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Weight LossNCT00481715

Comparison of Two Workplace-Sponsored Obesity Prevention Programs

A study testing Web-Based Weight Loss Program and Cash Incentive Weight Loss Program in people with Weight Loss, run by University of North Carolina, Chapel Hill.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Obesity has reached epidemic proportions in the United States with nearly 64% of American adults considered overweight or obese. Weight loss programs that take place at work have proven to be effective at promoting healthy lifestyles. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Weight Loss
What is being tested?
Web-Based Weight Loss Program and Cash Incentive Weight Loss Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,020 participants
Where
No sites listed yet
Study dates
Sep 2008to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body mass index (BMI) greater than or equal to 25
  • Current FT employee and member of the State Health Plan in North Carolina

Who cannot join

  • Pregnant or breastfeeding
  • Type 1 diabetes
  • Currently taking weight loss medication
  • Lacks internet access at work or home
  • Previous weight loss surgery or plans to have weight loss surgery
  • Answers "Yes" to any of the Physical Activity Readiness Questionnaire questions
  • Known history of stroke, coronary heart disease, or type 2 diabetes, or possesses a BMI of 42 or higher AND does not have a medical clearance from a physician

About this study

Official title: Interventions to Control Obesity in Colleges

Obesity has reached epidemic proportions in the United States with nearly 64% of American adults considered overweight or obese. Weight loss programs that take place at work have proven to be effective at promoting healthy lifestyles. The purpose of this study is to compare the effectiveness of a Web-based weight loss program versus a cash incentive weight loss program among employees at North Carolina universities and colleges.

Read the detailed description

Obesity, which leads to higher rates of diabetes, cancer, and heart disease, is an increasingly important public health problem. Evidence suggests that the effects of poor diet and physical inactivity will soon overtake smoking as the leading cause of death. Obesity-attributable medical expenses account for 9.1% of the total annual medical expenditures in the United States, and may be as high as $78.5 billion. In North Carolina, obesity accounts for more than $2 billion annually in increased medical spending and nearly half of this total is financed through employer-provided health insurance. Weight loss programs that take place at work have demonstrated the ability to improve both employee health and the financial health of the company. However, few weight loss programs have been evaluated and implemented in the workplace. The purpose of this study is to compare the effectiveness of a Web-based weight loss program versus a cash incentive weight loss program among employees at universities and colleges in North Carolina.

This study will enroll approximately 1200 employees from 12 universities and colleges in North Carolina. Each university or college will be randomly assigned to one of the following four groups: 1) a Web-based weight loss program, 2) a cash incentive weight loss program, 3) the Web-based program plus the cash incentive program, or 4) neither program. Participants in the Web-based weight loss program will take part in a weekly Web-based weight control program that is comprehensive, individually focused, self-directed, and includes both weight loss and weight gain prevention information. In the cash incentive program, participants will receive a cash payment if they lose a pre-determined amount of weight at each follow-up weigh in. At baseline and Months 3, 6, 12, and 18, all participants will be weighed, body fat measurements will occur, and information on physical activity levels, eating behaviors, quality of life, work productivity, and medical expenses will be collected. During this study, study researchers will also monitor changes that occur in the physical and social environment on campus.

Conditions
Weight Loss
Being tested
Web-Based Weight Loss Program, Cash Incentive Weight Loss Program
Keywords
Web-Based Weight Loss Program, Cash Incentive Weight Loss Program, North Carolina
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-Based Weight Loss ProgramBehavioural

    Participants will take part in a Web-based weight loss program.

  • Cash Incentive Weight Loss ProgramBehavioural

    Participants will take part in a cash incentive weight loss program.

Study groups in NCT00481715
Study groupRoleWhat they receive
1ExperimentalWeb-based weight loss program
Receives: Behavioral: Web-Based Weight Loss Program
2ExperimentalCash incentive weight loss program
Receives: Behavioral: Cash Incentive Weight Loss Program
3ExperimentalWeb-based program plus the cash incentive program
Receives: Behavioral: Web-Based Weight Loss Program; Behavioral: Cash Incentive Weight Loss Program
4No interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    Measured: Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure

Secondary outcomes (2)
  1. Percentage of body fat; moderate physical activity (PA); moderate/vigorous PA and step counts; total calories consumed; fruits and vegetables consumed; total and saturated fat consumed; overall eating behavior; health related quality of life

    Measured: Measured at Mo 3, 6, 12 and 18 mo

  2. Self-reported health; presenteeism; productivity/work limits; turnover/absenteeism; medical expenditures data; campus changes in the physical/social environment

    Measured: Measured at Mo 3, 6, 12, 18 mo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2007 (estimated)
  2. Study startSep 2008
  3. Primary completionMay 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
1,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00481715
Sponsor's protocol ID
473
Other IDs
R01HL080656-01A1
Status last verified
Jan 2011
First submitted
31 May 2007
Last updated
27 Jan 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Web-Based Weight Loss Program and Cash Incentive Weight Loss Program in people with Weight Loss, run by University of North Carolina, Chapel Hill.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: Measured at Mo 3,6, 12, 18 mo; powered at 12 mo measure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2011.

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