Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 2:07 PM
Study NCT ID:
NCT02464566
Status:
UNKNOWN
Last Update Posted:
2015-06-08
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015
Sponsor:
Saudi Commission for Health Specialties, Saudi Arabia
Organization:
Study Overview
Official Title:
12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: