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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled
• Intervention / Treatment: Behavioral: Nutrition education

Detailed Description

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
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • North West Province
    • Hammanskraal, North West Province, South Africa, 0400
      • Moretele Health Sub-District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Type 2 diabetes mellitus
• 40 to 70 years
• At least one year living with diabetes
• Blood sugar levels of 10mmol/L or above in at least two occasions in the last six months and consequent HbA1c levels of ≥8mmol/L
• Regular attendance of diabetic clinic

Exclusion Criteria:

• On insulin therapy
• Pregnant
• Full time employment
• Plans to move from study area during the study period

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c as a measure of glycemic control	% change from baseline, 6 months and 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary intake	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	12 months
Lipid profile	Total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglycerides, changes from baseline, 6 months and 12 months	12 months
Blood pressure	Change in blood pressure from baseline, 6 months and 12 months	12 months
Diabetes knowledge	Change in knowledge levels from the baseline, 6 months and 12 months	12 months
Attitudes toward diabetes and its treatment	Change in attitudes from baseline, 6 months and 12 months	12 months
Body mass index	Change from baseline, 6 months and 12 months	12 months

Collaborators and Investigators

• Sponsor: University of Pretoria
• Collaborators: Nestlè Nutrition Institute Africa; South African Sugar Association
• Investigators: Principal Investigator: Jane W Muchiri, PhD, University Of Pretoria; Study Chair: Paul Rheeder, PhD, University Of Pretoria

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: March 29, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (Estimate): March 30, 2010

Study Record Updates

• Last Update Posted (Estimate): January 12, 2015
• Last Update Submitted That Met QC Criteria: January 9, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Nutrition education intervention
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: MuchiriUP; DOH-27-0310-3070 (Other Identifier: South Africa Department of Health)