Reduction of Cardio-Metabolic Risk and Body Weight through a Multiphasic Very-Low Calorie Ketogenic Diet Program in Women with Overweight/Obesity: A Study in a Real-World Setting

Background: The prevention and treatment of obesity and its cardio-metabolic complications are relevant issues worldwide. Among lifestyle approaches, very low-calorie ketogenic diets (VLCKD) have been shown to lead to rapid initial weight loss, resulting in better long-term weight loss maintenance. As no information on VLCKD studies carried on in a real-world setting are available, we conducted this multi-centre study in a real-world setting, aiming at assessing the efficacy and the safety of a specific multiphasic VLCKD program in women with overweight or obesity. Methods: A multi-center, prospective, uncontrolled trial was conducted in 33 outpatient women (age range 27–60 y) with overweight or obesity (BMI: 30.9 ± 2.7 kg/m2; waist circumference: 96.0 ± 9.4 cm) who started a VLCKD dietary program (duration: 24 weeks), divided into four phases. The efficacy of VLCKD was assessed by evaluating anthropometric measures and cardiometabolic markers; liver and kidney function biomarkers were assessed as safety parameters. Results: The VLCKD program resulted in a significant decrease of body weight and BMI (−14.6%) and waist circumference (−12.4%). At the end of the protocol, 33.3% of the participants reached a normal weight and the subjects in the obesity range were reduced from 70% to 16.7%. HOMA-IR was markedly reduced from 3.17 ± 2.67 to 1.73 ± 1.23 already after phase 2 and was unchanged thereafter. Systolic blood pressure decreased after phase 1 (−3.5 mmHg) and remained unchanged until the end of the program. Total and LDL cholesterol and triglycerides were significantly reduced by VLCKD along with a significant HDL cholesterol increase. Liver, kidney and thyroid function markers did not change and remained within the reference range. Conclusions: The findings of a multi-center VLCKD program conducted in a real-world setting in a cohort of overweight/obese women indicate that it is safe and effective, as it results in a major improvement of cardiometabolic parameters, thus leading to benefits that span well beyond the mere body weight/adiposity reduction.

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A Mediterranean-Based Ketogenic Diet Application Compared to a Calorie-Restricted Low-Fat Diet Application on Cardiometabolic Risk in Adults With Overweight or Obesity

Current Developments in Nutrition ◽

10.1093/cdn/nzab055_021 ◽

2021 ◽

Vol 5 (Supplement_2) ◽

pp. 1211-1211

Author(s):

Kaja Falkenhain ◽

Sean Locke ◽

Dylan Lowe ◽

Nicholas Reitsma ◽

Ethan Weiss ◽

...

Keyword(s):

Weight Loss ◽

Ketogenic Diet ◽

Real World ◽

Health Research ◽

Cardiometabolic Risk ◽

Low Fat Diet ◽

Real World Setting ◽

Breath Acetone ◽

Biofeedback Device ◽

Overweight Or Obesity

Abstract Objectives To determine the effects of a Mediterranean-based ketogenic weight loss diet app paired with a breath acetone biofeedback device compared to a relevant comparator arm on blood biomarkers of cardiometabolic risk in a hands-off, real-world setting. Methods Participants (N = 155) with overweight/obesity (41 ± 11 years, BMI = 32 ± 9 kg/m2, 71% female) were randomized to one of two diet groups, with interventions delivered entirely via mobile app without in-person interaction with study staff: i) a Mediterranean-based ketogenic diet paired with a breath acetone biofeedback device (Keyto); or ii) a calorie-restricted low-fat diet (WW). Participants took daily weight measurements on an at-home wireless scale and a third-party laboratory obtained fasted blood samples at baseline and at 12 weeks. Results Based on intention-to-treat analysis, participants in the Keyto group lost more weight than those in the WW group (−3.1 kg; 95% CI, −4.6 kg to −1.5 kg; P < 0.001). Likewise, those randomized to the Keyto app experienced greater improvements in markers of glycemic control (HbA1c; −0.2%; 95% CI, −0.3% to −0.1%; P < 0.001) and hepatic function (alanine aminotransferase, alkaline phosphatase, globulin; P < 0.01) compared to the WW group. In follow-up analyses accounting for baseline weight and change in body mass, the effects of group assignment on these cardiometabolic risk markers were found to remain significant independent of differences in weight loss between groups. No other differences in blood markers, including lipids and lipoproteins, were found. Conclusions Among adults with overweight or obesity, assignment to the Keyto app, as compared to the WW app, resulted in greater weight loss and cardiometabolic improvements that appeared to be independent of weight loss. These findings suggest that a Mediterranean-based ketogenic diet app paired with a breath acetone biofeedback device is effective at improving cardiometabolic health beyond weight loss in a real-world setting. Funding Sources Canadian Institutes of Health Research (CIHR), Michael Smith Foundation for Health Research (MSFHR), Mitacs Accelerate International with Keyto Inc. as the industry partner.

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Weight Loss Maintenance With Once-Weekly Semaglutide 2.4 MG in Adults With Overweight or Obesity Reaching Maintenance Dose (STEP 4)

Journal of the Endocrine Society ◽

10.1210/jendso/bvab048.129 ◽

2021 ◽

Vol 5 (Supplement_1) ◽

pp. A63-A64

Author(s):

Domenica M Rubino ◽

Niclas Abrahamsson ◽

Melanie Davies ◽

Dan Hesse ◽

Frank L Greenway ◽

...

Keyword(s):

Blood Pressure ◽

Weight Loss ◽

Body Weight ◽

Waist Circumference ◽

Adverse Events ◽

Systolic Blood Pressure ◽

Maintenance Dose ◽

Treatment Policy ◽

The Impact ◽

Overweight Or Obesity

Abstract Background: In people with overweight or obesity, long-term maintenance of weight loss is challenging. Subcutaneous (s.c.) semaglutide, a glucagon-like peptide-1 analogue, has shown clinically-relevant weight loss in a phase 2 trial in people with obesity. STEP 4 investigated the impact of continued semaglutide 2.4 mg treatment, vs switching to placebo, on maintenance of weight loss in participants who reached 2.4 mg of semaglutide during a run-in period. Methods: This was a 68-week withdrawal trial (NCT03548987) in 902 subjects aged ≥18 years with body mass index (BMI) ≥30 kg/m2 (or BMI ≥27 kg/m2 with ≥1 weight-related comorbidity), without diabetes. Following a 20 week run-in period, 803 subjects who reached the maintenance dose of once-weekly (OW) s.c. semaglutide 2.4 mg were randomized 2:1 to continue treatment with semaglutide 2.4 mg or switch to placebo for 48 weeks, both as adjunct to lifestyle intervention. The primary endpoint was percentage change in body weight between randomization (week 20) and week 68. Confirmatory secondary endpoints included change in waist circumference and systolic blood pressure. Two estimands were defined: treatment policy and trial product; results are presented for the treatment policy estimand, unless stated otherwise. Results: Mean body weight (±SD) was 107.2 ±22.7 kg at week 0 and 96.1 ±22.6 kg at randomization (week 20; mean change -10.6%). Randomized participants were mostly female (79%) and white (84%); mean age was 46 years and mean BMI was 34.4 kg/m2. Between weeks 20–68, estimated mean body weight change was −7.9% vs +6.9% for semaglutide 2.4 mg vs placebo (estimated treatment difference [ETD]: −14.8%; 95% confidence interval [CI]: −16.0, −13.5; p<0.0001), and -8.8% vs 6.5%, respectively, for the trial product estimand (ETD: -15.3%; 95% CI: -16.5, -14.1; p<0.0001). For participants randomized to continue semaglutide, the estimated change in body weight from week 0–68 was -17.4% (-18.2% for trial product estimand). Continued semaglutide treatment (weeks 20–68) led to clinically-relevant improvements in waist circumference, systolic blood pressure, BMI, HbA1c, FPG, and lipids (total cholesterol, LDL, VLDL, and triglycerides) vs switching to placebo (p<0.0001 for all). During the run-in period, 5.3% of participants discontinued treatment due to adverse events; during the randomized period, 2.4% (semaglutide) and 2.2% (placebo) discontinued. Nausea, diarrhea and constipation (mostly transient and mild-to-moderate) were the most frequent adverse events with semaglutide. Conclusion: In adults with overweight or obesity, continued treatment after dose escalation with OW s.c. semaglutide 2.4 mg until week 68 led to clinically-relevant weight loss, while switching to placebo led to significant weight regain; these data underscore the chronicity and relapsing nature of obesity, and the need for continued treatment.

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Use of Liraglutide 3.0 mg for Weight Management in a Real-World Setting in Switzerland

Obesity Facts ◽

10.1159/000518325 ◽

2021 ◽

pp. 1-9

Author(s):

Christiane Lundegaard Haase ◽

Maria Giovanna Serratore Achenbach ◽

Gianluca Lucrezi ◽

Nikita Jeswani ◽

Susanne Maurer ◽

...

Keyword(s):

Blood Pressure ◽

Bariatric Surgery ◽

Weight Loss ◽

Body Weight ◽

Real World ◽

Weight Change ◽

Full Cohort ◽

Real World Setting ◽

Diet And Exercise ◽

The Cost

Introduction: Data from randomized controlled trials show that liraglutide 3.0 mg, in combination with diet and exercise, is associated with greater weight loss than diet and exercise alone in patients with obesity. In practice, the utilization of weight loss drugs is influenced by various factors, including the cost of treatment. We conducted a retrospective, observational study to assess the effectiveness of liraglutide 3.0 mg and patients’ persistence on treatment, in a real-world setting. Methods: Data were extracted from de-identified electronic medical records from an obesity management clinic in Switzerland. Changes in body weight and blood pressure were evaluated in the full cohort (N = 277, 19% of whom had undergone bariatric surgery) and subgroups who were persistent on liraglutide 3.0 mg for at least 4 months (n = 236), 7 months (n = 159), or 12 months (n = 71). Results: Median persistence on liraglutide was 6.8 months. Median maximum dose received was 1.5 mg, and 13.7% of patients reached the maintenance dose of 3.0 mg. Mean 7-month weight change from baseline in the full cohort was −4.1 kg (95% confidence interval: −5.0, −3.2; p < 0.001; −4.2%). Weight change was −4.4 kg (−4.7%) in the ≥4-month persistence subgroup at 4 months, −5.1 kg (−5.3%) in the ≥7-month persistence subgroup at 7 months, and −7.5 kg (−7.1%) in the ≥12-month persistence subgroup at 12 months (all p < 0.001). In the full cohort, 40% and 14% of patients lost ≥5% and >10% of body weight at 7 months, respectively. Weight loss did not differ significantly according to history of bariatric surgery (p = 0.94). Diastolic blood pressure decreased (from 87.0 to 83.9 mm Hg at 7 months; p = 0.018), with no significant changes in systolic blood pressure. Approximately two-thirds of patients did not have health insurance that could cover the cost of liraglutide. Conclusion: In a real-world setting with low insurance coverage and with most patients not reaching the recommended maintenance dose of 3.0 mg, the use of liraglutide, in combination with diet and exercise, was associated with clinically meaningful weight loss.

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Liraglutide for Weight Management in the Real World: Significant Weight Loss Even if the Maximal Daily Dose Is Not Achieved

Obesity Facts ◽

10.1159/000520217 ◽

2021 ◽

pp. 1-7

Author(s):

Liesbet Trenson ◽

Sander Trenson ◽

Falco van Nes ◽

Carolien Moyson ◽

Matthias Lannoo ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Weight Management ◽

Real World ◽

Subcutaneous Administration ◽

Maximum Tolerated Dose ◽

Significant Weight Loss ◽

Additional Weight ◽

Obstructive Sleep ◽

Daily Dose

Introduction: Obesity is a global health challenge, and pharmacologic options are emerging. Once daily subcutaneous administration of 3 mg liraglutide, a glucagon like peptide-1 analogue, has been shown to induce weight loss in clinical trials, but real-world effectiveness data are scarce. Methods: It is a single-centre retrospective cohort study of patients who were prescribed liraglutide on top of lifestyle adaptations after multidisciplinary evaluation. In Belgium, liraglutide is only indicated for weight management if the BMI is >30 kg/m2 or ≥27 kg/m2 with comorbidities such as dysglycaemia, dyslipidaemia, hypertension, or obstructive sleep apnoea. No indication is covered by the compulsory health care insurance. Liraglutide was started at 0.6 mg/day and uptitrated weekly until 3 mg/day or the maximum tolerated dose. Treatment status and body weight were evaluated at the 4-month routine visit. Results: Between June 2016 and January 2020, liraglutide was prescribed to 115 patients (77% female), with a median age of 47 (IQR 37.7–54.0) years, a median body weight of 98.4 (IQR 90.0–112.2) kg, a BMI of 34.8 (IQR 32.2–37.4) kg/m2, and an HbA1c level of 5.6%. Five (4%) patients did not actually initiate treatment, 9 (8%) stopped treatment, and 8 (7%) were lost to follow-up. At the 4-month visit, the median body weight had decreased significantly by 9.2% to 90.8 (IQR 82.0–103.5) kg (p < 0.001). Patients using 3.0 mg/day (n = 60) had lost 8.0 (IQR 5.8–10.4) kg. The weight loss was similar (p = 0.9622) in patients that used a lower daily dose because of intolerance: 7.4 (IQR 6.2–9.6) kg for 1.2 mg (n = 3), 7.8 (IQR 4.1–7.8) kg for 1.8 mg (n = 16), and 9.0 (IQR 4.8–10.7) kg for 2.4 mg/day (n = 14). Weight loss was minimal if liraglutide treatment was not started or stopped prematurely (median 3.0 [IQR 0.3–4.8] kg, p < 0.001, vs. on treatment). Further analysis showed an additional weight reduction of 1.8 kg in the patients that had started metformin <3 months before the start of liraglutide (p < 0.001). The main reasons for liraglutide discontinuation were gastrointestinal complaints (n = 5/9) and drug cost (n = 2/9). Conclusion: In this selected group of patients, the majority complied with liraglutide treatment over the initial 4-month period and achieved a significant weight loss, irrespective of the maximally tolerated maintenance dose. Addition of metformin induced a small but significant additional weight loss.

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Protocol for a randomised controlled trial of the combined effects of the GLP-1 receptor agonist liraglutide and exercise on maintenance of weight loss and health after a very low-calorie diet

BMJ Open ◽

10.1136/bmjopen-2019-031431 ◽

2019 ◽

Vol 9 (11) ◽

pp. e031431

Author(s):

Simon Birk Kjær Jensen ◽

Julie Rehné Lundgren ◽

Charlotte Janus ◽

Christian Rimer Juhl ◽

Lisa Møller Olsen ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Receptor Agonist ◽

Controlled Trial ◽

Good Clinical Practice ◽

Study Groups ◽

Very Low Calorie Diet ◽

Low Calorie ◽

Low Calorie Diet ◽

Calorie Diet

IntroductionThe success rate of weight loss maintenance is limited. Therefore, the purpose of this study is to investigate the maintenance of weight loss and immunometabolic health outcomes after diet-induced weight loss followed by 1-year treatment with a glucagon-like peptide-1 receptor agonist (liraglutide), physical exercise or the combination of both treatments as compared with placebo in individuals with obesity.Methods and analysisThis is an investigator-initiated, randomised, placebo-controlled, parallel group trial. We will enrol expectedly 200 women and men (age 18–65 years) with obesity (body mass index 32–43 kg/m2) to adhere to a very low-calorie diet (800 kcal/day) for 8 weeks in order to lose at least 5% of body weight. Subsequently, participants will be randomised in a 1:1:1:1 ratio to one of four study groups for 52 weeks: (1) placebo, (2) exercise 150 min/week+placebo, (3) liraglutide 3.0 mg/day and (4) exercise 150 min/week+liraglutide 3.0 mg/day. The primary endpoint is change in body weight from randomisation to end-of-treatment.Ethics and disseminationThe trial has been approved by the ethical committee of the Capital Region of Denmark and the Danish Medicines Agency. The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.Trial registration number2015-005585-32

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THE BENEFIT OF SHORT-TERM WEIGHT LOSS WITH ANTI-OBESITY MEDICATIONS IN REAL-WORLD CLINICAL PRACTICE

Endocrine Practice ◽

10.4158/ep-2019-0081 ◽

2019 ◽

Vol 25 (10) ◽

pp. 1022-1028

Author(s):

Kelly Shibuya ◽

Khawla F. Ali ◽

Xinge Ji ◽

Alex Milinoivh ◽

Janine Bauman ◽

...

Keyword(s):

Body Mass Index ◽

Weight Loss ◽

Body Weight ◽

Body Mass ◽

Real World ◽

Significant Weight Loss ◽

Short Term ◽

Absolute Weight ◽

Tertiary Healthcare

Objective: The effectiveness of anti-obesity medications (AOMs) outside of clinical trials is unclear. The objective of this study was to compare the short-term effectiveness of AOMs in real-world practice. Methods: This retrospective study included adults aged ≥18 years, with body mass index ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity who were prescribed phentermine hydrochloride, phenterminetopiramate, bupropion-naltrexone, or lorcaserin for 12 consecutive weeks between 2006 and 2016 at a large tertiary healthcare system. Propensity score–matched cohorts were created for each pair of AOMs. The primary outcomes were percent and absolute weight loss from baseline after 12 weeks. A prediction model was constructed to estimate weight loss with different AOMs based on demographic and clinical data. Results: Of the 3,411 patients included in this study, patients lost an average of 3.45% of body weight from baseline. All AOMs were associated with a significant weight loss from baseline ( P<.0001). Patients lost the highest percentage of body weight on phentermine hydrochloride (3.75 ± 5.66%), followed by phentermine-topiramate (3.63 ± 5.7%), bupropion-naltrexone (2.66 ± 5.03%), and lorcaserin (1.84 ± 6.69%). In propensity-matched cohorts, patients taking phentermine hydrochloride lost more weight than those taking lorcaserin or bupropion-naltrexone, and patients taking phentermine topiramate lost more weight than patients taking lorcaserin. Conclusion: In real-world practice, AOMs are associated with clinically meaningful weight loss of 2 to 4% after 12 weeks. In this study, phentermine hydrochloride and phentermine topiramate produced the most weight loss. AOMs should be seriously considered as part of the armamentarium to treat patients with obesity. Abbreviations: AOM = anti-obesity medication; BMI = body mass index; EMR = electronic medical record; FDA = Food and Drug Administration; T2D = type 2 diabetes

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An open study of the effectiveness of a multi-component weight-loss intervention for adults with intellectual disabilities and obesity

British Journal Of Nutrition ◽

10.1017/s0007114510005362 ◽

2011 ◽

Vol 105 (10) ◽

pp. 1553-1562 ◽

Cited By ~ 50

Author(s):

Craig A. Melville ◽

Susan Boyle ◽

Susan Miller ◽

Susan Macmillan ◽

Victoria Penpraze ◽

...

Keyword(s):

Weight Loss ◽

Body Weight ◽

Waist Circumference ◽

Intellectual Disabilities ◽

Sedentary Behaviour ◽

Energy Deficit ◽

Controlled Study ◽

Weight Loss Intervention ◽

Before And After ◽

Adults With Intellectual Disabilities

Adults with intellectual disabilities experience high rates of obesity. Despite this higher risk, there is little evidence on the effectiveness of weight-loss interventions for adults with intellectual disabilities and obesity. The present study examined the effectiveness of the TAKE 5 multi-component weight-loss intervention. Adults with obesity were invited using specialist intellectual disability services to participate in the study. Obesity was defined as a BMI of 30 kg/m2 or greater. TAKE 5 included a daily energy-deficit diet of 2510 kJ (600 kcal), achieved via a personalised dietary prescription. Participants' body weight, BMI, waist circumference and levels of physical activity and sedentary behaviour were measured before and after the intervention. A total of fifty-four individuals consented to participate, of which forty-seven (87 %) completed the intervention in the study period. There was a significant decrease in body weight (mean difference − 4·47 (95 % CI − 5·91, − 3·03) kg; P < 0·0001), BMI ( − 1·82 (95 % CI − 2·36, − 1·29) kg/m2; P < 0·0001), waist circumference ( − 6·29 (95 % CI − 7·85, − 4·73) cm; P < 0·0001) and daily sedentary behaviour of participants ( − 41·40 (95 % CI − 62·45, − 20·35) min; P = 0·00 034). Of the participants who completed the intervention, seventeen (36·2 %) lost 5 % or more of their initial body weight. Findings from the study suggest that TAKE 5 is an effective weight-loss intervention for adults with intellectual disabilities and obesity. The effectiveness of TAKE 5 should be examined further in a controlled study.

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Contemporary management and associated outcomes of 3,151 patients with stage III non-small cell lung cancer (NSCLC) in a real-world setting: Results of KINDLE, a multicountry observational study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.9043 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 9043-9043

Author(s):

Abdul Rahman Jazieh ◽

Huseyin Cem Onal ◽

Daniel Shao-Weng Tan ◽

Ross A. Soo ◽

Kumar Prabhash ◽

...

Keyword(s):

Observational Study ◽

Real World ◽

Stage Iii ◽

Smoking History ◽

Treatment Modalities ◽

Multi Centre Study ◽

Disease Characteristics ◽

Real World Setting ◽

Geographical Regions ◽

Stage Iii Nsclc

9043 Background: Stage III NSCLC is a heterogeneous disease requiring a multimodality approach. We conducted a global study to characterise the patients (pts), treatment patterns and their associated outcomes for this disease in a real-world setting in the pre-IO era. Methods: KINDLE is a retrospective, multi-country, multi-centre study capturing data on patient and disease characteristics, treatments and outcomes. The study included pts with stage III NSCLC diagnosed between January 1st, 2013 and December 31st, 2017 and with at least 9 months of documented follow-up. Descriptive statistics were used to describe patient demographics, disease characteristics and treatment modalities. Inferential statistics was used to correlate various clinical and treatment variables with progression free survival (PFS) and overall survival (OS). Results: 3151 patients were enrolled at 125 centres in three geographical regions; 1046 pts in Middle East and North Africa, 1874 pts in Asia and 231 pts in Latin America. Median age was 63 years (range 21-92); 76.5% were male; 69.2% with a smoking history; 55.9% were staged as IIIA (AJCC 7th ed.); 53.7% had adenocarcinoma and 36.6% squamous cell, and 31.7% were known to have an EGFR mutation. 21.4% of patients underwent curative surgical resection. First line therapy included more than 25 different regimens, the most common being concurrent chemo-radiotherapy (cCRT) in 29.4%, chemotherapy (CT) alone in 17%, sequential chemo-radiotherapy (sCRT) in 10.4%, and radiotherapy (RT) alone in 8.5%. Median PFS for the whole cohort was 12.5 mos (95% CI; 12.06 – 13.14) and median OS 34.9 mos (95% CI; 32.00 – 38.01). Stage IIIA patients who were eligible for and underwent surgery + CT, had longer OS than patients who did not undergo surgery, receiving other treatments. Non-surgical approaches included CT, RT, and CRT. In stage IIIB, OS was significantly improved for cCRT vs. CT alone (p = 0.0015) or RT alone (p = < 0.0001) or sCRT (p = 0.0216). Improved survival was observed with sCRT compared with RT alone and chemotherapy vs RT alone. Conclusions: KINDLE, a large multi-country observational study, reveals the diversity of treatment practices that exist in stage III NSCLC and provides insights on the outcomes in a real-world setting. The unmet medical need remains high and approaches are required to optimize patient outcomes including implementation of guidelines, physician education and improved access to innovative medicines and quality care.

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A Meta-Analysis of Intervention Trials Examining the Effects of A Simple 2-Week Weight Loss Program on Body Weight and Waist Circumference

Journal of Nutritional Health & Food Science ◽

10.15226/jnhfs.2016.00154 ◽

2016 ◽

Vol 4 (1) ◽

pp. 01-09

Author(s):

Vanessa Perez

Keyword(s):

Weight Loss ◽

Body Weight ◽

Waist Circumference ◽

Meta Analysis ◽

Weight Loss Program ◽

Intervention Trials

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Effectiveness of the Low Carb Program digital intervention to instigate and sustain self-management of type 2 diabetes and prediabetes in an NHS England GP practice: service evaluation of real-world data (Preprint)

10.2196/preprints.25751 ◽

2020 ◽

Author(s):

Charlotte Summers ◽

Simon Tobin ◽

David Unwin

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Primary Care ◽

Weight Loss ◽

Type 2 Diabetes Mellitus ◽

Body Weight ◽

Glycemic Control ◽

Real World ◽

Self Management

BACKGROUND Type 2 diabetes mellitus has serious health consequences, including blindness, amputation, and stroke. There is increasing evidence that type 2 diabetes may be effectively treated with a carbohydrate-reduced diet. Digital apps are increasingly used as an adjunct to traditional health care provisions to support behaviour change and remote self-management of long-term health conditions. OBJECTIVE Our objective was to evaluate the real-world 12-month outcomes of patients prescribed the Low Carb Program (LCP) digital health at a primary care NHS site, Norwood Surgery in Southport, United Kingdom. The Low Carb Program is a nutritionally focused, digitally delivered behaviour change intervention for glycemic control and weight loss for adults with prediabetes and type 2 diabetes. METHODS We evaluated the real-world, self-reported outcomes of patients referred to the Low Carb Program by doctors at an NHS GP surgery in Southport, United Kingdom. All of the NHS patients referred to the program were diagnosed with Type 2 diabetes mellitus (T2DM) or prediabetes and given the program at no cost (N=45; mean age 54.8, SD 13.2 years; 42% (19/45) women; mean glycated hemoglobin A1c (HbA1c) 56.7 mmol/mol (range 42.1mmol/mol - 96.7mmol/mol); mean body weight 89.4 kg (SD 13.8 kg). RESULTS Of the 100 people offered the program 45 participants enrolled, all of them (100%) activated their accounts and 37 (82.2%) individuals self-reported outcomes at 12-months. Of those who enrolled 45 (100%) patients completed at least 40% of the lessons, 32 (71.1%) individuals completed >9 out of 12 core lessons of the program. Glycemic control and weight loss improved, particularly for participants who completed >9 of the 12 core lessons in the program over 12-months; mean HbA1c went from 58.8 mmol/mol at baseline to 54.0 mmol/mol (4.78 mmol/mol, SD 4.60), t(31)=5.87, p<0.001) and reported an average 4.17% total body weight reduction with an average reduction of 3.85kg (SD 2.35), t(31)=9.27, p<0.001) at the 12-month follow up point. CONCLUSIONS Though the data presented here has several limitations, the use of a digital app prescribed to adults with T2DM or prediabetes in a primary care setting supporting a transition to a low carbohydrate diet appears to show significant improvements in glycaemic control and weight loss. Further research to understand more about factors affecting engagement and further positive health implications would be valuable.

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