NCT01480466

Brief Summary

Overweight and obesity are highly significant clinical and public health issues, affecting more than two-thirds of adults in this country; however, primary care clinicians often do not document overweight or obesity or discuss weight management with their patients. The objectives of the proposed research are to develop and evaluate a set of tools within electronic health records (EHRs) to assist primary care clinicians with the diagnosis and treatment of overweight and obesity and to help patients manage their weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65,278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration 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

November 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

November 21, 2011

Last Update Submit

April 28, 2014

Conditions

OverweightObesity

Keywords

OverweightObesityBody mass indexWeightPrimary care

Outcome Measures

Primary Outcomes (2)

  • weight change over 6 months

    Change in weight from first visit during Stage 2 of intervention period until approximately 6 months later, among patients with BMI \>= 25

    Baseline, 6 months

  • weight change over 12 months

    Change in weight from first visit during Stage 2 of intervention period until approximately 12 months later, among patients with BMI \>= 25

    Baseline, 12 months

Secondary Outcomes (5)

  • Documentation of height

    Baseline, 6 months, 12 months

  • Documentation of weight

    Baseline, 6 months, 12 months

  • Documentation of body mass index

    Baseline, 6 months, 12 months

  • Diagnosis of overweight and obesity

    Baseline, 6 months, 12 months

  • Management of overweight and obesity

    Baseline, 6 months, 12 months

Other Outcomes (2)

  • Primary care clinician attitudes about management of overweight and obesity

    baseline, 12 months

  • Patient attitudes and behaviors around weight management

    baseline, 6 months

Study Arms (2)

Obesity tools in electronic health record

EXPERIMENTAL

This arm will consist of a new set of tools within the electronic health record to help primary care clinicians address overweight and obesity with their patients.

Other: Obesity tools in the electronic health record

Standard care

NO INTERVENTION

This arm is standard care for overweight/obesity.

Interventions

Obesity tools in the electronic health recordOTHER

The intervention is a set of new tools within the Partners electronic health record that are designed to assist primary care clinicians with the assessment and management of overweight and obesity in their patients.

Obesity tools in electronic health record

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients (ages \>= 20 years) who have a visit at a primary care practice at Brigham and Women's Hospital during the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Baer HJ, Wee CC, DeVito K, Orav EJ, Frolkis JP, Williams DH, Wright A, Bates DW. Design of a cluster-randomized trial of electronic health record-based tools to address overweight and obesity in primary care. Clin Trials. 2015 Aug;12(4):374-83. doi: 10.1177/1740774515578132. Epub 2015 Mar 25.

    PMID: 25810449DERIVED

MeSH Terms

Conditions

OverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heather J Baer, ScD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Epidemiologist

Study Record Dates

First Submitted

November 21, 2011

First Posted

November 29, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 29, 2014

Record last verified: 2014-04

Locations

US(1)