ObesityPhase 2/3NCT01467284
School Worksite Weight Gain Prevention Intervention Study
A Phase 2/3 study testing Step Ahead and Basic Intervention in people with Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The proposed site-level randomized trial will test the effectiveness of a work site intervention based on an ecological framework at preventing weight gain among high school employees in Massachusetts. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Step Ahead and Basic Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2014
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- work at least 15 hours per week, or approximately half of the school week,
- only work at one school participating in the study,
- not be in a "leadership" position in the school (e.g. principals and vice-principals)
- be able to stand up
- speak English
- plan to be employed at the school for the next 24 months
Who cannot join
- work less than 15 hours per week
- work at more than one participating school
- work in a "leadership" position (e.g. principal or vice-principal)
- does not speak English
- unable to stand up
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
The proposed site-level randomized trial will test the effectiveness of a work site intervention based on an ecological framework at preventing weight gain among high school employees in Massachusetts. The investigators hypothesis is that the intervention will positively impact healthy dietary patterns and physical activity, perceived organizational commitment, coworker influences, social support, self-efficacy, and self-control, which in turn will positively mediate or moderate the positive associations between the intervention and the primary outcomes (change in weight, BMI, and waist circumference). If effective, the intervention is designed to be generalizable to high school settings across the country and has the potential to reduce the morbidity, mortality and economic costs of overweight and obesity in this important population.
- Conditions
- Obesity
- Being tested
- Step Ahead, Basic Intervention
- Keywords
- Obesity, Workplace, Intervention, Diet, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step AheadBehavioural
Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level.
Basic InterventionBehavioural
Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention.
| Study group | Role | What they receive |
|---|---|---|
| Step Ahead | Experimental | Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level. Receives: Behavioral: Step Ahead |
| Basic Intervention | Active comparator | Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention. Receives: Behavioral: Basic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
High school employee change in weight
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in weight among high school employees in Massachusetts
Measured: 24 months post-baseline
Secondary outcomes (4)
High school employee change in BMI
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in BMI among high school employees in Massachusetts
Measured: 24 months post-baseline
High School employee change in waist circumference
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in waist circumference among high school employees in Massachusetts
Measured: 23 months post-baseline
Weight management behaviors
Test the effectiveness of a worksite intervention compared to the control condition on physical activity and healthy eating behaviors among high school employees in Massachusetts.
Measured: 24 months post-baseline
High school employee absenteeism
Test the effectiveness of a work site intervention based on an ecological framework at preventing absenteeism among high school employees in Massachusetts.
Measured: 24 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephenie Lemon, University of Massachusetts, Worcester
- Investigators
- Stephenie Lemon, PhD, Principal investigator, University of Massachusetts, WorcesterLori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467284
- Sponsor's protocol ID
- R01CA132941
- Status last verified
- Jul 2014
- First submitted
- 7 Oct 2011
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang ML, Haughton CF, Frisard C, Pbert L, Geer C, Lemon SC. Perceived weight status and weight change among a U.S. adult sample. Obesity (Silver Spring). 2017 Jan;25(1):223-228. doi: 10.1002/oby.21685. Epub 2016 Nov 15.
PubMed 27863126Alker HJ, Wang ML, Pbert L, Thorsen N, Lemon SC. Impact of school staff health on work productivity in secondary schools in Massachusetts. J Sch Health. 2015 Jun;85(6):398-404. doi: 10.1111/josh.12266.
PubMed 25877437
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Worksite Weight Gain Prevention Intervention Study
- ClinicalTrials.gov ID
- NCT01467284
- Acronym / sponsor ID
- R01CA132941
- Conditions
- Obesity
- Keywords
- Obesity, Workplace, Intervention, Diet, Exercise
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Nov 2011 (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.
The proposed site-level randomized trial will test the effectiveness of a work site intervention based on an ecological framework at preventing weight gain among high school employees in Massachusetts. The investigators hypothesis is that the intervention will positively impact healthy dietary patterns and physical activity, perceived organizational commitment, coworker influences, social support, self-efficacy, and self-control, which in turn will positively mediate or moderate the positive associations between the intervention and the primary outcomes (change in weight, BMI, and waist circumference). If effective, the intervention is designed to be generalizable to high school settings across the country and has the potential to reduce the morbidity, mortality and economic costs of overweight and obesity in this important population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step Ahead | Experimental | Behavioral: Step AheadPromotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level. |
| Basic Intervention | Active comparator | Behavioral: Basic InterventionPromotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- work at least 15 hours per week, or approximately half of the school week,
- only work at one school participating in the study,
- not be in a "leadership" position in the school (e.g. principals and vice-principals)
- be able to stand up
- speak English
Key exclusion criteria (5 listed)
- work less than 15 hours per week
- work at more than one participating school
- work in a "leadership" position (e.g. principal or vice-principal)
- does not speak English
- unable to stand up
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 |
|---|---|---|
| Step AheadPromotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level. | Behavioural | Step Ahead |
| Basic InterventionPromotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention. | Behavioural | Basic Intervention |
Primary outcome
High school employee change in weight
Time frame: 24 months post-baseline
Test the effectiveness of a worksite intervention based on an ecological framework at preventing an increase in weight among high school employees in Massachusetts
4 secondary outcomes
High school employee change in BMI
Time frame: 24 months post-baseline
High School employee change in waist circumference
Time frame: 23 months post-baseline
Weight management behaviors
Time frame: 24 months post-baseline
High school employee absenteeism
Time frame: 24 months post-baseline
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 18 Jul 2014.
- Derived from this study: PubMed 27863126Wang ML, Haughton CF, Frisard C, Pbert L, Geer C, Lemon SC. Perceived weight status and weight change among a U.S. adult sample. Obesity (Silver Spring). 2017 Jan;25(1):223-228. doi: 10.1002/oby.21685. Epub 2016 Nov 15.
- Derived from this study: PubMed 25877437Alker HJ, Wang ML, Pbert L, Thorsen N, Lemon SC. Impact of school staff health on work productivity in secondary schools in Massachusetts. J Sch Health. 2015 Jun;85(6):398-404. doi: 10.1111/josh.12266.
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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.
Stephenie Lemon, PhD principal investigator
University of Massachusetts, Worcester
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Step Ahead and Basic Intervention in people with Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
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 6 inclusion and 5 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
High school employee change in weight (time frame: 24 months post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467284, which also lists 2 linked publications.
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 18 Jul 2014.