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

NCT04486235 | Completed Results

• 1 other identifier: 1812006829
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Primary Care; Health Communication

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• If Weight Was Spoken About in the Appointment

  Immediately after appointment (Same day as intervention delivery)

Study Arms (2)

Intervention

EXPERIMENTAL

Receive experiential pamphlet

Behavioral: Brief waiting room pamphlet

Control

NO INTERVENTION

No materials, usual care

Interventions

Brief waiting room pamphlet BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Indicate that they are Pregnant

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University Family Medicine Office

Philadelphia, Pennsylvania, 19127, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size, location for study was primarily staffed by Family Medicine residents which may limit generalizability

Results Point of Contact

• Title: Jocelyn Remmert, PhD
• Organization: Corporal Michael J. Crescenz VA Medical Center

jocelyn.remmert@va.gov

215-823-5800

Study Officials

• Jocelyn Remmert, MS

  Drexel University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The condition of the participant is revealed after the participant completes the consent form and screening questionnaire and is deemed eligible.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: July 24, 2020
• Study Start: April 9, 2019
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2020-04

Locations

US (1)