ObesityNCT01880060
Tailored Worksite Weight Control Programs
A study testing INCENT weight loss program and Livin My Weigh in people with Obesity, run by Virginia Polytechnic Institute and State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity
- What is being tested?
- INCENT weight loss program and Livin My Weigh
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,790 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jul 2012
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Employed full time at an eligible worksite
- Access to the internet
- BMI > 25
Who cannot join
- BMI < 25
- no internet access
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- INCENT weight loss program, Livin My Weigh
- Keywords
- Worksite, weight loss, obesity
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCENT weight loss programBehavioural
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.
Livin My WeighBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Livin My Weigh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach and representativeness of participants in the INCENT intervention
Determine the reach (participation rate and representativeness)of the INCENT intervention.
Measured: 12 months
Secondary outcomes (1)
Weight Loss
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMar 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Paul A Estabrooks, Ph.D., Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880060
- Sponsor's protocol ID
- 5R01DK071664-02
- Other IDs
- 5R01DK071664-02
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2013
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Worksite Weight Control Programs
- ClinicalTrials.gov ID
- NCT01880060
- Acronym / sponsor ID
- 5R01DK071664-02
- Conditions
- Obesity
- Keywords
- Worksite, weight loss, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,790 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of North Carolina, Chapel Hill
- Study start
- Mar 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCENT weight loss program | Experimental | Behavioral: INCENT weight loss programINCENT: 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. |
| Livin My Weigh | Experimental | Behavioral: Livin My WeighLivin 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employed full time at an eligible worksite
- Access to the internet
- BMI > 25
Key exclusion criteria (2 listed)
- BMI < 25
- no internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCENT weight loss programTangible 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. | Behavioural | INCENT weight loss program |
| Livin My WeighLivin 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. | Behavioural | Livin My Weigh |
Primary outcome
Reach and representativeness of participants in the INCENT intervention
Time frame: 12 months
Determine the reach (participation rate and representativeness)of the INCENT intervention.
1 secondary outcome
Weight Loss
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Estabrooks, Ph.D. principal investigator
Virginia Polytechnic Institute and State University
Questions about this trial
What is this clinical trial studying?
A study testing INCENT weight loss program and Livin My Weigh in people with Obesity, run by Virginia Polytechnic Institute and State University.
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 3 inclusion and 2 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 7 Jun 2023. 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?
Reach and representativeness of participants in the INCENT intervention (time frame: 12 months). 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 7 Jun 2023.