Obesity
Conditions
Brief summary
This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.
Detailed description
This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.
Interventions
BEHAVIORALMotivational Intervention
Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
Participants informed that they have access to weight loss treatment.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Staff recruiting participants and doing outcomes assessment will remain blinded to treatment assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Primary care provider Inclusion criteria: * Employed by Duke PCRC clinic as primary care provider at least ½ FTE. * Has a primary adult panel * Has worked at Duke PCRC clinic for at least one year Patient inclusion criteria * BMI ≥ 30 kg/m2 as measured at any clinic in previous 12 months. * English speaking * Self-report BMI ≥ 29 kg/m2 (to allow for under-reporting) * Regular email usage, defined as accessing email 3 or more times per week (on home or work computer or cell phone) * Age 18-75 * Clinical appointment (well visit or chronic care visit) with enrolled Duke provider in 2-6 weeks of record review. * At least one prior appointment with the provider they are scheduled to see at target clinical appt. * Has a valid email address in electronic health records. Patient
Exclusion criteria
* In weight loss treatment program in past year * Unable to read content on websites without any assistance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Attending 6 Month Follow-up Appointment | 6 months | Count of enrolled participants who attend 6 month follow-up appointment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability (Acceptability Outcome) | 1 month | Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | 6 months | Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one) |
Countries
United States
Participant flow
Recruitment details
All six providers who were recruited through a Duke Health primary care-based research network and were present at a primary care clinic provider meeting in February 2017, were eligible and consented to participate. Patients of the enrolled providers were recruited from May 2017 to August 2017 through an electronic health record database search.
Pre-assignment details
None of the providers were withdrawn from the study. Of the 66 patients initially consented, 6 withdrew prior to learning their randomization assignment; 4 chose to withdraw for no stated reason; one was withdrawn by the study team due to being in treatment; and one was withdrawn by the study team due to canceling their index appointment.
Participants by arm
| Arm | Count |
|---|---|
| Mobilization Tool Arm Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Motivational Intervention: Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment. | 34 |
| Comparator Tool Arm Participant receives access to weight loss treatment alone.
Comparator Intervention: Participants informed that they have access to weight loss treatment. | 26 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 4 |
| Overall Study | Withdrawn by Study Team | 1 | 1 |
Baseline characteristics
| Characteristic | Comparator Tool Arm | Total | Mobilization Tool Arm |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 10.9 | 54.6 years STANDARD_DEVIATION 12.7 | 54.4 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized African American | 9 Participants | 19 Participants | 10 Participants |
| Race/Ethnicity, Customized Other or multiple races | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 16 Participants | 39 Participants | 23 Participants |
| Sex: Female, Male Female | 15 Participants | 34 Participants | 19 Participants |
| Sex: Female, Male Male | 11 Participants | 26 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 26 |
| other Total, other adverse events | 0 / 34 | 0 / 26 |
| serious Total, serious adverse events | 1 / 34 | 0 / 26 |
Outcome results
Primary
Number of Participants Attending 6 Month Follow-up Appointment
Count of enrolled participants who attend 6 month follow-up appointment
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mobilization Tool Arm | Number of Participants Attending 6 Month Follow-up Appointment | 22 Participants |
| Comparator Tool Arm | Number of Participants Attending 6 Month Follow-up Appointment | 19 Participants |
Secondary
Intervention Acceptability (Acceptability Outcome)
Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11.
Time frame: 1 month
Population: Among mobilization tool participants, 28 patients progressed past the tool's introductory page, and 27 patients completed the tool. The post-tool acceptability survey was completed by 20 participants (72% of those who began the tool).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 1: Enjoyed | 4.15 score on a item | Standard Deviation 0.67 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 2: Learning | 4.05 score on a item | Standard Deviation 0.83 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 3: Easy to use | 4.25 score on a item | Standard Deviation 0.72 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 4: Secure | 4.30 score on a item | Standard Deviation 0.73 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 5: Interested | 4.10 score on a item | Standard Deviation 0.72 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 6: Trustworthy | 4.15 score on a item | Standard Deviation 0.75 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 7: Enough time | 4.15 score on a item | Standard Deviation 0.75 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 8: Easy to understand | 4.35 score on a item | Standard Deviation 0.59 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 9: Easy to navigate | 4.40 score on a item | Standard Deviation 0.5 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 10: Useful | 4.15 score on a item | Standard Deviation 0.67 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 11: Too long | 2.45 score on a item | Standard Deviation 1.39 |
| Mobilization Tool Arm | Intervention Acceptability (Acceptability Outcome) | Item 12: Enough information | 4.10 score on a item | Standard Deviation 0.64 |
Other Pre-specified
Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report
Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one)
Time frame: 6 months
Population: Six participants withdrew prior to learning randomization condition and were not followed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mobilization Tool Arm | Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | Treatment initiation, program data | 20 Participants |
| Mobilization Tool Arm | Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | Treatment initiation, self-report | 14 Participants |
| Comparator Tool Arm | Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | Treatment initiation, program data | 8 Participants |
| Comparator Tool Arm | Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report | Treatment initiation, self-report | 8 Participants |