scholarly journals Comparing the Keyto App and Device with Weight Watchers’ WW App for Weight Loss: Protocol for a Randomized Trial

10.2196/19053 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e19053
Author(s):  
Sean R Locke ◽  
Kaja Falkenhain ◽  
Dylan A Lowe ◽  
Terry Lee ◽  
Joel Singer ◽  
...  

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

2020 ◽  
Author(s):  
Sean R Locke ◽  
Kaja Falkenhain ◽  
Dylan A Lowe ◽  
Terry Lee ◽  
Joel Singer ◽  
...  

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. CLINICALTRIAL ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19053


2006 ◽  
Vol 50 (2) ◽  
pp. 368-376 ◽  
Author(s):  
Maria Teresa Zanella ◽  
Marcelo Hiroshi Uehara ◽  
Artur Beltrame Ribeiro ◽  
Marcelo Bertolami ◽  
Ana Claudia Falsetti ◽  
...  

Weight loss improves metabolic abnormalities and reduces cardiovascular risk in obese hypertensive patients. To evaluate the impact of a sustained weight loss on coronary risk, 181 hypertensive patients with metabolic syndrome underwent to orlistat therapy, 120 mg, t.i.d., plus diet for 36 weeks. During therapy, Framingham risk scores (FRS) were calculated for determination of coronary heart disease risk in ten years. Body mass index decreased from 35.0 ± 4.2 to 32.6 ± 4.5 kg/m² (p< 0.0001) and waist circumference from 108.1 ± 10.1 to 100.5 ± 11.1 cm (p< 0.0001), at the end of the study period (week 36). Systolic and diastolic blood pressure showed reductions after the two first weeks, which were maintained up to the end of the study. A clear shift to the left in FRS distribution curve occurred at the end of the study, compared to baseline, indicating a reduction in coronary risk. Over all patients at risk, 49.2% moved to a lower risk category. A weight loss > 5% occurred in 64.6% of all patients, associated with improvement in glucose metabolism. Among those with abnormal glucose metabolism, 38 out 53 patients (71.7%) improved their glucose tolerance (p< 0.0005). In conclusion, long-term orlistat therapy helps to reduce and maintain a lower body weight, decreasing risk of coronary disease and improving glucose metabolism, thus protecting against type 2 diabetes.


2021 ◽  
pp. 1-37
Author(s):  
Laury Sellem ◽  
Bernard Srour ◽  
Kim G. Jackson ◽  
Serge Hercberg ◽  
Pilar Galan ◽  
...  

Abstract In France, dairy products contribute to dietary saturated fat intake, of which reduced consumption is often recommended for cardiovascular disease (CVD) prevention. Epidemiological evidence on the association between dairy consumption and CVD risk remains unclear, suggesting either null or inverse associations. This study aimed to investigate the associations between dairy consumption (overall and specific foods) and CVD risk in a large cohort of French adults. This prospective analysis included participants aged ≥ 18 years from the NutriNet-Santé cohort (2009–2019). Daily dietary intakes were collected using 24h-dietary records. Total dairy, milk, cheese, yogurts, fermented and reduced-fat dairy intakes were investigated. CVD cases (n=1,952) included cerebrovascular (n=878 cases) and coronary heart diseases (CHD, n=1,219 cases). Multivariable Cox models were performed to investigate associations. This analysis included n=104,805 French adults (mean age at baseline 42.8 years (SD 14.6)), mean follow-up 5.5 years (SD 3.0, i.e. 579,155 persons years). There were no significant associations between dairy intakes and total CVD or CHD risks. However, the consumption of at least 160 g/d of fermented dairy (e.g. cheese and yogurts) was associated with a reduced risk of cerebrovascular diseases compared to intakes below 57 g/d (HR=0.81 [0.66-0.98], p-trend=0.01). Despite being a major dietary source of saturated fats, dairy consumption was not associated with CVD or CHD risks in this study. However, fermented dairy was associated with a lower cerebrovascular disease risk. Robust randomized controlled trials are needed to further assess the impact of consuming different dairy foods on CVD risk and potential underlying mechanisms.


2017 ◽  
Vol 3 (1) ◽  
pp. 7-14
Author(s):  
Okon Ekwere Essien ◽  
Iya Eze Bassey ◽  
Rebecca Mtaku Gali ◽  
Alphonsus Ekpe Udoh ◽  
Uwem Okon Akpan ◽  
...  

Purpose Cardiovascular disease risk factors have been associated with androgen-deprivation therapy (ADT) in white and Hispanic populations. It is therefore relevant to determine if there exists a relationship between these parameters in the African population. Patients and Methods The design of the study was cross sectional. Prostate-specific antigen concentration, waist circumference, body mass index (BMI), lipid profile, glucose level, and insulin level were determined in 153 patients with prostate cancer and 80 controls. The patients with prostate cancer were divided into subgroups of treatment-naïve patients and those receiving ADT. Results Mean total cholesterol ( P = .010), LDL cholesterol ( P = .021), BMI ( P = .001), and waist circumference ( P = .029) values were significantly higher in patients treated with ADT when compared with treatment-naïve patients. In patients treated with ADT for up to 1 year, only mean BMI was significantly higher than in treatment-naïve patients, whereas those treated with ADT for more than 1 year had significantly higher mean BMI, waist circumference, total cholesterol, and LDL cholesterol values when compared with treatment-naïve patients. There were no significant differences in insulin or glucose levels. Those undergoing hormone manipulation after orchiectomy had fewer cardiovascular risk factors compared with those undergoing hormone manipulation alone. Conclusion This study shows that ADT results in elevated total cholesterol, LDL cholesterol, BMI, and waist circumference values, all of which are risk factors of cardiovascular disease. Screening for cardiovascular risk factors should be included in treatment plans for patients with prostate cancer.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
John M Jakicic ◽  
Kelliann K Davis ◽  
Bethany Barone Gibbs ◽  
Diane Helsel ◽  
Wendy C King ◽  
...  

Introduction: Few studies have examined behavioral weight loss interventions with respect to change in cardiovascular disease risk factors in young adults (aged 18 to 35 years). Hypothesis: We tested the hypothesis that a 6 month behavioral weight loss intervention resulted in significant improvements in selective cardiovascular disease risk factors in young adults. Methods: Data are presented as median [25 th , 75 th percentiles]. 470 participants (age: 30.9 [27.8, 33.7] years); BMI: 31.2 [28.4, 34.3] kg/m 2 ) were enrolled in a 6 month behavioral weight loss intervention that included weekly group sessions and prescribed an energy restricted diet and moderate-to-vigorous physical activity. Assessments included weight using a standardized protocol, resting blood pressure, and fasting lipids, glucose, and insulin. Statistical significance of change was according to tests of symmetry or the Wilcoxon matched pairs signed ranks test. Results: The primary outcome (weight) was available for 424 of the 470 participants (90.2%). Weight significantly decreased (-7.8 kg [-12.2, -3.7]) (p<0.0001). Systolic (-4.0 mmHg [-8.5, 0.5] and diastolic blood pressure (-3.0 mmHg [-6.5, 1.0]) decreased (p<0.0001). Total cholesterol (-13 mg/dl [-28.0, 2.0]), LDL cholesterol (-9.5 mg/dl [-21.7, 2.0]), triglycerides (-8.5 mg/dl [-44.0, 9.0]), glucose (-4.0 mg/dl [-8.0, 1.0]), and insulin (-2.6 mIU/L [-5.9, 0.7]) decreased (p<0.0001, n=416). There was not a significant change in HDL cholesterol (p=0.72). Conclusions: In conclusion, after 6 months, weight loss was observed in young adults assigned to this behavioral intervention that focused on physical activity and diet modification. They tended to also have improved cardiovascular disease risk factors. This may demonstrate an approach to reducing cardiovascular disease risk in young adults. Supported by NIH (U01HL096770) and AHA (12BGIA9410032)


Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Sanne A Peters ◽  
Karlijn A Groenewegen ◽  
Hester M den Ruijter ◽  
Michiel L Bots

Background Vascular age is the chronological age of an individual adjusted by their level of atherosclerosis. Vascular age can be used as understandable communication tool towards patients. It has been proposed that carotid intima-media thickness (CIMT) could be used to estimate the vascular age in individuals. The issue on how to best estimate vascular age remains an unanswered question and was evaluated in this study. Methods Data were used from the USE-IMT study collaboration, a global individual patient data meta-analysis including 14 population-based cohorts contributing data for 45 828 individuals. We used two methods to define vascular age. First, vascular age was the age at which a participant’s CIMT value would be at the 50th percentile of the age-and sex specific reference values of the healthy USE-IMT subpopulation (VA50). Second, vascular age was the age at which the estimated cardiovascular risk equals the risk of the observed CIMT value (VArisk). Results Mean (+/- standard deviation [SD]) chronological age, VA50, and VArisk were 58 (9), 63 (19), and 59 (7) years, respectively. VArisk was 0.24 yrs higher in women and 1.5 yrs higher in men than chronological age whereas VA50 was 4.4 yrs higher in women and 5.8 yrs higher in men than chronological age. After adjustment for traditional cardiovascular risk factors, a SD increase in VA50 and VArisk was associated with a 15% (95% confidence interval [CI]: 1.12; 1.19) and 22% (95% CI: 1.17; 1.28) higher risk of cardiovascular disease. For comparison, a SD increase in mean common CIMT increased the risk of cardiovascular disease with 15% (95% CI: 1.12; 1.19). Conclusion We presented two distinct measures a vascular age: VA50, and VArisk. VA50 is a straightforward translation of CIMT and is a measure of the age at which the average person would be expected to have a certain CIMT. In contrast, VArisk incorporates information about expected cardiovascular risk and is the chronological age of a person that conveys the same risk as the CIMT. VA50 and VArisk might provide a convenient transformation of CIMT to a scale that is more easily understood by patients and clinicians.


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