Move and Moderate in Balance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study

Conditions
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Overweight, Obesity, Sedentary

Intervention / Treatment
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* Behavioral: Energy Balance


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Energy Balance|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Our main outcome measure is change in body mass index, as an aggregated value at the worksite level. |  | At study conclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites. |  | At study conclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy, Obesity, Energy Balance, Physical Activity, Dietary Intake, Overweight, Sedentary, Worksite, Body Mass Index, Weight Maintenance