OverweightMOVE'MNCT00715130
Move and Moderate in Balance
A study testing Energy Balance in people with Overweight and Obesity, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Sedentary
- What is being tested?
- Energy Balance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 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
- Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)
Who cannot join
- Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study
H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.
Read the detailed description
Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:
- Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities
- Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.
Our primary aim is to:
- Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.
Our secondary aims are to:
- Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
- Assess changes in individual level physical activity and energy intake attributable to the intervention
- Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
- Estimate the cost-effectiveness of the intervention in controlling weight.
- Conditions
- Overweight, Obesity, Sedentary
- Being tested
- Energy Balance
- Keywords
- Energy, Obesity, Energy Balance, Physical Activity, Dietary Intake, Overweight, Sedentary, Worksite, Body Mass Index, Weight Maintenance
- Medical subject headings
- Overweight, Obesity, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy BalanceBehavioural
Also called dietary intake, energy expenditure, energy intake, physical activity
We propose to develop and test a comprehensive intervention that will provide simple strategies related to dietary intake and energy expenditure that individuals can follow to achieve a balance in their energy intake and expenditure, while simultaneously changing structural and environmental cues to focus on promoting information, social support and opportunities for managing energy intake and increasing physical activity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Measured: At study conclusion
Secondary outcomes (1)
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Measured: At study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startSep 2005
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Shirley AA Beresford, PhD, Principal investigator, Fred Hutchinson Cancer CenterAnne McTiernan, MD, PhD, Study director, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715130
- Sponsor's protocol ID
- FHCRC-6334
- Other IDs
- U54CA116847
- Acronym
- MOVE'M
- Status last verified
- Dec 2011
- First submitted
- 11 Jul 2008
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move and Moderate in Balance (MOVE'M): A TREC Worksite Health Study
- ClinicalTrials.gov ID
- NCT00715130
- Acronym / sponsor ID
- MOVE'M / FHCRC-6334
- Conditions
- Overweight, Obesity, Sedentary
- Keywords
- Energy, Obesity, Energy Balance, Physical Activity, Dietary Intake, Overweight, Sedentary, Worksite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 15 Jul 2008 (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.
H1: The increase in body mass index between baseline and two year follow-up among intervention worksites will be lower than that among control worksites, such that the differential change will be negative on average.
Detailed description
Our overall objective is to develop and evaluate an intervention that will maintain or decrease body mass index; specifically, we will recruit and randomize 30 worksites to a two year intervention in which we will:
- Influence the worksite environment, including policies and procedures, by increasing worksite access to healthy foods and physical activity opportunities
- Promote individual behavior change, through increasing awareness of energy balance; building a physical activity intervention that will promote increased levels of energy expenditure through the combination of increased daily physical activity and regular, structured exercise; and building a dietary intervention that will promote decreased calorie intake.
Our primary aim is to:
- Evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites.
Our secondary aims are to:
- Assess changes in worksite environment in access to healthy foods and physical activity opportunities attributable to the intervention
- Assess changes in individual level physical activity and energy intake attributable to the intervention
- Assess the changes in sequalae of weight loss including biomarkers of metabolic effects, and weight loss quality of life and symptom measures; and
- Estimate the cost-effectiveness of the intervention in controlling weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employees of the enrolled worksite who are 18 years or older and work at the company at least 50% FTE (20 hrs per week)
Key exclusion criteria (1 listed)
- Any employees of the enrolled worksite who are interns or seasonal workers or employees who work less than 50% FTE (20 hrs per week)
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 |
|---|---|---|
| Energy BalanceAlso: dietary intake, energy expenditure, energy intake, physical activityWe propose to develop and test a comprehensive intervention that will provide simple strategies related to dietary intake and energy expenditure that individuals can follow to achieve a balance in their energy intake and expenditure, while simultaneously changing structural and environmental cues to focus on promoting information, social support and opportunities for managing energy intake and increasing physical activity. | Behavioural | – |
Primary outcome
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level.
Time frame: At study conclusion
1 secondary outcome
Secondary, process measures will be of physical activity, physical fitness and calorie intake, at the individual level, within worksites.
Time frame: At study conclusion
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 Dec 2011.
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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.
Shirley AA Beresford, PhD principal investigator
Fred Hutchinson Cancer Center
Anne McTiernan, MD, PhD study director
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Balance in people with Overweight and Obesity, run by Fred Hutchinson Cancer Center 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 1 inclusion and 1 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 Dec 2011. 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.
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?
Our main outcome measure is change in body mass index, as an aggregated value at the worksite level. (time frame: At study conclusion). 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 Dec 2011; AzTrials last refreshed its copy on 30 Oct 2026.