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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive lifestyle intervention
Health Education
Sponsored by
Saudi Commission for Health Specialties, Saudi Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    L Group

    C Group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Weight Reduction

    Secondary Outcome Measures

    Waist circumference changes
    Hip circumference changes
    Systolic and Diastolic Blood pressure changes

    Full Information

    First Posted
    June 1, 2015
    Last Updated
    June 3, 2015
    Sponsor
    Saudi Commission for Health Specialties, Saudi Arabia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02464566
    Brief Title
    12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015
    Official Title
    12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    June 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Saudi Commission for Health Specialties, Saudi Arabia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    L Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    C Group
    Arm Type
    Active Comparator
    Arm Description
    One session regarding diet restriction and physical activity with printed health education papers.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Intensive lifestyle intervention
    Intervention Type
    Other
    Intervention Name(s)
    Health Education
    Primary Outcome Measure Information:
    Title
    Weight Reduction
    Time Frame
    1-12 weeks
    Secondary Outcome Measure Information:
    Title
    Waist circumference changes
    Time Frame
    1-12 weeks
    Title
    Hip circumference changes
    Time Frame
    1-12 weeks
    Title
    Systolic and Diastolic Blood pressure changes
    Time Frame
    1-12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

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