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

This study has been completed.
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: June 30, 2015
Last verified: June 2015
  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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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 Tan Shot Yen, SEAMEO Regional Centre for Food and Nutrition:

Primary Outcome Measures:
  • HbA1C [ Time Frame: Baseline (week 0), Endline (week 12) ]

Secondary Outcome Measures:
  • Post Prandial blood glucose [ Time Frame: Daily for 12 weeks ]
  • Fasting Blood Glucose [ Time Frame: Daily for 12 weeks ]

Other Outcome Measures:
  • Iron status [ Time Frame: Baseline (week 0), Endline (week 12) ]

Enrollment: 84
Study Start Date: January 2013
Study Completion Date: December 2014
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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 30, 2015

Keywords provided by Tan Shot Yen, SEAMEO Regional Centre for Food and Nutrition:
HbA1C

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 27, 2017