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Completed

NCT Number: NCT02298426

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Health Science Center

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Management

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.

General Management

Behavioral

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

Placebo

Other

We use placebo to replace the health product.

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

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.

Primary outcomes

  1. BMI

    Time frame: 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 outcomes

  1. Body fat percentage

    Time frame: Baseline,1year

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

  2. Fatty liver

    Time frame: Baseline,1year

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

Sponsors and collaborators

Lead sponsor

Hai-Jun Wang

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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