Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Obesity Clinical Trial

Official title:

Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298426
• Other study ID #: IRB00001052-13086
• Status: Completed
• Phase: N/A
• First received: November 9, 2014
• Last updated: April 4, 2017
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2017
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1452
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Health Management
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.
• General Management
We provide general information about health. Information is provided through telephones and materials.

Other:
• Placebo
We use placebo to replace the health product.

Dietary Supplement:
• SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®
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.

Locations

Country	Name	City	State
China	Peking University Health Science Center	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hai-Jun Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body fat percentage	We measure the body fat percentage to examine the effect of weight loss on body composition.	Baseline,1year
Secondary	Fatty liver	We examine if the participants suffer fatty liver using the method of ultrasonic.	Baseline,1year