Move and Moderate in Balance (MOVE'M)
Primary Purpose
Overweight, Obesity, Sedentary
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Balance
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Energy, Obesity, Energy Balance, Physical Activity, Dietary Intake, Overweight, Sedentary, Worksite, Body Mass Index, Weight Maintenance
Eligibility Criteria
Inclusion Criteria:
- Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)
Exclusion Criteria:
- Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)
Sites / Locations
- Fred Hutchinson Cancer Research Center
Outcomes
Primary Outcome Measures
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Secondary Outcome Measures
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Full Information
NCT ID
NCT00715130
First Posted
July 11, 2008
Last Updated
December 6, 2011
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00715130
Brief Title
Move and Moderate in Balance
Acronym
MOVE'M
Official Title
Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.
Detailed Description
Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:
Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities
Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.
Our primary aim is to:
1) Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.
Our secondary aims are to:
Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
Assess changes in individual level physical activity and energy intake attributable to the intervention
Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
Estimate the cost-effectiveness of the intervention in controlling weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Sedentary
Keywords
Energy, Obesity, Energy Balance, Physical Activity, Dietary Intake, Overweight, Sedentary, Worksite, Body Mass Index, Weight Maintenance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Energy Balance
Other Intervention Name(s)
dietary intake, energy expenditure, energy intake, physical activity
Intervention Description
We propose to develop and test a comprehensive intervention that will provide simple strategies related to dietary intake and energy expenditure that individuals can follow to achieve a balance in their energy intake and expenditure, while simultaneously changing structural and environmental cues to focus on promoting information, social support and opportunities for managing energy intake and increasing physical activity.
Primary Outcome Measure Information:
Title
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Time Frame
At study conclusion
Secondary Outcome Measure Information:
Title
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Time Frame
At study conclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)
Exclusion Criteria:
Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley AA Beresford, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne McTiernan, MD, PhD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Director
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
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Move and Moderate in Balance
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