Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Hai-Jun Wang

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: General Management; Other: Placebo; Behavioral: Health Management; Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®

Study type: Interventional

Funder types: Other

Identifiers

NCT02298426

IRB00001052-13086

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,452 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,452 participants in 4 patient groups, including a placebo group

health management and product

Experimental group

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.

Treatment:

Behavioral: Health Management

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

general management and product

Experimental group

Description:

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.

Treatment:

Behavioral: General Management

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

health management and placebo

Experimental group

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.

Treatment:

Behavioral: Health Management

Other: Placebo

general management and placebo

Placebo Comparator group

Description:

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

Treatment:

Behavioral: General Management

Other: Placebo