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

Primary Purpose

Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutrition education
Sponsored by
Second Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Eating out of home, Nutrition education

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Changhai Hospital,Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Nutrition education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Blood pressure
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
Change in Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm Change in fasting blood glucose
Change in serum triglyceride, cholesterol, HDL, LDL

Full Information

First Posted
February 25, 2013
Last Updated
March 5, 2013
Sponsor
Second Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01804504
Brief Title
Nutrition Education on the Metabolic Syndrome of Subjects Who Are Frequently Eating Out
Official Title
Survey on Eating Out Behavior and Dietary Structure in Urban Chinese Citizens and the Effect of Nutrition Education
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Military Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic syndrome, Eating out of home, Nutrition education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nutrition education
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Nutrition education
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
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.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Change in Blood pressure
Time Frame
Baseline and 24 weeks
Title
Change in waist circumference, waist hip ratio, waist to height
Description
Waist, hip circumference and height was measured using a plastic tape to the nearest 0.1 cm
Time Frame
Baseline and 24 weeks
Title
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
Title
Change in serum triglyceride, cholesterol, HDL, LDL
Time Frame
Baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnant woman; Temporary resident population; Participating in another clinical trial 6 months before randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donglian Cai, Master
Organizational Affiliation
Shanghai Changhai Hospital ,Second Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital,Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

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

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