ObesityAWESOMENCT00827424
The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women
A study testing Lifestyle counseling by applying a modified PACE protocol in people with Obesity, run by Clalit Health Services at 1 site in Israel.
Trial summary
Scientific background: Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes. In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times higher than Jewish females, respectively. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle counseling by applying a modified PACE protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Jul 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 35 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Arab women
- Age range 35-64
- Insured by Clalit Health Services (CHS)
- Residence in the target communities
- BMI > 30 kg/m2
- Signed informed consent
Who cannot join
- Failure in any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Israel1 site
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Haifa, 35024
About this study
Official title: The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (The AWESOME Study: Arab WomEn Study on Obesity Metabolism and Exercise)
Scientific background:
Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes. In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times higher than Jewish females, respectively. The economic impact of obesity and overweight in terms of illness, disease and lost productivity is estimated to amount to 2-9% of the national health budget in countries with high GDP. Diabetics have medical expenditure that is 2.4 times higher than non diabetics per capita.
Read more
Lifestyle modification is an effective tool in reducing morbidity and health care expenditure but despite that most family practitioners usually treat the complications of obesity rather than preventing it.
PACE is a comprehensive health promotion guide in counseling patients to an active healthy lifestyle. PACE is designed to assist the primary health care providers to promote physical activity and dietary changes during routine office visits.
Objectives:
To asses the impact of PACE program on increasing the amount of physical activity, improving clinical and metabolic indices, increasing the documentation of lifestyle indices in the medical records and reducing health care expenditure and utilization.
Working hypothesis:
Implementing a modified PACE protocol can achieve this objectives in Arab women.
Methodology:
The investigators will conduct a structured, multidisciplinary and continuous primary care based intervention, assisted by trained health promoters and applying a locally adjusted PACE protocol.
- Conditions
- Obesity
- Being tested
- Lifestyle counseling by applying a modified PACE protocol
- Keywords
- physical activity (PA), obesity, life style modification, physical activity, diet, BMI reduction, clinical and metabolic measure, health expenditure, improvement of patient readiness for lifestyle change
- 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.
Lifestyle counseling by applying a modified PACE protocolBehavioural
Lifestyle counseling by applying a modified PACE protocol to obese Arab women
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This arm will receive Lifestyle counseling by applying a modified PACE protocol Receives: Behavioral: Lifestyle counseling by applying a modified PACE protocol |
| 2 | No intervention | Subject in this arm will be recruited but will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
A significant change in BMI
Measured: every 3 months for 18 month
Secondary outcomes (4)
Patient's lifestyle habits: physical activity, eating habits
Measured: every 3 months for 18 month
Patient's clinical measures: BP, Waist Circumference
Measured: every 3 months for 18 month
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
Measured: every 3 months for 18 month
Patient's readiness for change: Determined by the PACE score
Measured: every 3 months for 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2010
- Study completionJul 2010
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Batya Kornboim, MD, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .Uzi Milman, MD, Principal investigator, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827424
- Sponsor's protocol ID
- CMC-07-0054CTIL
- Acronym
- AWESOME
- Status last verified
- Aug 2010
- First submitted
- 21 Jan 2009
- Last updated
- 24 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the PACE Program Implementation on Health Services Utilization by Obese Arab Women (The AWESOME Study: Arab WomEn Study on Obesity Metabolism and Exercise)
- ClinicalTrials.gov ID
- NCT00827424
- Acronym / sponsor ID
- AWESOME / CMC-07-0054CTIL
- Conditions
- Obesity
- Keywords
- physical activity (PA), obesity, life style modification, physical activity, diet, BMI reduction, clinical and metabolic measure, health expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Jan 2009 (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.
Scientific background:
Obesity is a known risk factor for cardiovascular disease, metabolic syndrome, and diabetes. In Israel, the prevalence of obesity and diabetes among Arab females is 2 and 2.8 times higher than Jewish females, respectively. The economic impact of obesity and overweight in terms of illness, disease and lost productivity is estimated to amount to 2-9% of the national health budget in countries with high GDP. Diabetics have medical expenditure that is 2.4 times higher than non diabetics per capita.
Lifestyle modification is an effective tool in reducing morbidity and health care expenditure but despite that most family practitioners usually treat the complications of obesity rather than preventing it.
PACE is a comprehensive health promotion guide in counseling patients to an active healthy lifestyle. PACE is designed to assist the primary health care providers to promote physical activity and dietary changes during routine office visits.
Objectives:
To asses the impact of PACE program on increasing the amount of physical activity, improving clinical and metabolic indices, increasing the documentation of lifestyle indices in the medical records and reducing health care expenditure and utilization.
Working hypothesis:
Implementing a modified PACE protocol can achieve this objectives in Arab women.
Methodology:
The investigators will conduct a structured, multidisciplinary and continuous primary care based intervention, assisted by trained health promoters and applying a locally adjusted PACE protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle counseling by applying a modified PACE protocolThis arm will receive Lifestyle counseling by applying a modified PACE protocol |
| 2 | No intervention | –Subject in this arm will be recruited but will receive no intervention |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Arab women
- Age range 35-64
- Insured by Clalit Health Services (CHS)
- Residence in the target communities
- BMI > 30 kg/m2
Key exclusion criteria (1 listed)
- Failure in any of the inclusion criteria
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 |
|---|---|---|
| Lifestyle counseling by applying a modified PACE protocolLifestyle counseling by applying a modified PACE protocol to obese Arab women | Behavioural | 1 |
Primary outcome
A significant change in BMI
Time frame: every 3 months for 18 month
4 secondary outcomes
Patient's lifestyle habits: physical activity, eating habits
Time frame: every 3 months for 18 month
Patient's clinical measures: BP, Waist Circumference
Time frame: every 3 months for 18 month
Patient's metabolic measure: HbA1c, lipid profile, fasting plasma glucose (FPG)
Time frame: every 3 months for 18 month
Patient's readiness for change: Determined by the PACE score
Time frame: every 3 months for 18 month
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 24 Aug 2010.
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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.
Batya Kornboim, MD principal investigator
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
Uzi Milman, MD principal investigator
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District .
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling by applying a modified PACE protocol in people with Obesity, run by Clalit Health Services at 1 site in Israel.
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 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 24 Aug 2010. 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 Israel. 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?
A significant change in BMI (time frame: every 3 months for 18 month). 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 24 Aug 2010.