OverweightNCT02298426
Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
A study testing Health Management, General Management and SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS® in people with Overweight and Obesity, run by Hai-Jun Wang at 1 site in China.
Trial summary
This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Health Management, General Management and SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,452 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking University Health Science Center
Beijing, Beijing Municipality, 100191
About this study
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.
- Conditions
- Overweight, Obesity
- Being tested
- Health Management, General Management, Placebo, SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®
- Keywords
- Body Constitution Classification, Health Management, Obese Population
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health ManagementBehavioural
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 ManagementBehavioural
We provide general information about health. Information is provided through telephones and materials.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| health management and product | Experimental | 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. Receives: Behavioral: Health Management; Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS® |
| general management and product | Experimental | 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. Receives: Behavioral: General Management; Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS® |
| health management and placebo | Experimental | 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. Receives: Behavioral: Health Management; Other: Placebo |
| general management and placebo | Placebo comparator | We provide general information about health. Information is provided through telephones and materials.
Meanwhile, we use placebo to replace the dietary supplement products. Receives: Behavioral: General Management; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline,1year
Secondary outcomes (2)
Body fat percentage
We measure the body fat percentage to examine the effect of weight loss on body composition.
Measured: Baseline,1year
Fatty liver
We examine if the participants suffer fatty liver using the method of ultrasonic.
Measured: Baseline,1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hai-Jun Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hai-Jun Wang, Peking University
- Investigators
- Jun Ma, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298426
- Sponsor's protocol ID
- IRB00001052-13086
- Status last verified
- Apr 2017
- First submitted
- 9 Nov 2014
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
- ClinicalTrials.gov ID
- NCT02298426
- Acronym / sponsor ID
- IRB00001052-13086
- Conditions
- Overweight, Obesity
- Keywords
- Body Constitution Classification, Health Management, Obese Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,452 participants (actual)
- Lead sponsor
- Hai-Jun WangUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| health management and product | Experimental | Behavioral: Health Management, Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®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. |
| general management and product | Experimental | Behavioral: General Management, Dietary Supplement: SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®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 | Experimental | Behavioral: Health Management, Other: PlaceboWe 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 | Placebo comparator | Behavioral: General Management, Other: PlaceboWe provide general information about health. Information is provided through telephones and materials. Meanwhile, we use placebo to replace the dietary supplement products. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Social characteristics:
- Physiological characteristics:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health ManagementWe 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. | Behavioural | health management and placebo, health management and product |
| General ManagementWe provide general information about health. Information is provided through telephones and materials. | Behavioural | general management and placebo, general management and product |
| PlaceboWe use placebo to replace the health product. | Other | general management and placebo, health management and placebo |
| 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. | Dietary supplement | general management and product, health management and product |
Primary outcome
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
2 secondary outcomes
Body fat percentage
Time frame: Baseline,1year
Fatty liver
Time frame: Baseline,1year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Management, General Management and SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS® in people with Overweight and Obesity, run by Hai-Jun Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: Baseline,1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.