NCT04486235

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

Completed NA Results posted Last updated 6 May 2021

What this trial tests

NA trial testing Brief waiting room pamphlet in Obesity in 62 participants. Completed in 1 November 2020.

Timeline

9 April 2019

Primary endpoint
1 September 2020

1 November 2020

Quick facts

Lead sponsor	Drexel University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	62
Start date	9 April 2019
Primary completion	1 September 2020
Estimated completion	1 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Brief waiting room pamphlet

Conditions studied

• Obesity — all drugs for Obesity →
• Primary Care — all drugs for Primary Care →
• Health Communication — all drugs for Health Communication →

Sponsor

Drexel University

Who can join

18 and older, any sex, with Obesity or Primary Care. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Acceptability Questionnaire Primary · 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.

Group	Value	95% CI
Intervention	35.8	± 5.5

Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery Primary · 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%).

Percentage of participants indicated verbal consent for screening

Group	Value	95% CI
Feasibility, Tracked by Participant Flow	60

Percentage of eligible participants after screening

Group	Value	95% CI
Feasibility, Tracked by Participant Flow	53.5

Percentage of screened participants who refuse to participate because of focus on weight

Group	Value	95% CI
Feasibility, Tracked by Participant Flow	0

Percentage of participants who complete the experiential pamphlet

Group	Value	95% CI
Feasibility, Tracked by Participant Flow	86.2

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

Participants respond to Yes/No questions about content of their appointment

Patient-initiated weight discussion occured

Group	Value	95% CI
Intervention	7
Control	5

Patient- or physician-initiated weight discussion occurred

Group	Value	95% CI
Intervention	14
Control	11

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.