NCT01804504

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

February 25, 2013

Last Update Submit

March 5, 2013

Conditions

Keywords

Metabolic syndromeEating out of homeNutrition education

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 24 weeks

Secondary Outcomes (4)

  • Change in Blood pressure

    Baseline and 24 weeks

  • Change in waist circumference, waist hip ratio, waist to height

    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

    Baseline and 24 weeks

  • Change in serum triglyceride, cholesterol, HDL, LDL

    Baseline and 24 weeks

Study Arms (2)

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

Behavioral: Nutrition education

Interventions

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).

Nutrition education

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital,Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Donglian Cai, Master

    Shanghai Changhai Hospital ,Second Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 5, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations