Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Behavioral: General Management; Behavioral: Health Management; Other: Placebo

• Registration Number: NCT02298426
• Lead Sponsor: Hai-Jun Wang

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-09
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-24
• Primary Completion: 2015-05
• Study Completion: 2015-10
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1452

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
health management and placebo	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.
general management and placebo	General Management	We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products.
general management and placebo	Placebo	We provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products.
general management and product	General Management	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.
health management and placebo	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. Meanwhile, we use placebo to replace the dietary supplement products.
health management and product	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. Meanwhile, we use dietary supplement products of "SCHSANDRA PLUS", "YI RUI CAPSULE", "Gest Aid Plus": "INFINITUS®" to help balance the constitution of participants.

Primary Outcome Measures

Name	Time	Method
BMI	Baseline,1year	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

Name	Time	Method
Body fat percentage	Baseline,1year	We measure the body fat percentage to examine the effect of weight loss on body composition.
Fatty liver	Baseline,1year	We examine if the participants suffer fatty liver using the method of ultrasonic.

Trial Locations

Locations (1)

Peking University Health Science Center; 🇨🇳 Peking, Beijing, China