Health Communication, Obesity, Primary Care
Conditions
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.
Interventions
BEHAVIORALBrief 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.
Sponsors
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
The condition of the participant is revealed after the participant completes the consent form and screening questionnaire and is deemed eligible.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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, 1983) * Indicate that they are 18 years or older
Exclusion criteria
\- Indicate that they are Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Control No materials, usual care | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 15.4 | 40.6 years STANDARD_DEVIATION 15.8 | 38.2 years STANDARD_DEVIATION 16.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 31 Participants | 15 Participants |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex/Gender, Customized Female | 13 Participants | 28 Participants | 15 Participants |
| Sex/Gender, Customized Male | 17 Participants | 31 Participants | 14 Participants |
| Sex/Gender, Customized Transgender | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 0 / 32 | 0 / 30 |
| serious Total, serious adverse events | 0 / 32 | 0 / 30 |
Outcome results
Primary
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%).
Time frame: When study staff is recruiting in the office during the data collection period, approx. 20 days over 6 months
Population: Tracked by participant flow, 295 participants invited to participate by research staff, eventually resulting 135 assessed for eligibility, and ultimately 62 randomized
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention | Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery | Percentage of eligible participants after screening | 53.5 percentage of participants |
| Intervention | Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery | Percentage of participants indicated verbal consent for screening | 60 percentage of participants |
| Intervention | 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 |
| Intervention | Feasibility of Recruitment From Primary Care Waiting Room and Intervention Delivery | Percentage of participants who complete the experiential pamphlet | 86.2 percentage of participants |
Primary
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.
Time frame: Immediately after appointment (Same day as intervention delivery)
Population: Only intervention participants saw the pamphlet and provided acceptability feedback
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Treatment Acceptability Questionnaire | 35.8 units on a scale | Standard Deviation 5.5 |
Secondary
If Weight Was Spoken About in the Appointment
Participants respond to Yes/No questions about content of their appointment
Time frame: Immediately after appointment (Same day as intervention delivery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | If Weight Was Spoken About in the Appointment | Patient-initiated weight discussion occured | 7 Participants |
| Intervention | If Weight Was Spoken About in the Appointment | Patient- or physician-initiated weight discussion occurred | 14 Participants |
| Control | If Weight Was Spoken About in the Appointment | Patient-initiated weight discussion occured | 5 Participants |
| Control | If Weight Was Spoken About in the Appointment | Patient- or physician-initiated weight discussion occurred | 11 Participants |