Take Off Pounds After Stroke Trial (TOPS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Proportion of subjects achieving at least a 5% weight loss
研究概览
简要总结
The Take Off Pounds after Stroke (TOPS) trial is a Prospective Randomized Open-Label Blinded Endpoint (PROBE) study that will test a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, for efficacy in achieving clinically significant weight loss without impairment of physical function patients with elevated body mass index (BMI) following a recent ischemic stroke.
详细描述
The TOPS trial is designed as a PROBE study to test the feasibility, safety, and efficacy of a 12-week high protein, calorie restricted, partial meal replacement program, compared to enhanced standard care, in achieving clinically significant weight loss without impairment of physical function when initiated within 90 days following ischemic stroke in patients with BMI 27-to-49.9 kg/m2.
Participants will be randomized in a 1-1 ratio to the partial meal replacement program (diet intervention) or enhanced standard care (control) with randomization stratified by recruitment center (BIDMC, Yale) and baseline diet consistency status (Modified Consistency Diet vs Regular Consistency Diet). Baseline diet consistency status was selected as a stratification factor because it is expected that patients with difficulty swallowing (dysphagia) after stroke that results in need for modifications to food/liquids will have a different weight loss trajectory than patients who are able to safely consume a regular diet. The follow-up duration will be 12 weeks for all subjects.
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
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor is blinded to study group assignment
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke within 90 days of randomization
- •BMI 27-49.9 mg/kg2
- •Able to meet all nutritional and fluid needs by oral intake.
- •Ready to undergo behavioral change
- •Able and willing to provide written informed consent
- •Maximum weight <=350 lbs
排除标准
- •Medical contraindication to weight loss or diet, including the following: renal disease requiring dialysis, taking lithium, or end stage liver or renal disease considered incompatible with diet intervention by patient's personal healthcare provider or the study PI
- •Enrollment in a conflicting clinical trial (defined as a trial with an intervention known to affect weight or with an exclusion for participation in another trial)
- •Pregnancy or desire to become pregnant, or currently breastfeeding
- •High-risk of malnutrition using a standard screen
- •Trajectory of recent weight loss (i.e., loss of at least 12 lbs in the 3 months preceding screening)
- •Allergy to soy based food products
- •Require thickening of liquids due to dysphagia
- •Inability to communicate with study team
- •Inability to speak English
- •Irreversible medical conditions likely to affect short-term survival (predicted survival of less than one year)
研究组 & 干预措施
Diet Intervention
The diet intervention is a partial meal replacement program using the commercially available OPTAVIA® Optimal Weight 4&2&1 Plan™. In the OPTAVIA program, subjects are asked to eat 6 times each day, once every 2 to 3 hours.
干预措施: Partial meal replacement program (Behavioral)
Enhanced Standard Care
The control group will receive instruction on a healthy diet as defined by the United States Department of Agriculture.
干预措施: Dietary Counseling (Behavioral)
结局指标
主要结局
Proportion of subjects achieving at least a 5% weight loss
时间窗: 12 weeks
Proportion of subjects achieving at least a 5% weight loss from baseline to 12 weeks in the intervention group compared to the control group
次要结局
未报告次要终点
研究者
Jennifer Dearborn-Tomazos
Assistant Professor
Beth Israel Deaconess Medical Center