Move and Moderate in Balance

Obesity Clinical Trial

— MOVE'M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715130
• Other study ID #: FHCRC-6334
• Secondary ID: U54CA116847
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: December 6, 2011
• Start date: September 2005
• Est. completion date: August 2010

Study information

• Verified date: December 2011
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Overweight
• Sedentary

Intervention

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.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.		At study conclusion	No
Secondary	Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.		At study conclusion	No