Clinical trial NCT01095965: Nutrition Education Intervention in Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled
Keywords: Nutrition education intervention
Type 2 diabetes mellitus
Lead sponsor: University of Pretoria
Sponsor class: OTHER
Collaborators: name: South African Sugar Association
name: Nestlè Nutrition Institute Africa
First posted: 2010-03-30
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c as a measure of glycemic control
timeFrame: 12 months
Secondary outcomes:
measure: Dietary intake
timeFrame: 12 months
measure: Lipid profile
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Diabetes knowledge
timeFrame: 12 months
measure: Attitudes toward diabetes and its treatment
timeFrame: 12 months
measure: Body mass index
timeFrame: 12 months
Other outcomes:
Locations:
city: Hammanskraal
country: South Africa
facility: Moretele Health Sub-District
state: North West Province
Study officials:
affiliation: University of Pretoria
name: Jane W Muchiri, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pretoria
name: Paul Rheeder, PhD
role: STUDY_CHAIR
References: