Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population

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

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Health Management; Dietary supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®; Behavioral: General Management; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 1452
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100191
      • Peking University Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Dietary supplement: 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.
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.	Dietary supplement: 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.; Behavioral: General Management; We provide general information about health. Information is provided through telephones and materials.
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; 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.; Other: Placebo; We use placebo to replace the health product.
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; We provide general information about health. Information is provided through telephones and materials.; Other: Placebo; We use placebo to replace the health product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline,1year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hai-Jun Wang
• Investigators: Principal Investigator: Jun Ma, Peking University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 9, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Body Constitution Classification; Health Management; Obese Population
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: IRB00001052-13086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No