NCT00707577

Brief Summary

This research study is being done: 1) to determine if the MGH Be Fit program helps employees to change their nutrition and exercise habits and lower their risk for chronic diseases, such as heart disease and diabetes and 2) to determine if a maintenance program following the Be Fit 12 week program will help employees to keep the positive health changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2008

Longer than P75 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

Study Start

First participant enrolled

February 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2008

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

March 1, 2017

Enrollment Period

6.6 years

First QC Date

June 27, 2008

Results QC Date

March 21, 2017

Last Update Submit

March 21, 2017

Conditions

ObesityOverweight

Keywords

Worksite WellnessWeight loss and maintenancePhysical ActivityHealth and Fitness interventionsHealthy eatingWeight lossMaintenance programs

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    Mean number of pounds lost at the end of the 10-week program and 9-month maintenance program

    1 year

Study Arms (2)

Internet-based maintenance program

EXPERIMENTAL

9-month Internet based self-monitoring maintenance program to track weight, exercise, and food logs

Behavioral: Internet-based maintenance program

Control

NO INTERVENTION

No maintenance program provided

Interventions

Internet-based maintenance programBEHAVIORAL

The Be Fit maintenance program is a randomized controlled trial of a 9 month intervention to maintain weight loss and physical activity after completion of the 12 week wellness program. Six teams of 25 participants will be randomized to the intervention or to usual care. There are 2 key elements to the maintenance program: personal contact and Internet contact. The personal contact enables the participants to continue receiving face-to-face support from a Be Fit nutritionist and trainer. The Internet interface is an opportunity for the participants to self-monitor their own progress while still under the guidance of the program.

Internet-based maintenance program

Eligibility Criteria

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

You may qualify if:

  • MGH (benefited) employees who enroll in the Be Fit program
  • Able to commit to 1 year of active research participation

You may not qualify if:

  • Not enrolled in the Be Fit program
  • Decline participation in the research study
  • Withdrawal from the Be Fit 12 week program prior to completion
  • Women who are currently pregnant or suspect they may be pregnant
  • Plans to leave MGH within 3 months from enrolling in Be Fit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Thorndike AN, Sonnenberg L, Healey E, Myint-U K, Kvedar JC, Regan S. Prevention of weight gain following a worksite nutrition and exercise program: a randomized controlled trial. Am J Prev Med. 2012 Jul;43(1):27-33. doi: 10.1016/j.amepre.2012.02.029.

    PMID: 22704742RESULT

MeSH Terms

Conditions

ObesityOverweightWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Results Point of Contact

Title
Dr. Anne Thorndike
Organization
Massachusetts General Hospital
athorndike@mgh.harvard.edu
617-724-4608

Study Officials

  • Anne N Thorndike, MD, MPH

    Massachusetts General Hospital

    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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 1, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 1, 2017

Results First Posted

May 1, 2017

Record last verified: 2017-03

Locations

US(1)