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

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ClinicalTrials.gov Identifier: NCT02464566
Recruitment Status : Unknown
Verified June 2015 by Riyad Q. Alghamdi, Saudi Commission for Health Specialties, Saudi Arabia.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Riyad Q. Alghamdi, Saudi Commission for Health Specialties, Saudi Arabia

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).

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intensive lifestyle intervention Other: Health Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015
Study Start Date : January 2015
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: 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.

Behavioral: Intensive lifestyle intervention
Other: Health Education
Active Comparator: C Group
One session regarding diet restriction and physical activity with printed health education papers.
Other: Health Education



Primary Outcome Measures :
  1. Weight Reduction [ Time Frame: 1-12 weeks ]

Secondary Outcome Measures :
  1. Waist circumference changes [ Time Frame: 1-12 weeks ]
  2. Hip circumference changes [ Time Frame: 1-12 weeks ]
  3. Systolic and Diastolic Blood pressure changes [ Time Frame: 1-12 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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Responsible Party: Riyad Q. Alghamdi, Dr., Saudi Commission for Health Specialties, Saudi Arabia
ClinicalTrials.gov Identifier: NCT02464566     History of Changes
Other Study ID Numbers: SaudiCHS
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms