on how to improve it during the postintervention focus groups.ResultsA total of 75% (48/64) of the participants were female and, on average, 39.8 (SD 11.0) years old with a mean BMI of 34.2 (SD 4.9) kg/m2. Retention was high in both conditions, with 97% (31/32) retained in the Slip Buddy condition and 94% (30/32) retained in the calorie tracking condition. On average, participants used the Slip Buddy app on 53.8% (SD 31.3%) of days, which was not significantly different from those using the calorie tracking app (mean 57.5%, SD 28.4% of days), and participants who recorded slips (30/32, 94%) logged on average 17.9 (SD 14.4) slips in 12 weeks. The most common slips occurred during snack times (220/538, 40.9%). Slips most often occurred at home (297/538, 55.2%), while working (153/538, 28.4%), while socializing (130/538, 24.2%), or during screen time (123/538, 22.9%). The conditions did not differ in participants' ratings of how their assigned app was tedious, taxing, or time consuming (all values of P>.05), but the calorie tracking condition gave their app higher helpfulness and usability ratings (all values of P<.05). Technical issues were the most common type of negative feedback, whereas simplicity was the most common type of positive feedback. Weight losses of ≥5% of baseline weight were achieved by 31% (10/32) of Slip Buddy participants and 34% (11/32) of calorie tracking participants.ConclusionsSelf-monitoring of dietary lapses and the contextual factors associated with them may be an alternative for people who do not prefer calorie tracking. Future research should examine patient characteristics associated with adherence to different forms of dietary self-monitoring.Trial registrationClinicalTrials.gov NCT02615171; https://clinicaltrials.gov/ct2/show/NCT02615171.

Dataset Information

Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial.

Publications

Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial.

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