Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
1 other identifier
interventional
1,452
1 country
1
Brief Summary
This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 9, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedApril 6, 2017
April 1, 2017
1.1 years
November 9, 2014
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Body fat percentage
Baseline,1year
Fatty liver
Baseline,1year
Study Arms (4)
health management and product
EXPERIMENTALWe 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.
general management and product
EXPERIMENTALWe 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.
health management and placebo
EXPERIMENTALWe 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.
general management and placebo
PLACEBO COMPARATORWe provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products.
Interventions
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.
We provide general information about health. Information is provided through telephones and materials.
We use placebo to replace the health product.
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.
Eligibility Criteria
You may qualify if:
- Social characteristics:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hai-Jun Wanglead
Study Sites (1)
Peking University Health Science Center
Beijing, Beijing Municipality, 100191, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Ma
Peking University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
November 9, 2014
First Posted
November 24, 2014
Study Start
April 1, 2014
Primary Completion
May 1, 2015
Study Completion
October 1, 2015
Last Updated
April 6, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share