Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Study Overview
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Brief Summary
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This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

Detailed Description
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This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population, compare the differences in effectiveness between body constitution classification based management vs usual health management, and explore the influence of different food composition on the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

Official Title
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Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Health Management
* Behavioral: General Management
* Other: Placebo
* Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Social characteristics: 20-55 year old, had lived in a city for more than one year, kept a watchful eye on losing weight or bodybuilding, practitioner engaged in non- sensitive sectors. Physiological characteristics: met the obesity diagnostic criteria suggested by Prevention and control Guidelines for overweight and obesity of Chinese adults in 2006. Subjects with a BMI between 24 to 28 kg/m2 were defined as overweight, while those with a BMI greater than 28kg/m2 were obese. met the constitution classification standards of Traditional Chinese Medicine. According to the constitution questionnaire formulated on the base of the Chinese Medical Association standard Chinese constitution classification and determination (ZYYXH/T157-2009), the subjects were divided into phlegm-damp type, qi deficiency type and phlegm stasis block type. Exclusion Criteria: with the following major organic disease, secondary obesity caused by diseases, none of phlegm-damp type, qi deficiency type or phlegm stasis block type, women who were planning to become pregnant, pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: health management and product<br>We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants. Meanwhile, we use dietary supplement products of SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS® to help balance the constitution of participants. | Behavioral: Health Management<br>* We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants.<br>Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®<br>* We use dietary supplement products to help balance the constitution of participants. Each participant got one of the three dietary supplement products. SCHSANDRA PLUS, INFINITUS® is a health product made of Schisandra, ginseng, Ginseng, Radix and other plant materials which can help enhance the body's antioxidant capacity. YI RUI CAPSULE , INFINITUS® is a health product made of salvia, hawthorn, alisma, perilla oil microcapsules, panax powder, ginkgo biloba and other plant materials which can assist lower the blood lipid level. Gest Aid Plus, INFINITUS® is a health product made of yam, codonopsis, poria, white beans, dried tangerine peel and other plant materials which can help regulate intestinal flora.<br>|
| Experimental: general management and product<br>We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use dietary supplement products of SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS® to help balance the constitution of participants. | Behavioral: General Management<br>* We provide general information about health. Information is provided through telephones and materials.<br>Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®<br>* We use dietary supplement products to help balance the constitution of participants. Each participant got one of the three dietary supplement products. SCHSANDRA PLUS, INFINITUS® is a health product made of Schisandra, ginseng, Ginseng, Radix and other plant materials which can help enhance the body's antioxidant capacity. YI RUI CAPSULE , INFINITUS® is a health product made of salvia, hawthorn, alisma, perilla oil microcapsules, panax powder, ginkgo biloba and other plant materials which can assist lower the blood lipid level. Gest Aid Plus, INFINITUS® is a health product made of yam, codonopsis, poria, white beans, dried tangerine peel and other plant materials which can help regulate intestinal flora.<br>|
| Experimental: health management and placebo<br>We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants. Meanwhile, we use placebo to replace the dietary supplement products. | Behavioral: Health Management<br>* We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants.<br>Other: Placebo<br>* We use placebo to replace the health product.<br>|
| Placebo Comparator: general management and placebo<br>We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products. | Behavioral: General Management<br>* We provide general information about health. Information is provided through telephones and materials.<br>Other: Placebo<br>* We use placebo to replace the health product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | We measure the body mass index to examine the effect of weight loss Content 10% effective loss of weight Less than 15% safe loss of weight Ensure 5% loss of weight,Content 10% effective loss of weight,Less than 15% safe loss of weight | Baseline,1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percentage | We measure the body fat percentage to examine the effect of weight loss on body composition. | Baseline,1year | 
| Fatty liver | We examine if the participants suffer fatty liver using the method of ultrasonic. | Baseline,1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Constitution Classification, Health Management, Obese Population