Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

Obesity Clinical Trial

Official title:

Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708121
• Other study ID #: IRB201701301-N
• Secondary ID: 1K23HL127334Pro0
• Status: Completed
• Phase: N/A
• Start date: March 3, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: June 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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:
• Comparator Intervention
Participants informed that they have access to weight loss treatment.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Duke University, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Number of Participants Attending 6 Month Follow-up Appointment	Count of enrolled participants who attend 6 month follow-up appointment	6 months
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.	1 month