Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 19, 2013
February 25, 2014
January 2013
December 2014   (final data collection date for primary outcome measure)
HbA1C [ Time Frame: Baseline (week 0), Endline (week 12) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01828242 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Iron status [ Time Frame: Baseline (week 0), Endline (week 12) ] [ Designated as safety issue: No ]
Same as current
 
The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control
The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Glycemic Control for Diabetes Mellitus
  • Behavioral: Empowerment model to improve dietary intake
    Empowerment model using specific guidelines to improve dietary intake
  • Other: Control group following conventional approach
    Control group following conventional approach
  • Experimental: Empowerment model to Diabetes
    Empowerment model to improve dietary intake
    Intervention: Behavioral: Empowerment model to improve dietary intake
  • Active Comparator: Control group following conventional approach
    Control group following conventional approach
    Intervention: Other: Control group following conventional approach

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01828242
Empowerment for DM
Yes
Tan Shot Yen, SEAMEO Regional Centre for Food and Nutrition
SEAMEO Regional Centre for Food and Nutrition
Not Provided
Principal Investigator: Tan S Yen, MSc SEAMEO-RECFON, University of Indonesia
SEAMEO Regional Centre for Food and Nutrition
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP