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Move and Moderate in Balance

NCT ID: NCT00715130

Last Updated: 2011-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-08-31

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:

1. Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
2. Assess changes in individual level physical activity and energy intake attributable to the intervention
3. Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
4. Estimate the cost-effectiveness of the intervention in controlling weight.

Conditions

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Overweight Obesity Sedentary

Keywords

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Energy Obesity Energy Balance Physical Activity Dietary Intake Overweight Sedentary Worksite Body Mass Index Weight Maintenance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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dietary intake energy expenditure energy intake physical activity

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Fred Hutchinson Cancer Research Center

Principal Investigators

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Shirley AA Beresford, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Anne McTiernan, MD, PhD

Role: STUDY_DIRECTOR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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U54CA116847

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHCRC-6334

Identifier Type: -

Identifier Source: org_study_id