Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in Weight
研究概览
简要总结
The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.
To achieve these goals, the investigators will pursue the following Specific Aims:
Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.
Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.
Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.
Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participants must be patients of the DOC.
- •BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic backgrounds will be included if have a BMI of ≥25 kg/m
- •Asian patients are allowed to participate at a BMI in the normal range because they are more likely to develop diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).
排除标准
- •Mental illness that would cause disruptions to group meetings
- •Cognitive impairment that would preclude participants from understanding the program
- •Type 2 diabetics on insulin or sulfonylureas without provider approval
- •untreated hyper- or hypothyroidism
- •current cancer diagnosis
- •history of cancer (other than skin cancer)
- •gastrointestinal disorders affecting food intake
- •use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
- •women currently pregnant or lactating, planning to become pregnant, or less than 6 months post-partum
- •weight loss of > 5% in past 6 months
- •major psychiatric disorder
- •current moderate to severe symptoms of depression
- •eating disorders
- •current alcohol or substance abuse.
结局指标
主要结局
Change in Weight
时间窗: Baseline, 12, 24, and 52 weeks
Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.
次要结局
- Retention as measured by attendance sheets(12, 24 and 52 weeks)
- Program Attendance(52 Weeks)