Single-Arm Trial of a Virtual Weight Control Program Tailored for Adults With Type 2 Diabetes on Glycemic Control (VITAL)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Type2 Diabetes
- 发起方
- Pennington Biomedical Research Center
- 入组人数
- 136
- 试验地点
- 3
- 主要终点
- HbA1c
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
The purpose of the study is to evaluate the effect of the WW program on people with Type 2 diabetes and the effect on glycemic control. This study will be a 6 month prospective, single arm clinical trial coordinated by Pennington Biomedical Research Center. Up to 150 participants will be recruited across 3 sites. Participants will have Type 2 diabetes and overweight/obesity.
详细描述
While weight loss (2-5% of total bodyweight) with clinical interventions has been shown to improve glycemic control in patients with Type II Diabetes clinic-based interventions are costly and have poor accessibility for the majority of patients. Commercial weight loss programs like WW (formerly Weight Watchers) are more affordable and accessible than clinic-based modalities, and have been shown to produce effective weight loss in adults with additional improvements in glycemic control. A randomized trial of a modified WW program for patients with Type II Diabetes showed significant reductions in weight and improved glycemic control (HbA1c) compared to standard of care diabetes nutrition counseling and education. Here, we extend prior work by leveraging the efficacy of the WW program for Type II Diabetes, virtually, to increase its reach and its impact on glycemic control. This study aims to test a novel, web-based weight loss intervention from one of the largest and most evidence-based proprietary weight loss programs in the world. Intervention will consist of the WW program modified for people with Type 2 diabetes including weekly Virtual Workshops and use of the WW App. Primary outcomes are any change in HbA1c% over the 6-month intervention. Secondary endpoints are any change in HbA1c% at 3 months, as well as changes at 3 and 6 months in weight, Diabetes Distress Scale, Impact of Weight on Quality of Life, Pittsburgh Sleep Quality Index, hypoglycemic events, WHO-5 Well-being Index, and diabetes medication changes.
研究者
John Apolzan
Assistant Professor - Clinical Nutrition and Metabolism
Pennington Biomedical Research Center
入排标准
入选标准
- •Participant reported diagnosis of Type 2 diabetes
- •HbA1c between 7%-11% (inclusive)
- •BMI 27-50 kg/m2 (inclusive)
- •Age range - 18 - 70 years (inclusive)
- •On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
- •Willingness to attend weekly WW Virtual Workshops and to participate in WW Digital program
- •Access to a iOS smart phone device with internet
- •Willing to follow all requirements of study protocol including blood draws at baseline, week 12, and week
- •Willing and able to provide a valid email address for use in the study
- •Must be able to communicate (oral and written) in English
排除标准
- •Participation in a weight control program within the past 3 months
- •Weight loss of ≥ 5 kg in the previous 6 months
- •Taking prescription or OTC weight loss medications within last 4 weeks
- •History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
- •History of major surgery within three months of enrollment
- •Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
- •Type 1 diabetes
- •Those on insulin or insulin secretagogues
- •Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL
- •Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL)
结局指标
主要结局
HbA1c
时间窗: 6 months
Change in % HbA1c