Metabolic SyndromeNCT01804504

Nutrition Education on the Metabolic Syndrome of Subjects Who Are Frequently Eating Out

A study testing Nutrition education in people with Metabolic Syndrome, run by Second Military Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The project is aimed at investigating the effect of nutrition education on knowledge, attitude and practice (KAP)of subjects who are frequently eating out, and the effect on metabolic parameters. Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Nutrition education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 1 siteChina
Study dates: Mar 2013to Oct 2013
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 30 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Shanghai urban citizens
Male or female 18 to 25 years of age;
Frequently eat out(eat out 3 or more times per week);
Clinical diagnosis of Metabolic Syndrome(Meet 3 or more Diagnostic criteria); A. Abdominal obesity: waist circumference>90cm ( M ), and>85cm( F ); B. Dyslipidemia:triglyceride≥1.7mmol/L; C. HDL-C < 1.04mmol/L; D. hypertension: blood pressure≥ 130/85mm Hg ( or have been diagnosed hypertension); E. Hyperglycemia : FPG≥6.1mmol/L and ( or ) 2-hour postprandial blood glucose≥7.8mmol/L and ( or ) have been diagnosed with diabetes;
Signed written informed consent ;
Can attend lectures.

Who cannot join

Pregnant woman;
Temporary resident population;
Participating in another clinical trial 6 months before randomization.

Trial locations and contacts

1 site in 1 country.

China1 site

Changhai Hospital,Second Military Medical University
Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: Survey on Eating Out Behavior and Dietary Structure in Urban Chinese Citizens and the Effect of Nutrition Education

The project is aimed at investigating the effect of nutrition education on knowledge, attitude and practice (KAP)of subjects who are frequently eating out, and the effect on metabolic parameters.

Read the detailed description

The project is aimed at investigating the dietary structure and frequencies of eating out via a cross-sectional study, on the basis of which a randomized, parallel controlled trials is to be carried out.The purpose is to evaluate the effect on metabolic parameters.

Hypotheses to be tested:Nutrition education has the effect of improving the metabolic parameters of subjects who are frequently eating out.

Conditions: Metabolic Syndrome
Being tested: Nutrition education
Keywords: Metabolic syndrome, Eating out of home, Nutrition education
Medical subject headings: Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nutrition educationBehavioural
The intervention group will be sent out a series of education materials, be arranged to attend lectures(once a month), dietary guidance or nutrition consultation at regular intervals(once every 2 weeks).

Study groups in NCT01804504
Study group	Role	What they receive
Control	No intervention	Food Frequency Questionnaire(FFQ) and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores. Physical examination and biochemical examination before and after the trial.
Nutrition education	Experimental	FFQ and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores. Physical examination and biochemical examination before and after the trial. Do nutrition education Receives: Behavioral: Nutrition education

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Body Weight
Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.
Measured: Baseline and 24 weeks

Secondary outcomes (4)

Change in Blood pressure
Measured: Baseline and 24 weeks
Change in waist circumference, waist hip ratio, waist to height
Waist, hip circumference and height was measured using a plastic tape to the nearest 0.1 cm
Measured: Baseline and 24 weeks
Change in Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm Change in fasting blood glucose
Measured: Baseline and 24 weeks
Change in serum triglyceride, cholesterol, HDL, LDL
Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Oct 2013

First posted5 Mar 2013 (estimated)
Study startMar 2013
Primary completionSep 2013 (estimated)
Study completionOct 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 78 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01804504
Sponsor's protocol ID: 5186272761903
Status last verified: Mar 2013
First submitted: 25 Feb 2013
Last updated: 6 Mar 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survey on Eating Out Behavior and Dietary Structure in Urban Chinese Citizens and the Effect of Nutrition Education
ClinicalTrials.gov ID: NCT01804504
Acronym / sponsor ID: 5186272761903
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome, Eating out of home, Nutrition education
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 78 participants (estimated)
Lead sponsor: Second Military Medical UniversityUniversity, hospital or other
Study start: Mar 2013
Primary completion: Sep 2013 (estimated)
Study completion: Oct 2013 (estimated)
First posted: 5 Mar 2013 (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.

The project is aimed at investigating the effect of nutrition education on knowledge, attitude and practice (KAP)of subjects who are frequently eating out, and the effect on metabolic parameters.

Detailed description

Hypotheses to be tested:Nutrition education has the effect of improving the metabolic parameters of subjects who are frequently eating out.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Food Frequency Questionnaire(FFQ) and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores. Physical examination and biochemical examination before and after the trial.
Nutrition education	Experimental	Behavioral: Nutrition educationFFQ and KAP Questionnaire will be carried out before and after the trial to evaluate changes in calorie and nutrients intake, dietary structure, and KAP scores. Physical examination and biochemical examination before and after the trial. Do nutrition education

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Shanghai urban citizens
Male or female 18 to 25 years of age;
Frequently eat out(eat out 3 or more times per week);
Clinical diagnosis of Metabolic Syndrome(Meet 3 or more Diagnostic criteria); A. Abdominal obesity: waist circumference>90cm ( M ), and>85cm( F ); B. Dyslipidemia:triglyceride≥1.7mmol/L; C. HDL-C < 1.04mmol/L; D. hypertension: blood pressure≥ 130/85mm Hg ( or have been diagnosed hypertension); E. Hyperglycemia : FPG≥6.1mmol/L and ( or ) 2-hour postprandial blood glucose≥7.8mmol/L and ( or ) have been diagnosed with diabetes;
Signed written informed consent ;

Key exclusion criteria (3 listed)

Pregnant woman;
Temporary resident population;
Participating in another clinical trial 6 months before randomization.

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
Nutrition educationThe intervention group will be sent out a series of education materials, be arranged to attend lectures(once a month), dietary guidance or nutrition consultation at regular intervals(once every 2 weeks).	Behavioural	Nutrition education

Primary outcome

Change in Body Weight
Time frame: Baseline and 24 weeks
Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.

4 secondary outcomes

Change in Blood pressure
Time frame: Baseline and 24 weeks
Change in waist circumference, waist hip ratio, waist to height
Time frame: Baseline and 24 weeks
Change in Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm Change in fasting blood glucose
Time frame: Baseline and 24 weeks
Change in serum triglyceride, cholesterol, HDL, LDL
Time frame: Baseline and 24 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

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.

Donglian Cai, Master principal investigator

Shanghai Changhai Hospital ,Second Military Medical 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 Nutrition education in people with Metabolic Syndrome, run by Second Military Medical University 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 6 inclusion and 3 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 6 Mar 2013. 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. 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?

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?

Change in Body Weight (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01804504.

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 Mar 2013.