ObesityPACENCT00119782
Promoting Activity and Changes in Eating (PACE) to Reduce Obesity
A study testing Diet, Exercise and Environment in people with Obesity and Cardiovascular Diseases, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
Reducing the prevalence of obesity in the population is one of the Healthy People 2010 goals. Increased vigilance is required in all age groups in preventing and reversing overweight and obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Diet, Exercise and Environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets specific standard industrial codes
- At least 20% of employees are sedentary
- Willing to provide a list of employees
- Able to achieve at least a 70% response rate to the baseline survey
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center
Seattle, Washington, 91809-1024
About this study
Official title: Reducing Obesity at the Workplace: a Randomized Trial
Reducing the prevalence of obesity in the population is one of the Healthy People 2010 goals. Increased vigilance is required in all age groups in preventing and reversing overweight and obesity. On an individual level, behavioral factors that influence body weight include eating choices leading to excess calorie intake and physical activity patterns leading to diminished calorie expenditure. An imbalance between the two over time leads to increased weight. On a population basis, the prevalence of overweight is associated with a myriad of influences, including social, behavioral, cultural, and environmental factors as well as genetic and physiological factors. For a majority of overweight individuals, restoring a balance between energy intake and expenditure is difficult, and therefore there is an increasing emphasis on preventing obesity on a population level. The long-term goal of this research is to prevent further increase in rates of obesity in the population. In the adult population of working age, a majority of the day is spent in the worksite, suggesting that interventions at the worksite level may offer the opportunity for success in this age group. It is anticipated that this project will yield important contributions to the understanding of obesity prevention.
Read the detailed description
BACKGROUND:
More than half of American adults are overweight or obese, and this proportion is increasing. The health risks associated with obesity include diabetes, cardiovascular disease, arthritis, and some cancers. It is well established that on an individual level, weight gain is caused by taking in more calories than are expended. On a population basis, the prevalence of overweight and obesity is associated with a myriad of influences, including genetic and physiological factors as well as social, behavioral, cultural, and environmental factors. Behavioral factors that contribute to weight gain include eating choices that lead to increased energy intake and physical activity choices that lead to decreased energy expenditure. For a majority of overweight individuals, restoring the balance between energy intake and expenditure is difficult.
DESIGN NARRATIVE:
This study will develop and test a comprehensive intervention involving simple messages that will integrate changes in dietary intake with changes in energy expenditure, while simultaneously modifying structural and environmental factors to promote social support and opportunities for behavioral change. The study will recruit and randomize 48 worksites to a 2-year intervention in which the following will be carried out: build a physical activity intervention combining increased daily physical activity and regular, structured exercise; build a dietary intervention that will promote lower calorie intake; and increase worksite access to both healthy foods and physical activity. The primary aim is to evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites. The study will compare changes in body mass index in intervention versus control worksites using two cross-sectional surveys at baseline and follow-up. Additional assessments using biomarkers and fitness measures will be performed in a subset of employees. The research team has considerable experience with interventions at the worksite level and substantial expertise in obesity prevention.
- Conditions
- Obesity, Cardiovascular Diseases, Heart Diseases
- Being tested
- Diet, Exercise, Environment
- Medical subject headings
- Obesity, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
A dietary intervention that will promote lower calorie intake
ExerciseBehavioural
A physical activity intervention combining increased daily physical activity and regular, structured exercise
EnvironmentBehavioural
Increase worksite access to both healthy foods and physical activity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Comprehensive worksite intervention Receives: Behavioral: Diet; Behavioral: Exercise; Behavioral: Environment |
| 2 | Experimental | Delayed intervention control group Receives: Behavioral: Diet; Behavioral: Exercise; Behavioral: Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: Measured at Month 24 follow-up visit; adjusted for baseline body mass index
Secondary outcomes (1)
Self-reported dietary and physical activity behaviors
Measured: Measured at Month 24 follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startSep 2004
- Primary completionSep 2009
- Study completionNov 2009
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Shirley Beresford, Study chair, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119782
- Sponsor's protocol ID
- 193
- Other IDs
- R01HL079491
- Acronym
- PACE
- Status last verified
- Aug 2012
- First submitted
- 6 Jul 2005
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Obesity at the Workplace: a Randomized Trial
- ClinicalTrials.gov ID
- NCT00119782
- Acronym / sponsor ID
- PACE / 193
- Conditions
- Obesity, Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Jul 2005 (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.
Reducing the prevalence of obesity in the population is one of the Healthy People 2010 goals. Increased vigilance is required in all age groups in preventing and reversing overweight and obesity. On an individual level, behavioral factors that influence body weight include eating choices leading to excess calorie intake and physical activity patterns leading to diminished calorie expenditure. An imbalance between the two over time leads to increased weight. On a population basis, the prevalence of overweight is associated with a myriad of influences, including social, behavioral, cultural, and environmental factors as well as genetic and physiological factors. For a majority of overweight individuals, restoring a balance between energy intake and expenditure is difficult, and therefore there is an increasing emphasis on preventing obesity on a population level. The long-term goal of this research is to prevent further increase in rates of obesity in the population. In the adult population of working age, a majority of the day is spent in the worksite, suggesting that interventions at the worksite level may offer the opportunity for success in this age group. It is anticipated that this project will yield important contributions to the understanding of obesity prevention.
Detailed description
BACKGROUND:
More than half of American adults are overweight or obese, and this proportion is increasing. The health risks associated with obesity include diabetes, cardiovascular disease, arthritis, and some cancers. It is well established that on an individual level, weight gain is caused by taking in more calories than are expended. On a population basis, the prevalence of overweight and obesity is associated with a myriad of influences, including genetic and physiological factors as well as social, behavioral, cultural, and environmental factors. Behavioral factors that contribute to weight gain include eating choices that lead to increased energy intake and physical activity choices that lead to decreased energy expenditure. For a majority of overweight individuals, restoring the balance between energy intake and expenditure is difficult.
DESIGN NARRATIVE:
This study will develop and test a comprehensive intervention involving simple messages that will integrate changes in dietary intake with changes in energy expenditure, while simultaneously modifying structural and environmental factors to promote social support and opportunities for behavioral change. The study will recruit and randomize 48 worksites to a 2-year intervention in which the following will be carried out: build a physical activity intervention combining increased daily physical activity and regular, structured exercise; build a dietary intervention that will promote lower calorie intake; and increase worksite access to both healthy foods and physical activity. The primary aim is to evaluate the effectiveness of the intervention in reducing or maintaining body mass index in a randomized controlled trial of worksites. The study will compare changes in body mass index in intervention versus control worksites using two cross-sectional surveys at baseline and follow-up. Additional assessments using biomarkers and fitness measures will be performed in a subset of employees. The research team has considerable experience with interventions at the worksite level and substantial expertise in obesity prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Diet, Behavioral: Exercise, Behavioral: EnvironmentComprehensive worksite intervention |
| 2 | Experimental | Behavioral: Diet, Behavioral: Exercise, Behavioral: EnvironmentDelayed intervention control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets specific standard industrial codes
- At least 20% of employees are sedentary
- Willing to provide a list of employees
- Able to achieve at least a 70% response rate to the baseline survey
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DietA dietary intervention that will promote lower calorie intake | Behavioural | 1, 2 |
| ExerciseA physical activity intervention combining increased daily physical activity and regular, structured exercise | Behavioural | 1, 2 |
| EnvironmentIncrease worksite access to both healthy foods and physical activity | Behavioural | 1, 2 |
Primary outcome
Body mass index
Time frame: Measured at Month 24 follow-up visit; adjusted for baseline body mass index
1 secondary outcome
Self-reported dietary and physical activity behaviors
Time frame: Measured at Month 24 follow-up visit
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 23 Aug 2012.
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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 Beresford study chair
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 Diet, Exercise and Environment in people with Obesity and Cardiovascular Diseases, 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 4 inclusion and 0 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 23 Aug 2012. 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?
Body mass index (time frame: Measured at Month 24 follow-up visit; adjusted for baseline body mass index). 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 23 Aug 2012.