Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

NCT ID: NCT02708121

Last Updated: 2019-06-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2018-02-23

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Staff recruiting participants and doing outcomes assessment will remain blinded to treatment assignment

Study Groups

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Intervention arm

Participant receives intervention to motivate weight loss treatment initiation and access to weight loss treatment.

Group Type EXPERIMENTAL

Motivational Intervention

Intervention Type 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.

Comparator Arm

Participant receives access to weight loss treatment alone.

Group Type ACTIVE_COMPARATOR

Comparator Intervention

Intervention Type OTHER

Participants informed that they have access to weight loss treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

Comparator Intervention

Participants informed that they have access to weight loss treatment.

Intervention Type OTHER

Other Intervention Names

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Your Wellness Prescription

Eligibility Criteria

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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


* 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.

Exclusion Criteria

* In weight loss treatment program in past year
* Unable to read content on websites without any assistance
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan A McVay, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31586443 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1K23HL127334

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00079803

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201701301-N

Identifier Type: -

Identifier Source: org_study_id

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