- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01880060
Tailored Worksite Weight Control Programs
June 2, 2023 updated by: Virginia Polytechnic Institute and State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will test the utility of a social ecological theory, individually-targeted internet-based intervention with monetary incentives to reduce the weight of overweight and obese employees (INCENT) when compared to a low-intensity, internet-based weight loss program without incentives (Livin My Weigh).
Participants in INCENT will receive daily e-mail support that facilitates goal setting, regular assessments of body weight, and incentives based on percent of original body weight lost at the end of each quarter over the 12-month program.
The e-mail supports will target improving perceptions of self-efficacy and outcome expectations related to weight loss or maintaining a healthy weight.
In addition e-mail support will facilitate participant problem solving and identification of resources for healthful eating and physical activity at home, in their neighborhoods, and at their worksite.
Participants in Livin My Weigh (LMW)will receive evidence-based physical activity and nutrition information to facilitate weight loss through quarterly newsletters and quarterly educational sessions.
Study Type
Interventional
Enrollment (Actual)
1790
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Employed full time at an eligible worksite
- Access to the internet
- BMI > 25
Exclusion Criteria:
- BMI < 25
- no internet access
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INCENT weight loss program
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.
|
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.
|
|
Experimental: Livin My Weigh
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reach and representativeness of participants in the INCENT intervention
Time Frame: 12 months
|
Determine the reach (participation rate and representativeness)of the INCENT intervention.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Loss
Time Frame: 6 and 12 months
|
Determine, using a cluster (worksite) 2 group randomized design, if the INCENT intervention will produce objectively verified decreases in body weight in the short term (6 months) and enhance longer-term (12 months) weight control for overweight and obese employees when compared to control.
|
6 and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Measure of Intervention Costs
Time Frame: 12 months
|
Evaluate the cost and cost effectiveness of each intervention arm based on: A) cost per 5% reduction in body weight, B) cost per unit changes in productivity and absenteeism.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Paul A Estabrooks, Ph.D., Virginia Polytechnic Institute and State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 17, 2013
First Posted (Estimated)
June 18, 2013
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 2, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01DK071664-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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