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

NCT01828242 | Completed Phase 2 DMC

• 1 other identifier: Empowerment for DM
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycemic Control for Diabetes Mellitus

Keywords

HbA1C

Outcome Measures

Primary Outcomes (1)

• HbA1C

  Baseline (week 0), Endline (week 12)

Secondary Outcomes (2)

• Post Prandial blood glucose

  Daily for 12 weeks

• Fasting Blood Glucose

  Daily for 12 weeks

Other Outcomes (1)

• Iron status

  Baseline (week 0), Endline (week 12)

Study Arms (2)

Empowerment model to Diabetes

EXPERIMENTAL

Empowerment model to improve dietary intake

Behavioral: Empowerment model to improve dietary intake

Control group following conventional approach

ACTIVE COMPARATOR

Control group following conventional approach

Other: Control group following conventional approach

Interventions

Empowerment model to improve dietary intake BEHAVIORAL

Empowerment model using specific guidelines to improve dietary intake

Empowerment model to Diabetes

Control group following conventional approach OTHER

Control group following conventional approach

Control group following conventional approach

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• fasting blood glucose ≥126 mg/dL
• HbA1C \>8%

You may not qualify if:

• 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.

Sponsors & Collaborators

• SEAMEO Regional Centre for Food and Nutrition: lead

Study Sites (1)

Telecommunication Company

Jakarta, Jakarta Special Capital Region, Indonesia

Location

Related Publications (9)

• 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.

  PMID: 17098087 BACKGROUND

• 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.

  PMID: 18287369 BACKGROUND

• 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.

  PMID: 11378807 BACKGROUND

• 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.

  PMID: 10938048 BACKGROUND

• 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.

  PMID: 18175767 BACKGROUND

• 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.

  PMID: 12940416 BACKGROUND

• 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.

  PMID: 20810974 BACKGROUND

• 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.

  PMID: 19397724 BACKGROUND

• 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.

  PMID: 21524316 BACKGROUND

Study Officials

• Tan S Yen, MSc

  SEAMEO-RECFON, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD Candidate (Nutrition)

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: April 10, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

ID (1)