Clinical trial NCT00715130: Move and Moderate in Balance
Official title: Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Sedentary
Keywords: Energy
Obesity
Energy Balance
Physical Activity
Dietary Intake
Overweight
Sedentary
Worksite
Body Mass Index
Weight Maintenance
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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)

Primary outcomes:
measure: Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
timeFrame: At study conclusion
Secondary outcomes:
measure: Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
timeFrame: At study conclusion
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Shirley AA Beresford, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Center
name: Anne McTiernan, MD, PhD
role: STUDY_DIRECTOR
References: