Clinical trial NCT01828242: The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control
Official title: The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glycemic Control for Diabetes Mellitus
Keywords: HbA1C
Lead sponsor: SEAMEO Regional Centre for Food and Nutrition
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: HbA1C
timeFrame: Baseline (week 0), Endline (week 12)
Secondary outcomes:
measure: Post Prandial blood glucose
timeFrame: Daily for 12 weeks
measure: Fasting Blood Glucose
timeFrame: Daily for 12 weeks
Other outcomes:
measure: Iron status
timeFrame: Baseline (week 0), Endline (week 12)
Locations:
city: Jakarta
country: Indonesia
facility: Telecommunication Company
Study officials:
affiliation: SEAMEO-RECFON, University of Indonesia
name: Tan S Yen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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