Trial Outcomes & Findings for A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care (NCT NCT04486235)
NCT ID: NCT04486235
Last Updated: 2021-05-06
Results Overview
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.
COMPLETED
NA
62 participants
Immediately after appointment (Same day as intervention delivery)
2021-05-06
Participant Flow
Participant milestones
| Measure |
Intervention
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.
|
Control
No materials, usual care
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
Analysis
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Intervention
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.
|
Control
No materials, usual care
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Randomized, Controlled Pilot Study of a Patient-Initiated Approach to Increasing Weight Communication in Primary Care
Baseline characteristics by cohort
| Measure |
Intervention
n=30 Participants
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.
|
Control
n=30 Participants
No materials, usual care
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.1 years
STANDARD_DEVIATION 15.4 • n=99 Participants
|
38.2 years
STANDARD_DEVIATION 16.02 • n=107 Participants
|
40.6 years
STANDARD_DEVIATION 15.8 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Transgender
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately after appointment (Same day as intervention delivery)Population: Only intervention participants saw the pamphlet and provided acceptability feedback
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.
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
|
Control
No materials, usual care
|
|---|---|---|
|
Treatment Acceptability Questionnaire
|
35.8 units on a scale
Standard Deviation 5.5
|
—
|
PRIMARY outcome
Timeframe: When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 monthsPopulation: Tracked by participant flow, 295 participants invited to participate by research staff, eventually resulting 135 assessed for eligibility, and ultimately 62 randomized
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%).
Outcome measures
| Measure |
Intervention
n=295 Participants
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.
|
Control
No materials, usual care
|
|---|---|---|
|
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
Percentage of participants indicated verbal consent for screening
|
60 percentage of participants
|
—
|
|
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
Percentage of eligible participants after screening
|
53.5 percentage of participants
|
—
|
|
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
Percentage of screened participants who refuse to participate because of focus on weight
|
0 percentage of participants
|
—
|
|
Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery
Percentage of participants who complete the experiential pamphlet
|
86.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Immediately after appointment (Same day as intervention delivery)Participants respond to Yes/No questions about content of their appointment
Outcome measures
| Measure |
Intervention
n=30 Participants
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.
|
Control
n=30 Participants
No materials, usual care
|
|---|---|---|
|
If Weight Was Spoken About in the Appointment
Patient-initiated weight discussion occured
|
7 Participants
|
5 Participants
|
|
If Weight Was Spoken About in the Appointment
Patient- or physician-initiated weight discussion occurred
|
14 Participants
|
11 Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jocelyn Remmert, PhD
Corporal Michael J. Crescenz VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place