Dataset Information

Efficacy and safety of an oral device to reduce food intake and promote weight loss.

ABSTRACT: Objective:Minimal risk weight loss tools are needed. This study's objective was to confirm Food and Drug Administration submissions of the SmartByte™ System's safety and efficacy. Methods:This 16-week, prospective, single-arm, four-centre, observational study assessed the oral device in combination with a video-delivered lifestyle programme in adults aged 18-49 years with body mass index 27 to <35 kg m-2. Results:Seventy-six subjects received the device and video lifestyle instruction. The prespecified per protocol (PP) population (N = 40) required sensor-verified use of the device ?7 times per week for 14 of 16 weeks, overall device usage rate of ?33% and study completion. At week 16, 12 (30%) achieved ?5% weight loss, 16 (40%) achieved ?4% and 21 (52.5%) achieved ?3%. Week 16 mean loss for the PP population was 2.93%, and among 36 participants who did not meet PP criteria, it was 1.45%. Among 76 intent-to-treat subjects, two subjects reported three mild to moderate device-related adverse events, resolving spontaneously (one hard palate abrasion and two tongue lacerations). Conclusion:The System, a minimal risk tool, can help individuals achieve meaningful weight loss, when used with a lifestyle video. More frequent device use was associated with more weight loss, on average, and greater chance of achieving ?4% or ?5% weight loss.

SUBMITTER: Ryan DH

PROVIDER: S-EPMC5818751 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Efficacy and safety of an oral device to reduce food intake and promote weight loss.

Ryan D H DH Parkin C G CG Longley W W Dixon J J Apovian C C Bode B B

Obesity science & practice 20171211 1

<h4>Objective</h4>Minimal risk weight loss tools are needed. This study's objective was to confirm Food and Drug Administration submissions of the SmartByte<sup>™</sup> System's safety and efficacy.<h4>Methods</h4>This 16-week, prospective, single-arm, four-centre, observational study assessed the oral device in combination with a video-delivered lifestyle programme in adults aged 18-49 years with body mass index 27 to <35 kg m<sup>-2</sup>.<h4>Results</h4>Seventy-six subjects received the devic ...[more]

PMID: 29479465

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Project description:Background and study aims In the UK, 42,000 people each year are diagnosed with bowel cancer. It is the fourth most common cancer. Surgery to remove the cancer is the best treatment. However, it has a risk of complications, which is doubled for people who are overweight/obese. Patients experiencing complications recover more slowly, stay in the hospital longer and need more care. This isn’t good for patients or the NHS. Physical fitness and well-controlled blood sugar are linked with fewer complications from surgery. For people who are overweight, weight loss improves both of these factors so that it may reduce complications. One reliable way to lose a meaningful amount of weight in the short period before surgery (3-4 weeks) is through a low-calorie diet programme: eating only special nutritious soups and shakes (880 calories/day) that have all the necessary vitamins. With weekly support from a dietitian, most people succeed. Typically, people lose 5% of their weight within 20 days. The NHS uses a version of this programme to treat type 2 diabetes. In small-scale studies, patients with cancer who are overweight have been willing and able to take part in less intensive weight management programmes before surgery but lose little weight. However, the period before bowel cancer surgery is associated with feelings of uncertainty and anxiety, so it is unclear if patients can follow a more intensive programme. Who can participate? To start to find out if this treatment is in the best interests of patients’ physical and mental health, we will recruit 72 overweight patients awaiting bowel cancer surgery What does the study involve? Half of the participants will be randomly allocated to continue with their usual care and half will be offered the weight loss programme. We will see whether enough patients are willing to take part, lose weight, and return for follow-up visits. We will monitor complications for 30 days after surgery and any reduction in muscle mass due to the weight loss. We will interview patients about their experiences. This information will tell us if a full trial is worthwhile to test whether this programme can reduce complications from surgery, improve outcomes for people with bowel cancer, and if the financial costs are likely to be worth the benefits. It will also help us refine the treatment plans according to patient feedback. The researchers discussed the study with seven patients and public representatives (PPI). They thought it was a critical study and the team included their suggestions for making it easier for patients to join the trial, stick to the programme, and attend visits. The research team will work with the PPI throughout the trial.

Project description:Objectives: To investigate the impact of the Cambridge Intensive Weight Management Programme (IWMP) on weight change, eligibility for bariatric surgery, HbA1c, and blood pressure. Design: Prospective non-randomized intervention. Setting: The IWMP is a multi-disciplinary weight loss intervention for severely obese patients to avoid or optimize their physiological state thus enabling bariatric surgery. It uses dietary interventions, pharmacotherapy, and physical activity along with behavior change counseling. Participants: Severely obese patients (Body Mass Index, BMI≥40 kg/m2). Interventions: IWMP is a prospective intervention conducted in a National Health Service Tier 3 obesity service. It includes 3 phases of 8 weeks each: weight loss, weight stabilization, and weight maintenance. In each phase, patients adhered to a prescribed dietary regime and attended regular clinic visits. Data included in this analysis are from those who enrolled in IWMP between 2009 and 2013. Primary and secondary measures: The primary outcome was weight change between baseline and completion of the programme. Secondary outcomes included changes in blood pressure, HbA1c and eligibility for bariatric surgery pre-assessment. Changes in outcomes were compared by age, sex, smoking status, and employment. Results: Of n = 222 eligible patients, complete data were available for n = 141 patients (63.5%). At baseline, the mean (SD) BMI was 49.7 (9.2) kg/m2 for women, and 47.9 (7.2) kg/m2 for men. Mean (SD) weight change for women was -18.64 (8.36) kg and -22.46 (10.98) kg for men. N = 97 (69%) of patients achieved ≥10% weight loss. Individuals aged ≤ 50 years lost significantly more weight than those aged >50 years [mean (SD) weight loss: 22.18 (10.9) kg vs. 18.32 (7.92) kg, p = 0.020]. Changes in weight were non-significant by smoking status or employment. Median (IQR) change in systolic and diastolic blood pressure was -6 (-14.6) mmHg and 0 (-8.6) mmHg (non-significant), respectively. There was ~50% reduction in the need for bariatric surgery. Conclusions: For the majority of the patients, IWMP is promoting weight loss and allowing for avoidance of, or optimization before, bariatric surgery.

Dataset Information

Efficacy and safety of an oral device to reduce food intake and promote weight loss.

Publications

Efficacy and safety of an oral device to reduce food intake and promote weight loss.

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