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NCT Number: NCT01095965

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

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.

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Key information

Conditions

Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moretele Health Sub-District

Hammanskraal, North West, 0400, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutrition Education

Behavioral

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

Primary outcomes

  1. HbA1c as a measure of glycemic control

    Time frame: 12 months

    % change from baseline, 6 months and 12 months

Secondary outcomes

  1. 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

  2. Lipid profile

    Time frame: 12 months

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglycerides, changes from baseline, 6 months and 12 months

  3. Blood pressure

    Time frame: 12 months

    Change in blood pressure from baseline, 6 months and 12 months

  4. Diabetes knowledge

    Time frame: 12 months

    Change in knowledge levels from the baseline, 6 months and 12 months

  5. Attitudes toward diabetes and its treatment

    Time frame: 12 months

    Change in attitudes from baseline, 6 months and 12 months

  6. Body mass index

    Time frame: 12 months

    Change from baseline, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

University of Pretoria

Other

Collaborators

  • Nestlè Nutrition Institute Africa
  • South African Sugar Association

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 30, 2010
Registry last updated
Jan 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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