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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486235
• Other study ID #: 1812006829
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: April 2020
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Communication
• Obesity
• Primary Care
• Weight Gain

Intervention

Behavioral:
• Brief waiting room pamphlet
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.

Locations

Country	Name	City	State
United States	Drexel University Family Medicine Office	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after appointment (Same day as intervention delivery)
Primary	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%).	When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months
Secondary	If Weight Was Spoken About in the Appointment	Participants respond to Yes/No questions about content of their appointment	Immediately after appointment (Same day as intervention delivery)