NCT01880060

Brief Summary

Given the prevalence of overweight and obesity, worksite-based health promotion programs have been recommended due to their potential reach and social support impact. Within worksite contexts, many strategies to prevent and treat obesity have focused on educational programs delivered in person or to small groups that target knowledge acquisition and strategies targeted at individuals to improve their dietary and activity practices. These programs have been criticized because they typically reach a small percentage of workers-and seldom those that could benefit most, are of short duration, and have typically small effects that are not sustained. They have also typically been conducted in large worksites that have the greatest resources. The lack of success of these programs may be due to: 1) inadequate intervention intensity, 2) implementation challenges, and 3) a lack of theoretical models as the bases for intervention development. To overcome the limitations of previous research we will conduct a 2 group randomized controlled trial to determine the reach and effectiveness of an extensive intervention that: (a) is based upon sound theory, (b) is delivered primarily through scalable interactive technologies, and (c) leverages the existing organizational and environmental context of the workplace.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,790

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable obesity

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

March 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4.3 years

First QC Date

June 13, 2013

Last Update Submit

June 2, 2023

Conditions

Keywords

Worksiteweight lossobesity

Outcome Measures

Primary Outcomes (1)

  • Reach and representativeness of participants in the INCENT intervention

    Determine the reach (participation rate and representativeness)of the INCENT intervention.

    12 months

Secondary Outcomes (1)

  • Weight Loss

    6 and 12 months

Other Outcomes (1)

  • Composite Measure of Intervention Costs

    12 months

Study Arms (2)

INCENT weight loss program

EXPERIMENTAL

INCENT: The INCENT intervention is an internet-delivered weight loss program with periodic financial incentives for weight loss. INCENT participants receive daily e-mail support with nutritional and physical activity suggestions to enhance weight loss. Monetary incentives are earned on a quarterly basis for weight loss and participants receive monthly checks that reflect the percent weight loss. A regularly calibrated scale with a built in digital camera captures an image of the participant during a weigh-in, and is used to objectively obtain weight data from participants at each quarterly weigh-in.

Behavioral: INCENT weight loss program

Livin My Weigh

EXPERIMENTAL

Livin My Weigh: The Livin My Weigh (LMW) intervention is an internet-delivered weight loss program without daily support or financial incentives. Participants receive quarterly newsletters with tips on weight loss, increasing physical activity, and menu suggestions, and optional quarterly educational sessions. Weight is measured in the same manner as the INCENT participants.

Behavioral: Livin My Weigh

Interventions

Tangible incentives seem to be effective in enhancing short term, but not long-term weight loss. The monetary rewards are based on participant quarterly weigh-ins and the monetary amount of incentive will be identical to the percentage of body weight lost. Participants who lose 1, 2, 3, 4, or 5% of their body weight will then be compensated with 1, 2, 3, 4, or 5 dollars per month. Dollar amounts for participants that lose more than 5% of initial body weight then increase by increments of 5 (e.g., 5-9% weight loss = $5; 10-14%=$10; 15-19%=$15; \>20%=$20). These incentives will be based on quarterly weight and all percentage weight loss is calculated based on a participant's initial weight. commencement). Participants receive monthly checks that reflect the percent weight loss.

INCENT weight loss program
Livin My WeighBEHAVIORAL

Livin My Weigh is an internet-delivered weight loss program without daily support or financial incentives. Participants receive quarterly newsletters with tips on weight loss, increasing physical activity, and menu suggestions, and optional quarterly educational sessions. Weight is measured in the same manner as the INCENT participants.

Livin My Weigh

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employed full time at an eligible worksite
  • Access to the internet
  • BMI \> 25

You may not qualify if:

  • BMI \< 25
  • no internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Paul A Estabrooks, Ph.D.

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

March 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 7, 2023

Record last verified: 2023-06