Back to resultsIncreasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Intervention
Comparator Intervention
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention arm
Comparator Arm
Arm Description
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Participant receives access to weight loss treatment alone.
Outcomes
Primary Outcome Measures
Number of Participants Attending 6 Month Follow-up Appointment
Count of enrolled participants who attend 6 month follow-up appointment
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02708121
First Posted
March 10, 2016
Last Updated
June 21, 2019
Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Duke University
1. Study Identification
Unique Protocol Identification Number
NCT02708121
Brief Title
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Official Title
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Staff recruiting participants and doing outcomes assessment will remain blinded to treatment assignment
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.
Arm Title
Comparator Arm
Arm Type
Active Comparator
Arm Description
Participant receives access to weight loss treatment alone.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Intervention
Other Intervention Name(s)
Your Wellness Prescription
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comparator Intervention
Intervention Description
Participants informed that they have access to weight loss treatment.
Primary Outcome Measure Information:
Title
Number of Participants Attending 6 Month Follow-up Appointment
Description
Count of enrolled participants who attend 6 month follow-up appointment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intervention Acceptability (Acceptability Outcome)
Description
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
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan A McVay, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31586443
Citation
McVay MA, Yancy WS, Bennett GG, Levine E, Jung SH, Jung S, Anton S, Voils CI. A web-based intervention to increase weight loss treatment initiation: results of a cluster randomized feasibility and acceptability trial. Transl Behav Med. 2021 Feb 11;11(1):226-235. doi: 10.1093/tbm/ibz143.
Results Reference
derived
Learn more about this trial
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
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