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

Sponsor
Drexel University (Other)
Overall Status
Completed
CT.gov ID
NCT04486235
Collaborator
(none)
62
1
2
18.8
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief waiting room pamphlet
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Primary Purpose:
Other
Official Title:
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Actual Study Start Date :
Apr 9, 2019
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Receive experiential pamphlet

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.

No Intervention: Control

No materials, usual care

Outcome Measures

Primary Outcome Measures

  1. Treatment Acceptability Questionnaire [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.

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

Secondary Outcome Measures

  1. If Weight Was Spoken About in the Appointment [Immediately after appointment (Same day as intervention delivery)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

  • Indicate that they are 18 years or older
Exclusion Criteria:
  • Indicate that they are Pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Drexel University Family Medicine Office Philadelphia Pennsylvania United States 19127

Sponsors and Collaborators

  • Drexel University

Investigators

  • Principal Investigator: Jocelyn Remmert, MS, Drexel University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Drexel University
ClinicalTrials.gov Identifier:
NCT04486235
Other Study ID Numbers:
  • 1812006829
First Posted:
Jul 24, 2020
Last Update Posted:
May 6, 2021
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Intervention Control
Arm/Group Description Receive experiential pamphlet 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. No materials, usual care
Period Title: Overall Study
STARTED 32 30
Analysis 30 30
COMPLETED 30 30
NOT COMPLETED 2 0

Baseline Characteristics

Arm/Group Title Intervention Control Total
Arm/Group Description Receive experiential pamphlet 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. No materials, usual care Total of all reporting groups
Overall Participants 30 30 60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
43.1
(15.4)
38.2
(16.02)
40.6
(15.8)
Sex/Gender, Customized (Count of Participants)
Male
17
56.7%
14
46.7%
31
51.7%
Female
13
43.3%
15
50%
28
46.7%
Transgender
0
0%
1
3.3%
1
1.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
3.3%
0
0%
1
1.7%
Not Hispanic or Latino
29
96.7%
29
96.7%
58
96.7%
Unknown or Not Reported
0
0%
1
3.3%
1
1.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
2
6.7%
2
3.3%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
11
36.7%
10
33.3%
21
35%
White
16
53.3%
15
50%
31
51.7%
More than one race
3
10%
3
10%
6
10%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
30
100%
30
100%
60
100%

Outcome Measures

1. Primary Outcome
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)

Outcome Measure Data

Analysis Population Description
Only intervention participants saw the pamphlet and provided acceptability feedback
Arm/Group Title Intervention Control
Arm/Group Description Receive experiential pamphlet 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. No materials, usual care
Measure Participants 30 0
Mean (Standard Deviation) [units on a scale]
35.8
(5.5)
2. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
Tracked by participant flow, 295 participants invited to participate by research staff, eventually resulting 135 assessed for eligibility, and ultimately 62 randomized
Arm/Group Title Feasibility, Tracked by Participant Flow
Arm/Group Description Feasibility was measured by tracking flow and calculating: 1) Percentage of patients who indicate verbal consent for screening, 2) percentage of eligible participants after screening, 2) percentage of participants who refuse to participate because of focus on weight, 3)percentage of participants who complete the experiential pamphlet. Study flow will be tracked by study staff and compared to pre-determined benchmarks
Measure Participants 295
Percentage of participants indicated verbal consent for screening
60
200%
Percentage of eligible participants after screening
53.5
178.3%
Percentage of screened participants who refuse to participate because of focus on weight
0
0%
Percentage of participants who complete the experiential pamphlet
86.2
287.3%
3. Secondary Outcome
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)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Arm/Group Description Receive experiential pamphlet 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. No materials, usual care
Measure Participants 30 30
Patient-initiated weight discussion occured
7
23.3%
5
16.7%
Patient- or physician-initiated weight discussion occurred
14
46.7%
11
36.7%

Adverse Events

Time Frame Collected data from participants during primary care appointment (approx. 15-90 min), data collection occurred over a period of 6 months
Adverse Event Reporting Description This was a brief, low risk study of providing a pamphlet about health and weight to patients in the waiting room before a primary care appointment
Arm/Group Title Intervention Control
Arm/Group Description Receive experiential pamphlet 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. No materials, usual care
All Cause Mortality
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/32 (0%) 0/30 (0%)
Serious Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/32 (0%) 0/30 (0%)
Other (Not Including Serious) Adverse Events
Intervention Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/32 (0%) 0/30 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Jocelyn Remmert, PhD
Organization Corporal Michael J. Crescenz VA Medical Center
Phone 215-823-5800
Email jocelyn.remmert@va.gov
Responsible Party:
Drexel University
ClinicalTrials.gov Identifier:
NCT04486235
Other Study ID Numbers:
  • 1812006829
First Posted:
Jul 24, 2020
Last Update Posted:
May 6, 2021
Last Verified:
Apr 1, 2020