Trial Outcomes & Findings for Environmental Intervention for Weight Gain Prevention (NCT NCT00708461)

NCT ID: NCT00708461

Last Updated: 2019-11-01

Results Overview

Assessed in kilograms per meter squared.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1747 participants
• Primary outcome timeframe: Baseline to 24 months
• Results posted on: 2019-11-01

Participant Flow

Participants were recruited at worksites between January 2006 and April 2007. Human resources departments provided worksite contact information for all eligible employees; these email addresses and phone numbers were used for recruitment contact purposes.

A company-wide email was sent to eligible employees at all sites, describing the study and the partnership with the University. Employees were notified that a study staff member would contact them about the project within the next two weeks and were given the option to call study staff in advance to opt out or to enroll in the study.

Participant milestones

Measure	Worksite Environmental Intervention Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention	No-contact Control No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
Overall Study STARTED	752	995
Overall Study COMPLETED	611	795
Overall Study NOT COMPLETED	141	200

Reasons for withdrawal

Measure	Worksite Environmental Intervention Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention	No-contact Control No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
Overall Study Lost to Follow-up	18	11
Overall Study Withdrawal by Subject	8	9
Overall Study left workforce	115	180

Baseline Characteristics

Environmental Intervention for Weight Gain Prevention

Baseline characteristics by cohort

Measure	Worksite Environmental Intervention n=752 Participants Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention	No-contact Control n=995 Participants No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.	Total n=1747 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=5 Participants	32 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	729 Participants n=5 Participants	954 Participants n=7 Participants	1683 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	42.7 years STANDARD_DEVIATION 10.8 • n=5 Participants	43.1 years STANDARD_DEVIATION 10.6 • n=7 Participants	42.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	478 Participants n=5 Participants	608 Participants n=7 Participants	1086 Participants n=5 Participants
Sex: Female, Male Male	274 Participants n=5 Participants	387 Participants n=7 Participants	661 Participants n=5 Participants
Region of Enrollment United States	752 participants n=5 Participants	995 participants n=7 Participants	1747 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 months

Population: Participants with complete data at baseline and two years, and those who were not pregnant at either time, were retained for analysis.

Assessed in kilograms per meter squared.

Outcome measures

Measure	Worksite Environmental Intervention n=580 Participants Changes to healthy food availability, physical activity opportunities and promotion, body weight scale access, and media enhancements to target weight gain prevention	No-contact Control n=742 Participants No-treatment control condition. Worksites were offered program materials upon completion of programs at intervention sites.
Change in Body Mass Index (BMI)	0.315 kilograms per meter squared Standard Error 0.08959	0.190 kilograms per meter squared Standard Error 0.07987

Adverse Events

Worksite Environmental Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No-contact Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer A. Linde, Ph.D.

University of Minnesota

Phone: 612-624-0065

Email: linde074@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place