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

NCT02464566 | Unknown

• 1 other identifier: SaudiCHS
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Reduction

  1-12 weeks

Secondary Outcomes (3)

• Waist circumference changes

  1-12 weeks

• Hip circumference changes

  1-12 weeks

• Systolic and Diastolic Blood pressure changes

  1-12 weeks

Study Arms (2)

L Group

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.

Behavioral: Intensive lifestyle intervention; Other: Health Education

C Group

ACTIVE COMPARATOR

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

Other: Health Education

Interventions

Intensive lifestyle intervention BEHAVIORAL

L Group

Health Education OTHER

C Group; L Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saudi Commission for Health Specialties, Saudi Arabia: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06