NCT01946191

Brief Summary

This randomized trial tested the hypothesis that there would be an incremental benefit of personalized coaching and PCP support in an EHR-based intervention designed to help primary care patients maintain recent intentional weight loss of at least 5%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

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

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

September 16, 2013

Results QC Date

June 26, 2019

Last Update Submit

October 8, 2020

Conditions

Body WeightWeight LossMotor Activity

Keywords

Weight maintenanceElectronic health recordPrimary care

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Weight (kg), change from baseline, Estimate (SE) \[95% confidence interval\]

    Baseline to 24 months

Secondary Outcomes (9)

  • BMI

    Baseline to 24-months

  • Waist Circumference (cm)

    Baseline to 24-months

  • Maintenance of 5% Weight Loss

    Baseline to 24-months

  • Pedometer Steps Per Day

    Baseline to 24 months

  • Physical Component Score (SF-36)

    Baseline to 24-months

  • +4 more secondary outcomes

Other Outcomes (3)

  • Primary Care Provider (PCP) Satisfaction

    12 Months and 30 Months

  • Patient Satisfaction

    12 Months and 30 Months

  • Dietary Score

    Baseline to 24-months

Study Arms (2)

Coaching Group

EXPERIMENTAL

* 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts * Online self-monitoring * Real-time updates to primary care physicians

Behavioral: 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.Behavioral: Online self-monitoringBehavioral: Real-time updates to Primary Care physicians

Tracking Group

ACTIVE COMPARATOR

-Online self-monitoring

Behavioral: Online self-monitoring

Interventions

24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.BEHAVIORAL

Participants were assigned to a specific coach, who contacted the participants via the EHR weekly for 1 month, biweekly in months 2 to 6, monthly in months 7 to 12, and quarterly in months 13 to 24, for a total of 24 scheduled contacts. Coaching group participants received brief questionnaires relevant to weight management, including a text field where they could discuss questions or barriers. On the basis of participant responses and self-monitoring data in the EHR flow sheets, coaches wrote a brief personalized note with advice on questionnaire topics and responses to any queries or barriers mentioned by the participant. Coaching participants who did not complete questionnaires or log information into the flow sheet for 2 weeks were considered inactive and were contacted by telephone or e-mail and invited to reengage at any time. Coaching participants were able to send secure messages to the coach.

Coaching Group
Online self-monitoringBEHAVIORAL

Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.

Coaching GroupTracking Group
Real-time updates to Primary Care physiciansBEHAVIORAL

Referring PCPs of coaching group participants received regular support, including real-time progress reports with counseling tips delivered via the EHR, notification of weight change in increments of at least 10 pounds, and annual progress reports at 12 and 24 months.

Coaching Group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research on Health Care

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

  • Conroy MB, Bryce CL, McTigue KM, Tudorascu D, Gibbs BB, Comer D, Hess R, Huber K, Simkin-Silverman LR, Fischer GS. Promoting weight maintenance with electronic health record tools in a primary care setting: Baseline results from the MAINTAIN-pc trial. Contemp Clin Trials. 2017 Mar;54:60-67. doi: 10.1016/j.cct.2017.01.001. Epub 2017 Jan 12.

    PMID: 28089764RESULT

  • Gibbs BB, Tudorascu D, Bryce CL, Comer D, Fischer GS, Hess R, Huber KA, McTigue KM, Simkin-Silverman LR, Conroy MB. Diet and Physical Activity Behaviors in Primary Care Patients with Recent Intentional Weight Loss. Transl J Am Coll Sports Med. 2017;2(18):114-121. Epub 2017 Sep 15.

    PMID: 29130068RESULT

  • Conroy MB, McTigue KM, Bryce CL, Tudorascu D, Gibbs BB, Arnold J, Comer D, Hess R, Huber K, Simkin-Silverman LR, Fischer GS. Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial. Ann Intern Med. 2019 Dec 3;171(11):777-784. doi: 10.7326/M18-3337. Epub 2019 Nov 12.

    PMID: 31711168RESULT

  • Gibbs BB, Tudorascu D, Bryce CL, Comer D, Fischer GS, Hess R, Huber KA, McTigue KM, Simkin-Silverman LR, Conroy MB. Lifestyle Habits Associated with Weight Regain After Intentional Loss in Primary Care Patients Participating in a Randomized Trial. J Gen Intern Med. 2020 Nov;35(11):3227-3233. doi: 10.1007/s11606-020-06056-x. Epub 2020 Aug 17.

    PMID: 32808209DERIVED

MeSH Terms

Conditions

Body WeightWeight LossMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Limitations and Caveats

1)Single-site trial and study population (26%men and 12%non-white) limits generalizability 2)Staff not blinded, leads to some bias in assessment 4)Missing data introduces potential bias in outcomes 5) 24-month endpoint lead to a shorter intervention

Results Point of Contact

Title
Dr. Molly Conroy
Organization
University of Utah
Molly.Conroy@hsc.utah.edu
801-581-8310

Study Officials

  • Kathleen M McTigue, MD, MPH, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

October 1, 2013

Primary Completion

March 2, 2017

Study Completion

September 5, 2017

Last Updated

November 2, 2020

Results First Posted

November 2, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

Data from this study may be requested by researchers after the completion of the primary endpoint publication by contacting Dr. Conroy.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US(1)