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Nutrition Education Intervention in Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting

NCT01095965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2015-01-12

No results posted yet for this study

Summary

The purpose of this study is to implement a nutrition education programme that was developed for type 2 diabetic adults in a resource poor setting and to evaluate the programme's effectiveness on health outcomes

A randomized controlled clinical trial study design will be used. One group (experimental group) will receive the nutrition education while the other group (control group) will receive the usual care.

Setting: Two Community health centres in Moretele Health Sub-District, North West Province, South, Africa

Effectiveness of the nutrition education will be evaluated for the following outcomes:

* clinical

* blood sugar control based on HbA1c levels (primary outcome)
* lipid profile (total cholesterol, low density cholesterol, high density cholesterol and triglycerides)
* blood pressure
* body mass index
* dietary intake
* others -diabetes knowledge, attitudes towards diabetes

Outcome measurements- at six and 12 months, this will be compared with the baseline data.

Hypotheses:

* the experimental group will have a significantly lower HbA1c compared to the control group
* the experimental group will have significantly better outcomes for dietary intake, blood lipid profile, blood pressure, body mass index, diabetes knowledge and attitudes towards diabetes and its treatment.

Conditions

  • Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled

Interventions

BEHAVIORAL

Nutrition education

Group education on a bi-weekly basis for eight weeks plus written education materials, followed by monthly group problem solving meetings till one year.

Sponsors & Collaborators

  • South African Sugar Association

    collaborator UNKNOWN

  • Nestlè Nutrition Institute Africa

    collaborator OTHER

  • University of Pretoria

    lead OTHER

Principal Investigators

  • Jane W Muchiri, PhD · University of Pretoria

  • Paul Rheeder, PhD · University of Pretoria

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095965 on ClinicalTrials.gov