A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Primary Purpose
Obesity, Primary Care, Health Communication
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief waiting room pamphlet
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Indicate that they are Pregnant
Sites / Locations
- Drexel University Family Medicine Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Receive experiential pamphlet
No materials, usual care
Outcomes
Primary Outcome Measures
Treatment Acceptability Questionnaire
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.
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
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%).
Secondary Outcome Measures
If Weight Was Spoken About in the Appointment
Participants respond to Yes/No questions about content of their appointment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486235
Brief Title
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Official Title
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Primary Care, Health Communication
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization is stratified. On the screening form, participants indicate whether or not they plan to speak with their physician about their weight in their appointment. Randomization is stratified by if if the participant indicates that they plan to speak about weight or not.
Masking
None (Open Label)
Masking Description
The condition of the participant is revealed after the participant completes the consent form and screening questionnaire and is deemed eligible.
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receive experiential pamphlet
Arm Title
Control
Arm Type
No Intervention
Arm Description
No materials, usual care
Intervention Type
Behavioral
Intervention Name(s)
Brief waiting room pamphlet
Intervention Description
An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.
Primary Outcome Measure Information:
Title
Treatment Acceptability Questionnaire
Description
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.
Time Frame
Immediately after appointment (Same day as intervention delivery)
Title
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
Description
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%).
Time Frame
When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months
Secondary Outcome Measure Information:
Title
If Weight Was Spoken About in the Appointment
Description
Participants respond to Yes/No questions about content of their appointment
Time Frame
Immediately after appointment (Same day as intervention delivery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- Indicate that they are Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Remmert, MS
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University Family Medicine Office
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19127
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
We'll reach out to this number within 24 hrs