12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015

NCT ID: NCT02464566

Last Updated: 2015-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-06-30

Brief Summary

With low carbohydrate dietary approach for both arms, the investigators will examine the effectiveness of 12-weeks intensive lifestyle intervention program provided in individual sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of baseline weight for experimental participants in comparison with active comparator group (only one health education session).

Detailed Description

The study has two arms:

Active Comparator Arm:

Only health education. One session regarding diet restriction and physical activity with printed health education papers.

Experimental Arm:

Intensive lifestyle intervention Weekly individual session in obesity clinic (15 to 20 min.) for the first 4 weeks then one individual session in obesity clinic (10 to 20 min.) every two weeks (week 5 to week 12).

Total sessions in 12 weeks: 8 (including the final data collection visit).The components of the program: 1) Low carbohydrate (aim to achieve spontaneous reduction in calorie intake) 2) increased physical activity; 3) behavioral strategies to facilitate adherence to diet and activity prescriptions.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L Group

Weekly individual session in obesity clinic (15 to 20 min.) for the first 4 weeks then one individual session in obesity clinic (10 to 20 min.) every two weeks (week 5 to week 12).

Total sessions in 12 weeks: 8 (including the final data collection visit). The components of the program:

1) Low carbohydrate (aim to achieve spontaneous reduction in calorie intake) 2) increased physical activity; 3) behavioural strategies to facilitate adherence to diet and activity prescriptions.

Group Type: EXPERIMENTAL

Intensive lifestyle intervention

Intervention Type: BEHAVIORAL

Health Education

Intervention Type: OTHER

C Group

One session regarding diet restriction and physical activity with printed health education papers.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: OTHER

Interventions

Intensive lifestyle intervention

Intervention Type: BEHAVIORAL

Health Education

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 20 years old or older
• Arabic Male or female
• Body mass index in kg/m2 (BMI) ≥30

Exclusion Criteria

• Had recent weight loss equal or more than 5% of baseline weight
• Currently take weight loss medication or enrolled in another weight loss program
• Undergone or scheduled (within study duration) weight loss surgery
• History of diabetes, thyroid dysfunction or any other endocrine abnormality, gout, coronary heart disease, stroke, malignancy or psychological condition
• Medical condition that limits ability to comply with the program's physical activity recommendations
• Pregnant or lactating women
• If one participant had recruited in the study, his family members who live with him in the same home will be ineligible (to avoid contamination from the ripple effect on weight loss)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saudi Commission for Health Specialties, Saudi Arabia

OTHER_GOV

Sponsor Role: lead

Responsible Party

Riyad Q. Alghamdi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SaudiCHS

Identifier Type: -

Identifier Source: org_study_id