- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715130
Move and Moderate in Balance (MOVE'M)
Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Time Frame: At study conclusion
|
At study conclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Time Frame: At study conclusion
|
At study conclusion
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shirley AA Beresford, PhD, Fred Hutchinson Cancer Center
- Study Director: Anne McTiernan, MD, PhD, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHCRC-6334
- U54CA116847 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Energy Balance
-
Washington University School of MedicineCompletedCardiovascular DiseasesUnited States
-
University of AdelaideCompletedInsulin ResistanceAustralia
-
Leeds Beckett UniversityCompletedEffects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic ResponsesMetabolic Disease | Appetitive BehaviorUnited Kingdom
-
USDA, Western Human Nutrition Research CenterRecruitingObesity | Body WeightUnited States
-
The University of Tennessee, KnoxvilleActive, not recruiting
-
United States Army Research Institute of Environmental...Completed
-
University of HawaiiThe Apex Fitness Group; Bookman Publishing CompanyCompletedOverweight and ObesityUnited States
-
Nancy SchoenbergNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | OverweightUnited States
-
Liverpool John Moores UniversityAlliance for Potato Research and EducationCompletedEnergy Supply; Deficiency | Energy Balance | Energy AvailabilityUnited Kingdom
-
Clinical Nutrition Research Centre, SingaporeUnknownInsulin Resistance | Glucose Intolerance | Insulin Sensitivity | Energy Supply; DeficiencySingapore