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OpenTrials
Completed

NCT Number: NCT01828242

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.

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Key information

Conditions

Glycemic Control for Diabetes Mellitus

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Telecommunication Company

Jakarta, Jakarta Special Capital Region, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empowerment model to improve dietary intake

Behavioral

Empowerment model using specific guidelines to improve dietary intake

Control group following conventional approach

Other

Control group following conventional approach

Primary outcomes

  1. HbA1C

    Time frame: Baseline (week 0), Endline (week 12)

Secondary outcomes

  1. Post Prandial blood glucose

    Time frame: Daily for 12 weeks

  2. Fasting Blood Glucose

    Time frame: Daily for 12 weeks

Other outcomes

  1. Iron status

    Time frame: Baseline (week 0), Endline (week 12)

Sponsors and collaborators

Lead sponsor

SEAMEO Regional Centre for Food and Nutrition

Other

Registry information

Acronym: EDMID

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 10, 2013
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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