NCT01282775

Brief Summary

CDC WAY to Health is a three year, group-randomized weight loss intervention study where approximately 1020 overweight/obese employees nested within 17 community colleges are randomly assigned to receive one of three promising, state-of-the-art, theory-linked interventions: Environment/Usual Care (E); Web-based Weight Loss Program + Environment (WEB+E) or Web + Environment +Incentives (WEB+E+I). College is the unit of randomization and intervention; employee is the unit of analysis. Follow-up weigh-in assessments are conducted at 3, 6, and 12 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,029

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
Last Updated

January 25, 2011

Status Verified

January 1, 2011

Enrollment Period

1.2 years

First QC Date

January 20, 2011

Last Update Submit

January 21, 2011

Conditions

Keywords

overweightobesityworksite

Outcome Measures

Primary Outcomes (1)

  • weight change

    participants weight change will be analyzed at 12 months compared to baseline

    3, 6, and 12 months

Secondary Outcomes (7)

  • moderate vigorous physical activity

    3, 6, and 12 months

  • total calories

    3, 6, and 12 months

  • percent body fat

    3, 6, and 12 months

  • fruit/veg intake

    3, 6, and 12 months

  • absenteeism

    3, 6, and 12 months

  • +2 more secondary outcomes

Study Arms (3)

Environment / Usual Care

NO INTERVENTION

WEB+ Environment

OTHER

Web-based weight loss program (WEB) + Environment - Participants have access to a proven Web-based weight loss program with weekly lessons focused on lifestyle behavior changes

Behavioral: WEB + Environment

WEB + Cash Incentive for Weight Loss

OTHER

Web-based Weight Loss Program + Cash Incentive for Weight Loss - participants have access to a proven web-based weight loss program plus they are paid cash based on the percent weight lost at 12 months compared to baseline.

Behavioral: WEB + EnvironmentBehavioral: WEB + Cash Incentive for Weight Loss

Interventions

Participants receive weekly lessons via the Web along with additional tools for weight loss support

Also known as: Web-based Weight Loss Program
WEB + Cash Incentive for Weight LossWEB+ Environment

Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.

Also known as: Web-based weight loss program + Cash incentive
WEB + Cash Incentive for Weight Loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI greater than or equal to 25

You may not qualify if:

  • Type I diabetes
  • Pregnant or lactating
  • Had a recent weight loss of 20 pounds or more
  • Currently taking weight loss medication or unwilling to stop
  • Undergone or scheduled weight loss surgery
  • Experienced a malignancy requiring chemotherapy or radiation in the past five years
  • No internet access
  • Answered "yes" to the PAR-Q items and did not return a required physician's consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesity

Interventions

Environment

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Laura A Linnan, ScD, CHES

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 25, 2011

Study Start

September 1, 2005

Primary Completion

November 1, 2006

Study Completion

March 1, 2007

Last Updated

January 25, 2011

Record last verified: 2011-01