Completed

EDMIDThe Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control

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What is being tested

Empowerment model to improve dietary intake

+ Control group following conventional approach

BehavioralOther
Who is being recruted

From 18 to 55 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 2
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorSEAMEO Regional Centre for Food and Nutrition
Last updated: July 1, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01828242
Principal SponsorSEAMEO Regional Centre for Food and Nutrition
Last updated: July 1, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

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

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
HbA1C > 8%
fasting blood glucose >= 126 mg/dL
2 exclusion criteria prevent from participating
significant co-morbid illnesses such as liver disease, kidney disease, cancer, bowel diseases/ malfunction, pregnancy or nursing mothers
those who have serious, unstable medical conditions, or related to metabolic disorders (i.e. thyroid diseases)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Empowerment model to improve dietary intake

Group II

Active Comparator
Control group following conventional approach

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Telecommunication Company

Jakarta, IndonesiaOpen Telecommunication Company in Google Maps
CompletedOne Study Center