跳至主要内容
临床试验/NCT04486235
NCT04486235已完成不适用

A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care

Drexel University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年4月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery

研究概览

简要总结

This study tests the feasibility, acceptability, and preliminary efficacy of using a brief pamphlet in the primary care waiting room focused on promoting patient-initiated weight-related discussions in primary care appointments.

详细描述

Obesity is a chronic and complex disease that many national and professional organizations recommend be discussed frequently in primary care. However, rates of weight-related communication in primary care are suboptimal. When patients and physicians communicate about weight (defined as usage of any the 5As-ask, assess, advise, agree, and/or assist-in a weight-related conversation), patients are more likely to improve dietary habits, demonstrate more motivation for health behavior change, attempt weight loss treatment, and lose more weight as compared to patients who do not engage in weight-related communication with their physicians. Interventions have attempted to increase the rates of weight-related communication in primary care. However, they have focused solely on physicians and have only yielded modest efficacy. Intervention with patients on proposed patient-related barriers may be key to improving the rate of weight-related communication in primary care. The waiting room prior to appointments is an underutilized intervention setting. Prior waiting room interventions have shown promising results for increasing health communication between patients and physicians. However, no prior study has focused on weight-related communication. Thus, this study aims to test the feasibility, acceptability, and preliminary efficacy of an experiential pamphlet delivered in the waiting room targeting patient-related barriers to weight communication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

The condition of the participant is revealed after the participant completes the consent form and screening questionnaire and is deemed eligible.

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

  • •Present for an appointment at the Family Medicine Office
  • •Indicate that they can speak and read English
  • •Indicate that their Shape is > or = 5 on measure (Stunkard, Sørensen, & Schulsinger, 1983)
  • •Indicate that they are 18 years or older

排除标准

  • •Indicate that they are Pregnant

研究组 & 干预措施

Intervention

Experimental

Receive experiential pamphlet

干预措施: Brief waiting room pamphlet (Behavioral)

Control

No Intervention

No materials, usual care

结局指标

主要结局

Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery

时间窗: When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months

Study flow will be tracked by study staff and compared to pre-determined benchmarks. 1) Percentage of patients who indicate verbal consent for screening (benchmark \>70%), 2) percentage of eligible participants after screening (benchmark \>50%), 3) percentage of participants who refuse to participate because of focus on weight (benchmark \<20%), 4)percentage of participants who complete the experiential pamphlet (benchmark \>80%).

Treatment Acceptability Questionnaire

时间窗: Immediately after appointment (Same day as intervention delivery)

Intervention participants reported acceptability, as measured by the Treatment Acceptability Questionnaire (Hunsley, 1992). This is a 6-item scale that asks the participant to rate several metrics of acceptability with Likert scale responses (individual items range 1-7, one item is reverse scored). A higher score indicates greater acceptability, a score of 21 is the benchmark for acceptability. Overall range of 6-42.

次要结局

  • If Weight Was Spoken About in the Appointment(Immediately after appointment (Same day as intervention delivery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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