12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 主要终点
- Weight Reduction
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years old or older
- •Arabic Male or female
- •Body mass index in kg/m2 (BMI) ≥30
排除标准
- •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)
研究组 & 干预措施
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:
- 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.
干预措施: Intensive lifestyle intervention (Behavioral)
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:
- 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.
干预措施: Health Education (Other)
C Group
One session regarding diet restriction and physical activity with printed health education papers.
干预措施: Health Education (Other)
结局指标
主要结局
Weight Reduction
时间窗: 1-12 weeks
次要结局
- Waist circumference changes(1-12 weeks)
- Hip circumference changes(1-12 weeks)
- Systolic and Diastolic Blood pressure changes(1-12 weeks)
研究者
Riyad Q. Alghamdi
Dr.
Saudi Commission for Health Specialties, Saudi Arabia