NCT01467284

Brief Summary

The proposed site-level randomized trial will test the effectiveness of a work site intervention based on an ecological framework at preventing weight gain among high school employees in Massachusetts. The investigators hypothesis is that the intervention will positively impact healthy dietary patterns and physical activity, perceived organizational commitment, coworker influences, social support, self-efficacy, and self-control, which in turn will positively mediate or moderate the positive associations between the intervention and the primary outcomes (change in weight, BMI, and waist circumference). If effective, the intervention is designed to be generalizable to high school settings across the country and has the potential to reduce the morbidity, mortality and economic costs of overweight and obesity in this important population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
844

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

4.9 years

First QC Date

October 7, 2011

Last Update Submit

July 17, 2014

Conditions

Keywords

ObesityWorkplaceInterventionDietExercise

Outcome Measures

Primary Outcomes (1)

  • High school employee change in weight

    Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in weight among high school employees in Massachusetts

    24 months post-baseline

Secondary Outcomes (4)

  • High school employee change in BMI

    24 months post-baseline

  • High School employee change in waist circumference

    23 months post-baseline

  • Weight management behaviors

    24 months post-baseline

  • High school employee absenteeism

    24 months post-baseline

Study Arms (2)

Step Ahead

EXPERIMENTAL

Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level.

Behavioral: Step Ahead

Basic Intervention

ACTIVE COMPARATOR

Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention.

Behavioral: Basic Intervention

Interventions

Step AheadBEHAVIORAL

Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level.

Step Ahead

Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention.

Basic Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • work at least 15 hours per week, or approximately half of the school week,
  • only work at one school participating in the study,
  • not be in a "leadership" position in the school (e.g. principals and vice-principals)
  • be able to stand up
  • speak English
  • plan to be employed at the school for the next 24 months

You may not qualify if:

  • work less than 15 hours per week
  • work at more than one participating school
  • work in a "leadership" position (e.g. principal or vice-principal)
  • does not speak English
  • unable to stand up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (2)

  • Wang ML, Haughton CF, Frisard C, Pbert L, Geer C, Lemon SC. Perceived weight status and weight change among a U.S. adult sample. Obesity (Silver Spring). 2017 Jan;25(1):223-228. doi: 10.1002/oby.21685. Epub 2016 Nov 15.

  • Alker HJ, Wang ML, Pbert L, Thorsen N, Lemon SC. Impact of school staff health on work productivity in secondary schools in Massachusetts. J Sch Health. 2015 Jun;85(6):398-404. doi: 10.1111/josh.12266.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Stephenie Lemon, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR
  • Lori Pbert, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 7, 2011

First Posted

November 8, 2011

Study Start

July 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations