Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tailored Worksite Weight Control Programs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880060
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : July 16, 2013
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Paul Estabrooks, Virginia Polytechnic Institute and State University

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 18, 2013
Last Update Posted Date July 16, 2013
Study Start Date  ICMJE March 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Reach and representativeness of participants in the INCENT intervention [ Time Frame: 12 months ]
Determine the reach (participation rate and representativeness)of the INCENT intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01880060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2013)
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.
Original Other Pre-specified Outcome Measures
 (submitted: June 17, 2013)
Cost and cost effectiveness of each intervention arm [ 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.
 
Descriptive Information
Brief Title  ICMJE Tailored Worksite Weight Control Programs
Official Title  ICMJE Tailored Worksite Weight Control Programs
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Behavioral: INCENT weight loss program
    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.
  • Behavioral: Livin My Weigh
    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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: INCENT weight loss program
  • 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.
    Intervention: Behavioral: Livin My Weigh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
1790
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI < 25
  • no internet access
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880060
Other Study ID Numbers  ICMJE 5R01DK071664-02( U.S. NIH Grant/Contract )
5R01DK071664-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Estabrooks, Virginia Polytechnic Institute and State University
Study Sponsor  ICMJE Virginia Polytechnic Institute and State University
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of North Carolina, Chapel Hill
Investigators  ICMJE
Principal Investigator: Paul A Estabrooks, Ph.D. Virginia Polytechnic Institute and State University
PRS Account Virginia Polytechnic Institute and State University
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP