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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01828242
Other study ID # Empowerment for DM
Secondary ID
Status Completed
Phase Phase 2
First received March 19, 2013
Last updated June 30, 2015
Start date January 2013
Est. completion date December 2014

Study information

Verified date June 2015
Source SEAMEO Regional Centre for Food and Nutrition
Contact n/a
Is FDA regulated No
Health authority The Committee of the Medical Research Ethic of the Faculty of Medicine, University of Indonesia:Indonesia
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Glycemic Control for Diabetes Mellitus

Intervention

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

Locations

Country Name City State
Indonesia Telecommunication Company Jakarta

Sponsors (1)

Lead Sponsor Collaborator
SEAMEO Regional Centre for Food and Nutrition

Country where clinical trial is conducted

Indonesia, 

References & Publications (9)

Bell SJ, Sears B. Low-glycemic-load diets: impact on obesity and chronic diseases. Crit Rev Food Sci Nutr. 2003;43(4):357-77. Review. — View Citation

Jiménez-Monreal AM, García-Diz L, Martínez-Tomé 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. — View Citation

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. — View Citation

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. Review. — View Citation

Salinero-Fort MA, Carrillo-de Santa Pau E, Arrieta-Blanco FJ, Abanades-Herranz JC, Martín-Madrazo C, Rodés-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Iron status Baseline (week 0), Endline (week 12) No
Primary HbA1C Baseline (week 0), Endline (week 12) No
Secondary Post Prandial blood glucose Daily for 12 weeks No
Secondary Fasting Blood Glucose Daily for 12 weeks No