Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Motivational Intervention; Other: Comparator Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.	Behavioral: 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.; Other Names: Your Wellness Prescription
Active Comparator: Comparator Arm; Participant receives access to weight loss treatment alone.	Other: Comparator Intervention; Participants informed that they have access to weight loss treatment.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Duke University
• Investigators: Principal Investigator: Megan A McVay, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2017
• Primary Completion (Actual): February 23, 2018
• Study Completion (Actual): February 23, 2018

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: IRB201701301-N; 1K23HL127334 (U.S. NIH Grant/Contract); Pro00079803 (Other Identifier: Duke Unversity)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No