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OpenTrials
Completed

NCT Number: NCT02708121

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Intervention

Behavioral

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

Comparator Intervention

Other

Participants informed that they have access to weight loss treatment.

Primary outcomes

  1. Number of Participants Attending 6 Month Follow-up Appointment

    Time frame: 6 months

    Count of enrolled participants who attend 6 month follow-up appointment

Secondary outcomes

  1. Intervention Acceptability (Acceptability Outcome)

    Time frame: 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 outcomes

  1. Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2016
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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