Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic (TOPS at DOC)
Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27701
- Duke General Internal Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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/m2. 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).
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：TOPS
Participants will attend weekly TOPS meetings with standard weekly weigh ins
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Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Weight
大体时间：Baseline, 12, 24, and 52 weeks
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Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks.
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Baseline, 12, 24, and 52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Program Attendance
大体时间：52 Weeks
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Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered).
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52 Weeks
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Retention as measured by attendance sheets
大体时间：12, 24 and 52 weeks
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Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks.
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12, 24 and 52 weeks
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合作者和调查者
调查人员
- 首席研究员：Nia S Mitchell, MD, MPH、Duke University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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