Metabolic SyndromeNCT00273572
Lifestyle Intervention in Obese Arab Women
A study testing Moderate Lifestyle Intervention and Intensive lifestyle intervention in people with Metabolic Syndrome and Diabetes, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women Read more about this study
- Who is it for?
- Ages 35 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes
- What is being tested?
- Moderate Lifestyle Intervention and Intensive lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2004to Jul 2008
- 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 54 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obesity (BMI: 30-40 kg/squared meter)
- Female Gender
- Being 35-54 years old
Who cannot join
- Diabetic
- A contraindication for physical activity
Trial locations and contacts
1 site in 1 country.
Israel1 site
Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center
Tel-Hashomer, Ramat-Gan, 52621
About this study
Official title: The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women
Read the detailed description
200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.
- Conditions
- Metabolic Syndrome, Diabetes
- Being tested
- Moderate Lifestyle Intervention, Intensive lifestyle intervention
- Keywords
- Obesity, Women, Arab, Metabolic syndrome, Lifestyle intervention, Quality of life
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Lifestyle InterventionOther
Also called Lifestyle intervention
Two educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up
Intensive lifestyle interventionOther
Also called Lifestyle intervention
A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor
| Study group | Role | What they receive |
|---|---|---|
| Moderate lifestyle intervention | Active comparator | Moderate lifestyle intervention including two group sessions and one individual counselling session with a nutritionist, at recruitment. Individual sessions with a nutritionist after 6 and 12 months on follow-up. Receives: Other: Moderate Lifestyle Intervention |
| Intensive lifestyle intervention | Experimental | Intensive lifestyle intervention, including bi-monthly group sessions with a physical activity instructor; a monthly group session with a nutritionist, and a monthly individual session with a nutritionist. Receives: Other: Intensive lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of the metabolic syndrome
Measured: At baseline, and after 6 and 12 months
Secondary outcomes (2)
Quality of life
Measured: At baseline, and after 12 months
Attainment of weight reduction and physical activity targets
Measured: At baseline, and after 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 posted9 Jan 2006 (estimated)
- Study startDec 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- D-Cure, Israel, Chief Scientist, The Israel Ministry of Science
- Investigators
- Ofra Kalter - Leibovici, M.D., Principal investigator, Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273572
- Sponsor's protocol ID
- SHEBA-04-3335-OK-CTIL
- Status last verified
- Oct 2008
- First submitted
- 5 Jan 2006
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalter-Leibovici O, Younis-Zeidan N, Atamna A, Lubin F, Alpert G, Chetrit A, Novikov I, Daoud N, Freedman LS. Lifestyle intervention in obese Arab women: a randomized controlled trial. Arch Intern Med. 2010 Jun 14;170(11):970-6. doi: 10.1001/archinternmed.2010.103.
PubMed 20548010
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women
- ClinicalTrials.gov ID
- NCT00273572
- Acronym / sponsor ID
- SHEBA-04-3335-OK-CTIL
- Conditions
- Metabolic Syndrome, Diabetes
- Keywords
- Obesity, Women, Arab, Metabolic syndrome, Lifestyle intervention, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- D-Cure, Israel, Chief Scientist, The Israel Ministry of Science
- Study start
- Dec 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Jan 2006 (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 study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women
Detailed description
200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate lifestyle intervention | Active comparator | Other: Moderate Lifestyle InterventionModerate lifestyle intervention including two group sessions and one individual counselling session with a nutritionist, at recruitment. Individual sessions with a nutritionist after 6 and 12 months on follow-up. |
| Intensive lifestyle intervention | Experimental | Other: Intensive lifestyle interventionIntensive lifestyle intervention, including bi-monthly group sessions with a physical activity instructor; a monthly group session with a nutritionist, and a monthly individual session with a nutritionist. |
Who may qualify
- Ages
- 35 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obesity (BMI: 30-40 kg/squared meter)
- Female Gender
- Being 35-54 years old
Key exclusion criteria (2 listed)
- Diabetic
- A contraindication for physical activity
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 |
|---|---|---|
| Moderate Lifestyle InterventionAlso: Lifestyle interventionTwo educational group meetings with a dietitian in the first month of intervention; One individual counselling session with a dietitian at baseline, and at 6-month and 12-month follow-up | Other | Moderate lifestyle intervention |
| Intensive lifestyle interventionAlso: Lifestyle interventionA monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor | Other | Intensive lifestyle intervention |
Primary outcome
Parameters of the metabolic syndrome
Time frame: At baseline, and after 6 and 12 months
2 secondary outcomes
Quality of life
Time frame: At baseline, and after 12 months
Attainment of weight reduction and physical activity targets
Time frame: At baseline, and after 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 29 Oct 2008.
- Derived from this study: PubMed 20548010Kalter-Leibovici O, Younis-Zeidan N, Atamna A, Lubin F, Alpert G, Chetrit A, Novikov I, Daoud N, Freedman LS. Lifestyle intervention in obese Arab women: a randomized controlled trial. Arch Intern Med. 2010 Jun 14;170(11):970-6. doi: 10.1001/archinternmed.2010.103.
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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.
Ofra Kalter - Leibovici, M.D. principal investigator
Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Lifestyle Intervention and Intensive lifestyle intervention in people with Metabolic Syndrome and Diabetes, run by Sheba Medical Center 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 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 29 Oct 2008. 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?
Parameters of the metabolic syndrome (time frame: At baseline, and after 6 and 12 months). 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 NCT00273572, which also lists 1 linked publication.
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 29 Oct 2008.