Overview

This trial is active, not recruiting.

Condition obesity
Treatments intensive lifestyle intervention, health education
Sponsor Saudi Commission for Health Specialties, Saudi Arabia
Start date January 2015
End date June 2015
Trial size 140 participants
Trial identifier NCT02464566, SaudiCHS

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
intensive lifestyle intervention
health education
(Active Comparator)
One session regarding diet restriction and physical activity with printed health education papers.
health education

Primary Outcomes

Measure
Weight Reduction
time frame: 1-12 weeks

Secondary Outcomes

Measure
Waist circumference changes
time frame: 1-12 weeks
Hip circumference changes
time frame: 1-12 weeks
Systolic and Diastolic Blood pressure changes
time frame: 1-12 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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)

Additional Information

Official title 12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Saudi Commission for Health Specialties, Saudi Arabia.