NCT00273572

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

3.6 years

First QC Date

January 5, 2006

Last Update Submit

October 27, 2008

Conditions

Metabolic SyndromeDiabetes

Keywords

ObesityWomenArabMetabolic syndromeLifestyle interventionQuality of life

Outcome Measures

Primary Outcomes (1)

  • Parameters of the metabolic syndrome

    At baseline, and after 6 and 12 months

Secondary Outcomes (2)

  • Quality of life

    At baseline, and after 12 months

  • Attainment of weight reduction and physical activity targets

    At baseline, and after 6 and 12 months

Study Arms (2)

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.

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.

Other: Intensive lifestyle intervention

Interventions

Moderate Lifestyle InterventionOTHER

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

Also known as: Lifestyle intervention
Moderate lifestyle intervention
Intensive lifestyle interventionOTHER

A monthly individual counselling session with a dietitian; A monthly group session with a dietitian; Bi-monthly group sessions with a physical activity instructor

Also known as: Lifestyle intervention
Intensive lifestyle intervention

Eligibility Criteria

Age35 Years - 54 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obesity (BMI: 30-40 kg/squared meter)
  • Female Gender
  • Being 35-54 years old

You may not qualify if:

  • Diabetic
  • A contraindication for physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center

Tel-Hashomer, Ramat-Gan, 52621, Israel

Location

Related Publications (1)

  • 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.

    PMID: 20548010DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ofra Kalter - Leibovici, M.D.

    Director, Unit of Cardiovascular Epidemiology, Gertner Institute for Epidemiology & Health Policy Research, Sheba Medical Center, ISRAEL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

December 1, 2004

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

IL(1)