Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Motivational Intervention
* Other: Comparator Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment. | Behavioral: Motivational Intervention<br>* 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.<br>* Other names: Your Wellness Prescription;|
| Active Comparator: Comparator Arm<br>Participant receives access to weight loss treatment alone. | Other: Comparator Intervention<br>* Participants informed that they have access to weight loss treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Attending 6 Month Follow-up Appointment | Count of enrolled participants who attend 6 month follow-up appointment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month |