The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control (EDMID)

June 30, 2015 updated by: Tan Shot Yen, SEAMEO Regional Centre for Food and Nutrition

Life style changes, particularly in dietary patterns have contributed a great deal to the incidence and risks of type 2 Diabetes. Decreased intakes of vegetables and fruits replaced by pre processed food, added sugar and those of animal origin lead towards rapid increase of adult-onset-diabetes.

In spite of the knowledge of the benefit of consuming vegetable and fruits, and people are well informed, they still need to be committed to perform a behavior and implement these intention. Behavioral approach methods have demonstrated successful adherence in health education with life style changes.

Objective: To identify the impact of The Empowerment Model to enhance vegetable intake in Type 2 Diabetes Mellitus adults in achieving glycemic control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Telecommunication Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fasting blood glucose ≥126 mg/dL
  • HbA1C >8%

Exclusion Criteria:

  • those who have serious, unstable medical conditions, or related to metabolic disorders (i.e. thyroid diseases)
  • significant co-morbid illnesses such as liver disease, kidney disease, cancer, bowel diseases/ malfunction, pregnancy or nursing mothers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Empowerment model to Diabetes
Empowerment model to improve dietary intake
Behavioral: Empowerment model to improve dietary intake
Empowerment model using specific guidelines to improve dietary intake
ACTIVE_COMPARATOR: Control group following conventional approach
Other: Control group following conventional approach
Control group following conventional approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1C
Time Frame: Baseline (week 0), Endline (week 12)
Baseline (week 0), Endline (week 12)

Secondary Outcome Measures

Outcome Measure
Time Frame
Post Prandial blood glucose
Time Frame: Daily for 12 weeks
Daily for 12 weeks
Fasting Blood Glucose
Time Frame: Daily for 12 weeks
Daily for 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Iron status
Time Frame: Baseline (week 0), Endline (week 12)
Baseline (week 0), Endline (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEAMEO Regional Centre for Food and Nutrition

Investigators

  • Principal Investigator: Tan S Yen, MSc, SEAMEO-RECFON, University of Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (ESTIMATE)

April 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Empowerment for DM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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