Efficacy of a Food Portion Control Tool to Induce Weight Loss and Decrease Hypoglycemic Medication Requirements Amongst Obese Type 2 Diabetics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- - percentage change in body weight
研究概览
简要总结
The purpose of this study was to determine whether a food portion control tool would be effective to result in weight loss in a group of overweight type 2 diabetics. We hypothesized that this tool would be effective to induce weight loss in these patients. We also hypothesized that diabetic control would be improved in patients using these plates.
详细描述
The prevalence of obesity is increasing worldwide. Portion size is known to be an important determinant of energy intake. However, to our knowledge, no clinical trials have previously been conducted which examine the efficacy of a food portion control tool to control caloric intake and thereby induce weight loss.
Most cases of type 2 diabetes can be attributed directly to obesity. Dietary caloric restriction has been shown to improve glycemic control by virtue of weight loss, with an additional benefit independent of weight loss.
Comparison: daily use of a food portion control tool plus usual care at a diabetes care center, compared to usual care alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •diagnosis of type 2 diabetes mellitus
- •body mass index of 30 or greater
- •a member of the Diabetes Education Center in Calgary, AB, Canada, for at least 6 months prior to study enrollment
排除标准
- •taking a weight loss medication (sibutramine or orlistat)
- •weight loss >10 lbs in 2 months preceding study enrolment
- •consumption of dinner at restaurants more than twice weekly
- •current diagnosis of cancer
- •psychiatric illness under care of a psychiatrist
- •surgery in the 3 months prior to the study, or expected during the study period
- •history of bulimia or anorexia nervosa
结局指标
主要结局
- percentage change in body weight
- proportion of each group that achieve a clinically significant (>=5%) reduction in body weight
- prespecified per protocol analysis: same outcomes as above, looking at patients who were >=80% compliant with the intervention
次要结局
- - change in glycosylated hemoglobin
- - change in serum cholesterol
- - change in blood pressure