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Completed

NCT Number: NCT00715130

Move and Moderate in Balance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Energy Balance

Behavioral

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.

Other names: dietary intake, energy expenditure, energy intake, physical activity

Primary outcomes

  1. Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.

    Time frame: At study conclusion

Secondary outcomes

  1. Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.

    Time frame: At study conclusion

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: MOVE'M

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Jul 15, 2008
Registry last updated
Dec 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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