NCT01095965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

1.6 years

First QC Date

March 29, 2010

Last Update Submit

January 9, 2015

Conditions

Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled

Keywords

Nutrition education interventionType 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c as a measure of glycemic control

    % change from baseline, 6 months and 12 months

    12 months

Secondary Outcomes (6)

  • Dietary intake

    12 months

  • Lipid profile

    12 months

  • Blood pressure

    12 months

  • Diabetes knowledge

    12 months

  • Attitudes toward diabetes and its treatment

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Lifestyle education

EXPERIMENTAL

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

Interventions

Nutrition educationBEHAVIORAL

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

Lifestyle education

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moretele Health Sub-District

Hammanskraal, North West, 0400, South Africa

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Jane W Muchiri, PhD

    University of Pretoria

    PRINCIPAL INVESTIGATOR

  • Paul Rheeder, PhD

    University of Pretoria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 30, 2010

Study Start

April 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

January 12, 2015

Record last verified: 2015-01

Locations

ZA(1)