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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tan Shot Yen, SEAMEO Regional Centre for Food and Nutrition
ClinicalTrials.gov Identifier:
NCT01828242
First received: March 19, 2013
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Glycemic Control for Diabetes Mellitus
Behavioral: Empowerment model to improve dietary intake
Other: Control group following conventional approach
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control

Resource links provided by NLM:


Further study details as provided by SEAMEO Regional Centre for Food and Nutrition:

Primary Outcome Measures:
  • HbA1C [ Time Frame: Baseline (week 0), Endline (week 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post Prandial blood glucose [ Time Frame: Daily for 12 weeks ] [ Designated as safety issue: No ]
  • Fasting Blood Glucose [ Time Frame: Daily for 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Iron status [ Time Frame: Baseline (week 0), Endline (week 12) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Control group following conventional approach
Other: Control group following conventional approach
Control group following conventional approach

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01828242

Locations
Indonesia
Telecommunication Company
Jakarta, Indonesia
Sponsors and Collaborators
SEAMEO Regional Centre for Food and Nutrition
Investigators
Principal Investigator: Tan S Yen, MSc SEAMEO-RECFON, University of Indonesia
  More Information

Publications:

Responsible Party: Tan Shot Yen, Medical Doctor, PhD Candidate (Nutrition), SEAMEO Regional Centre for Food and Nutrition
ClinicalTrials.gov Identifier: NCT01828242     History of Changes
Other Study ID Numbers: Empowerment for DM
Study First Received: March 19, 2013
Last Updated: February 25, 2014
Health Authority: The Committee of the Medical Research Ethic of the Faculty of Medicine, University of Indonesia:Indonesia

Keywords provided by SEAMEO Regional Centre for Food and Nutrition:
HbA1C

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014