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

NCT ID: NCT01828242

Last Updated: 2015-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glycemic Control for Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Empowerment model to Diabetes

Empowerment model to improve dietary intake

Group Type EXPERIMENTAL

Empowerment model to improve dietary intake

Intervention Type BEHAVIORAL

Empowerment model using specific guidelines to improve dietary intake

Control group following conventional approach

Control group following conventional approach

Group Type ACTIVE_COMPARATOR

Control group following conventional approach

Intervention Type OTHER

Control group following conventional approach

Interventions

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Empowerment model to improve dietary intake

Empowerment model using specific guidelines to improve dietary intake

Intervention Type BEHAVIORAL

Control group following conventional approach

Control group following conventional approach

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Tan Shot Yen

Medical Doctor, PhD Candidate (Nutrition)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tan S Yen, MSc

Role: PRINCIPAL_INVESTIGATOR

SEAMEO-RECFON, University of Indonesia

Locations

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Telecommunication Company

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

References

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Yoon KH, Lee JH, Kim JW, Cho JH, Choi YH, Ko SH, Zimmet P, Son HY. Epidemic obesity and type 2 diabetes in Asia. Lancet. 2006 Nov 11;368(9548):1681-8. doi: 10.1016/S0140-6736(06)69703-1.

Reference Type BACKGROUND
PMID: 17098087 (View on PubMed)

Villegas R, Shu XO, Gao YT, Yang G, Elasy T, Li H, Zheng W. Vegetable but not fruit consumption reduces the risk of type 2 diabetes in Chinese women. J Nutr. 2008 Mar;138(3):574-80. doi: 10.1093/jn/138.3.574.

Reference Type BACKGROUND
PMID: 18287369 (View on PubMed)

Sargeant LA, Khaw KT, Bingham S, Day NE, Luben RN, Oakes S, Welch A, Wareham NJ. Fruit and vegetable intake and population glycosylated haemoglobin levels: the EPIC-Norfolk Study. Eur J Clin Nutr. 2001 May;55(5):342-8. doi: 10.1038/sj.ejcn.1601162.

Reference Type BACKGROUND
PMID: 11378807 (View on PubMed)

Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.

Reference Type BACKGROUND
PMID: 10938048 (View on PubMed)

Riccardi G, Rivellese AA, Giacco R. Role of glycemic index and glycemic load in the healthy state, in prediabetes, and in diabetes. Am J Clin Nutr. 2008 Jan;87(1):269S-274S. doi: 10.1093/ajcn/87.1.269S.

Reference Type BACKGROUND
PMID: 18175767 (View on PubMed)

Bell SJ, Sears B. Low-glycemic-load diets: impact on obesity and chronic diseases. Crit Rev Food Sci Nutr. 2003;43(4):357-77. doi: 10.1080/10408690390826554.

Reference Type BACKGROUND
PMID: 12940416 (View on PubMed)

Liu S, Chou EL. Dietary glycemic load and type 2 diabetes: modeling the glucose-raising potential of carbohydrates for prevention. Am J Clin Nutr. 2010 Oct;92(4):675-7. doi: 10.3945/ajcn.2010.30187. Epub 2010 Sep 1. No abstract available.

Reference Type BACKGROUND
PMID: 20810974 (View on PubMed)

Jimenez-Monreal AM, Garcia-Diz L, Martinez-Tome M, Mariscal M, Murcia MA. Influence of cooking methods on antioxidant activity of vegetables. J Food Sci. 2009 Apr;74(3):H97-H103. doi: 10.1111/j.1750-3841.2009.01091.x.

Reference Type BACKGROUND
PMID: 19397724 (View on PubMed)

Salinero-Fort MA, Carrillo-de Santa Pau E, Arrieta-Blanco FJ, Abanades-Herranz JC, Martin-Madrazo C, Rodes-Soldevila B, de Burgos-Lunar C. Effectiveness of PRECEDE model for health education on changes and level of control of HbA1c, blood pressure, lipids, and body mass index in patients with type 2 diabetes mellitus. BMC Public Health. 2011 Apr 28;11:267. doi: 10.1186/1471-2458-11-267.

Reference Type BACKGROUND
PMID: 21524316 (View on PubMed)

Other Identifiers

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Empowerment for DM

Identifier Type: -

Identifier Source: org_study_id

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