ObesityNCT02509741
Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
A study testing Education, Food replacement and IOT monitoring in people with Obesity, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
This research is aimed at verifying the effects of diets with high protein and low glycemic index (GI) on weight management among overweight or obese Chinese adult. Additionally, the investigators intend to verify the effects of two new approaches, including food replacement and Internet-of-things (IOT) monitoring on… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Education, Food replacement and IOT monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2015to Dec 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health adult, age:18-65，BMI（kg/m2）:27.0-40.0
Who cannot join
- Patients under regular medical treatment for chronic diseases like diabetes, hypertension, gout and hyperuricemia.
- The patients with chronic renal diseases or other diseases which impose restrictions on the intake of proteins.
- Mental patients.
- People who suffer from secondary obesity caused by endocrine, metabolic disorders or some central nervous system diseases.
- People who are under medical or surgical weight-loss treatments in the past three months.
- People whose weight fluctuations are not less than 5kg in the past two months；
Show all 10Show fewer
- People with food allergies.
- Men or women who drink regularly over 25g or 15 g daily,respectively.
- Pregnant women and women who prepare to be pregnant.
- Lactating women
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 410013
Xiaolan Zhao, +86-23-68754919, zhaoxiaolan65@126.com
- Recruiting
Hangzhou PLA sanatorium
Hangzhou, Zhejiang, 310000
Zili Zhong, +86-0571-87127082, zhongzili@nutriease.com
About this study
This research is aimed at verifying the effects of diets with high protein and low glycemic index (GI) on weight management among overweight or obese Chinese adult. Additionally, the investigators intend to verify the effects of two new approaches, including food replacement and Internet-of-things (IOT) monitoring on weight control.
- Conditions
- Obesity
- Being tested
- Education, Food replacement, IOT monitoring
- Keywords
- obesity, nutrition, intervention, food replacement, IOT
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Food replacementDietary supplement
IOT monitoringBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | High-protein and low-GI diet education Receives: Behavioral: Education |
| Dietary intervention | Experimental | High-protein and low-GI diet plus education Receives: Behavioral: Education; Dietary Supplement: Food replacement |
| Internet-of-things (IOT) monitoring intervention | Experimental | Dietary intervention plus IOT monitoring Receives: Behavioral: Education; Dietary Supplement: Food replacement; Behavioral: IOT monitoring |
| control | No intervention | Routine diet recommendation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite changes of weight, waist circumference and BMI
the measure is a composite
Measured: 3~5 years
Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan
Measured: 3~5 years
Dropout ratio during weight-loss period and maintenance period
Measured: 3~5 years
Secondary outcomes (3)
Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids
Measured: 3~5 years
Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators
Measured: 3~5 years
Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects
Measured: 3~5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zeng, Chinese PLA General Hospital
- Investigators
- Qiang Zeng, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509741
- Sponsor's protocol ID
- CHPF2012014
- Status last verified
- Oct 2017
- First submitted
- 15 Jul 2015
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China
- ClinicalTrials.gov ID
- NCT02509741
- Acronym / sponsor ID
- CHPF2012014
- Conditions
- Obesity
- Keywords
- obesity, nutrition, intervention, food replacement, IOT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 28 Jul 2015 (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 research is aimed at verifying the effects of diets with high protein and low glycemic index (GI) on weight management among overweight or obese Chinese adult. Additionally, the investigators intend to verify the effects of two new approaches, including food replacement and Internet-of-things (IOT) monitoring on weight control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Behavioral: EducationHigh-protein and low-GI diet education |
| Dietary intervention | Experimental | Behavioral: Education, Dietary Supplement: Food replacementHigh-protein and low-GI diet plus education |
| Internet-of-things (IOT) monitoring intervention | Experimental | Behavioral: Education, Dietary Supplement: Food replacement, Behavioral: IOT monitoringDietary intervention plus IOT monitoring |
| control | No intervention | –Routine diet recommendation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health adult, age:18-65，BMI（kg/m2）:27.0-40.0
Key exclusion criteria (10 listed)
- Patients under regular medical treatment for chronic diseases like diabetes, hypertension, gout and hyperuricemia.
- The patients with chronic renal diseases or other diseases which impose restrictions on the intake of proteins.
- Mental patients.
- People who suffer from secondary obesity caused by endocrine, metabolic disorders or some central nervous system diseases.
- People who are under medical or surgical weight-loss treatments in the past three months.
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 |
|---|---|---|
| Education | Behavioural | Dietary intervention, Educational intervention, Internet-of-things (IOT) monitoring intervention |
| Food replacement | Dietary supplement | Dietary intervention, Internet-of-things (IOT) monitoring intervention |
| IOT monitoring | Behavioural | Internet-of-things (IOT) monitoring intervention |
Primary outcome
Composite changes of weight, waist circumference and BMI
Time frame: 3~5 years
the measure is a composite
Body composition change is measured by means of Bioelectrical Impedance Analysis (BIA) and CT scan
Time frame: 3~5 years
Dropout ratio during weight-loss period and maintenance period
Time frame: 3~5 years
3 secondary outcomes
Composite changes in cardiovascular health indicators such as blood pressure, blood glucose, and blood lipids
Time frame: 3~5 years
Composite changes in inflammatory markers, diet and physical activity level, Leptin and adiponectin, compliance of weight-loss and other indicators
Time frame: 3~5 years
Composite changes in diet-related behaviors such as satiety, food preferences, social support, appetite, healthy lifestyle and psychological aspects
Time frame: 3~5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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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.
Qiang Zeng, MD principal investigator
Chinese PLA General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Food replacement and IOT monitoring in people with Obesity, run by Chinese PLA General Hospital at 2 sites 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan He, MD (+86-10-62115671, heyuan8506@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite changes of weight, waist circumference and BMI (time frame: 3~5 years). The study lists 3 primary outcomes in all. 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 1 Nov 2017.