NCT02708121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

February 15, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

March 10, 2016

Results QC Date

January 2, 2019

Last Update Submit

June 21, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Attending 6 Month Follow-up Appointment

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

    6 months

Secondary Outcomes (1)

  • Intervention Acceptability (Acceptability Outcome)

    1 month

Other Outcomes (1)

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

    6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Behavioral: Motivational Intervention

Comparator Arm

ACTIVE COMPARATOR

Participant receives access to weight loss treatment alone.

Other: Comparator Intervention

Interventions

Motivational InterventionBEHAVIORAL

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.

Also known as: Your Wellness Prescription
Intervention arm
Comparator InterventionOTHER

Participants informed that they have access to weight loss treatment.

Comparator Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • In weight loss treatment program in past year
  • Unable to read content on websites without any assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • 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.

    PMID: 31586443DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

A fully powered trial is needed to test intervention effectiveness.

Results Point of Contact

Title
Dr. Megan McVay
Organization
Department of Health Education and Behavior, College of Health and Human Performance, University of Florida
megan.mcvay@ufl.edu
(352)294-7029

Study Officials

  • Megan A McVay, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Staff recruiting participants and doing outcomes assessment will remain blinded to treatment assignment
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

March 3, 2017

Primary Completion

February 23, 2018

Study Completion

February 23, 2018

Last Updated

June 25, 2019

Results First Posted

February 15, 2019

Record last verified: 2019-06

Locations

US(1)