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CompletedNCT02298426Updated Apr 6, 2017

Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

An interventional study of Health Management and General Management in Overweight and Obesity, sponsored by Hai-Jun Wang. Completed at 1 site in China. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-04-06.

Sponsored by Hai-Jun Wang · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,452
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Overweight
  • Obesity

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Keywords

  • Body Constitution Classification
  • Health Management
  • Obese Population
03

In context

Overweight

3,671 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 1,452 is above the median of 74 across 3,176 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Hai-Jun Wang is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
1,452 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Health Management · Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®

  • Experimental
    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.

    Behavioral: General Management · Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®

  • Experimental
    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.

    Behavioral: Health Management · Other: Placebo

  • Placebo comparator
    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.

    Behavioral: General Management · Other: Placebo

Interventions

  • BehavioralHealth 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.

  • BehavioralGeneral Management

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

  • OtherPlacebo

    We use placebo to replace the health product.

  • Dietary supplementSCHSANDRA 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.

06

What researchers measure

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

    Time frame: Baseline,1year

Secondary outcomes

  1. Body fat percentage

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

    Time frame: Baseline,1year

  2. Fatty liver

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

    Time frame: Baseline,1year

07

Study locations

1 site
  • Peking University Health Science Center
    Peking, Beijing 100191, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02298426
Lead sponsor
Hai-Jun Wang
Responsible party
Hai-Jun Wang (professor, Peking University) — Sponsor-investigator
First posted
Nov 24, 2014
Start date
Apr 2014
Primary completion
May 2015
Completion
Oct 2015
Last update
Apr 6, 2017

Study contacts

Jun Ma
principal investigator · Peking University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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