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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
South African Sugar Association
Information provided by:
University of Pretoria
ClinicalTrials.gov Identifier:
NCT01095965
First received: March 29, 2010
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled
 Behavioral: Nutrition education
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pretoria:

Primary Outcome Measures:
  • HbA1c as a measure of glycemic control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    % change from baseline, 6 months and 12 months


Secondary Outcome Measures:
  • Dietary intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglycerides, changes from baseline, 6 months and 12 months

  • Blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in blood pressure from baseline, 6 months and 12 months

  • Diabetes knowledge [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in knowledge levels from the baseline, 6 months and 12 months

  • Attitudes toward diabetes and its treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in attitudes from baseline, 6 months and 12 months

  • Body mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change from baseline, 6 months and 12 months


Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095965

Locations
South Africa
Moretele Health Sub-District
Hammanskraal, North West Province, South Africa, 0400
Sponsors and Collaborators
University of Pretoria
South African Sugar Association
Investigators
Principal Investigator: Jane W Muchiri, Msc University of Pretoria
Study Chair: Paul Rheeder, PhD University of Pretoria
  More Information

No publications provided

Responsible Party: Jane Muchiri, University of Pretoria
ClinicalTrials.gov Identifier: NCT01095965     History of Changes
Other Study ID Numbers: MuchiriUP, DOH-27-0310-3070
Study First Received: March 29, 2010
Last Updated: August 11, 2011
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by University of Pretoria:
Nutrition education intervention
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013