Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

NCT ID: NCT02298426

Last Updated: 2017-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

health management and product

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.

Group Type EXPERIMENTAL

Health Management

Intervention Type BEHAVIORAL

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.

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

Intervention Type DIETARY_SUPPLEMENT

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.

general management and product

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.

Group Type EXPERIMENTAL

General Management

Intervention Type BEHAVIORAL

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

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

Intervention Type DIETARY_SUPPLEMENT

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.

health management and placebo

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.

Group Type EXPERIMENTAL

Health Management

Intervention Type BEHAVIORAL

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.

Placebo

Intervention Type OTHER

We use placebo to replace the health product.

general management and placebo

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

Meanwhile, we use placebo to replace the dietary supplement products.

Group Type PLACEBO_COMPARATOR

General Management

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type OTHER

We use placebo to replace the health product.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

General Management

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

Intervention Type BEHAVIORAL

Placebo

We use placebo to replace the health product.

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hai-Jun Wang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hai-Jun Wang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jun Ma

Role: PRINCIPAL_INVESTIGATOR

Peking University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Health Science Center

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB00001052-13086

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Observation on Obesity Undergoing XOWI
NCT05122936 ENROLLING_BY_INVITATION
Whole Body Vibration After Bariatric Surgery
NCT05695599 ACTIVE_NOT_RECRUITING NA
SH Dr. Chen Gastric Bypass Study
NCT05357443 ACTIVE_NOT_RECRUITING NA