Nutrition Education Intervention in Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting
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|ClinicalTrials.gov Identifier: NCT01095965|
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : January 12, 2015
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled||Behavioral: Nutrition education||Not Applicable|
Type 2 diabetes mellitus (DM) is a global health challenge. Low-income individuals are among those observed to have poorer long term outcomes of diabetes management and to spend a higher proportion of their income on diabetes care. Therefore, diabetic individuals from resource poor settings require special attention and effective management strategies to assist them improve their health outcomes. Patient self-management education, including nutrition education is a feasible strategy in resource poor settings.
The nutrition education programme in this study is based on the target group assessed needs, as tailored education is shown to be more effective in improving health outcomes.
The experimental group will receive nutrition education in group format on a weekly basis for eight weeks, this will include a vegetable gardening component offered in collaboration with the Department of Agriculture. In addition written education materials will be provided (pamphlet and wall/fridge flyer). A follow-up intervention on a monthly basis will follow the group education.This is to revise the learnt content and for group problem solving activities. The control control group will receive usual care plus the written education materials.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation and Evaluation of a Nutrition Education Programme for Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting of the Moretele Sub-District, North West Province, South Africa|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: Lifestyle education
Nutrition education comprised of 4 components: Curriculum (8 weeks), follow-up meetings (4 monthly plus 2-bimonthly), education materials for use at home and vegetable gardening demonstrations.
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.
- HbA1c as a measure of glycemic control [ Time Frame: 12 months ]% change from baseline, 6 months and 12 months
- Dietary intake [ Time Frame: 12 months ]Contribution of macronutrients to total energy intake, intake of fibre, intake of micronutrients, portion sizes, intake of fruits and vegetables, change from baseline, 6 months and 12 months
- Lipid profile [ Time Frame: 12 months ]Total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglycerides, changes from baseline, 6 months and 12 months
- Blood pressure [ Time Frame: 12 months ]Change in blood pressure from baseline, 6 months and 12 months
- Diabetes knowledge [ Time Frame: 12 months ]Change in knowledge levels from the baseline, 6 months and 12 months
- Attitudes toward diabetes and its treatment [ Time Frame: 12 months ]Change in attitudes from baseline, 6 months and 12 months
- Body mass index [ Time Frame: 12 months ]Change from baseline, 6 months and 12 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095965
|Moretele Health Sub-District|
|Hammanskraal, North West Province, South Africa, 0400|
|Principal Investigator:||Jane W Muchiri, PhD||University of Pretoria|
|Study Chair:||Paul Rheeder, PhD||University of Pretoria|