Clinical trial NCT04486235: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Primary Care
Health Communication
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Treatment Acceptability Questionnaire
timeFrame: Immediately after appointment (Same day as intervention delivery)
measure: Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
timeFrame: When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months
Secondary outcomes:
measure: If Weight Was Spoken About in the Appointment
timeFrame: Immediately after appointment (Same day as intervention delivery)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University Family Medicine Office
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Jocelyn Remmert, MS
role: PRINCIPAL_INVESTIGATOR
References: