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Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Health Management

General Management

Placebo

SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®

About this trial

This is an interventional prevention trial for Overweight focused on measuring Body Constitution Classification, Health Management, Obese Population

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

health management and product

general management and product

health management and placebo

general management and placebo

Arm Description

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.

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.

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.

We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Body fat percentage

We measure the body fat percentage to examine the effect of weight loss on body composition.

Fatty liver

We examine if the participants suffer fatty liver using the method of ultrasonic.

Full Information

NCT ID

NCT02298426

First Posted

November 9, 2014

Last Updated

April 4, 2017

Sponsor

Hai-Jun Wang

1. Study Identification

Unique Protocol Identification Number

NCT02298426

Brief Title

Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Official Title

Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hai-Jun Wang

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

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

Overweight, Obesity

Keywords

Body Constitution Classification, Health Management, Obese Population

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

1452 (Actual)

8. Arms, Groups, and Interventions

Arm Title

health management and product

Arm Type

Experimental

Arm Description

Arm Title

general management and product

Arm Type

Experimental

Arm Description

Arm Title

health management and placebo

Arm Type

Experimental

Arm Description

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.

Arm Title

general management and placebo

Arm Type

Placebo Comparator

Arm Description

We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products.

Intervention Type

Behavioral

Intervention Name(s)

Health Management

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

General Management

Intervention Description

We provide general information about health. Information is provided through telephones and materials.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

We use placebo to replace the health product.

Intervention Type

Dietary Supplement

Intervention Name(s)

SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®

Intervention Description

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.

Primary Outcome Measure Information:

Title

BMI

Description

Time Frame

Baseline,1year

Secondary Outcome Measure Information:

Title

Body fat percentage

Description

We measure the body fat percentage to examine the effect of weight loss on body composition.

Time Frame

Baseline,1year

Title

Fatty liver

Description

We examine if the participants suffer fatty liver using the method of ultrasonic.

Time Frame

Baseline,1year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Ma

Organizational Affiliation

Peking University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Health Science Center

City

Peking

State/Province

Beijing

ZIP/Postal Code

100191

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

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