Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] UncontrolledNCT01095965
Nutrition Education Intervention in Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting
A study testing Nutrition education in people with Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled, run by University of Pretoria at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled
- What is being tested?
- Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Africa
- Study dates
- Apr 2010to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- On insulin therapy
- Pregnant
- Full time employment
- Plans to move from study area during the study period
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Moretele Health Sub-District
Hammanskraal, North West, 0400
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Nutrition education
- Keywords
- Nutrition education intervention, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition educationBehavioural
Group education on a bi-weekly basis for eight weeks plus written education materials, followed by monthly group problem solving meetings till one year.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c as a measure of glycemic control
% change from baseline, 6 months and 12 months
Measured: 12 months
Secondary outcomes (6)
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
Measured: 12 months
Lipid profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglycerides, changes from baseline, 6 months and 12 months
Measured: 12 months
Blood pressure
Change in blood pressure from baseline, 6 months and 12 months
Measured: 12 months
Diabetes knowledge
Change in knowledge levels from the baseline, 6 months and 12 months
Measured: 12 months
Attitudes toward diabetes and its treatment
Change in attitudes from baseline, 6 months and 12 months
Measured: 12 months
Body mass index
Change from baseline, 6 months and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] UncontrolledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Collaborators
- South African Sugar Association, Nestlè Nutrition Institute Africa
- Responsible party
- Principal investigator, Jane Muchiri, University of Pretoria
- Investigators
- Jane W Muchiri, PhD, Principal investigator, University of PretoriaPaul Rheeder, PhD, Study chair, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095965
- Sponsor's protocol ID
- MuchiriUP
- Other IDs
- DOH-27-0310-3070
- Status last verified
- Jan 2015
- First submitted
- 29 Mar 2010
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01095965
- Acronym / sponsor ID
- MuchiriUP
- Keywords
- Nutrition education intervention, Type 2 diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Collaborators
- South African Sugar Association, Nestlè Nutrition Institute Africa
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle education | Experimental | Behavioral: Nutrition educationNutrition 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- On insulin therapy
- Pregnant
- Full time employment
- Plans to move from study area during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition educationGroup education on a bi-weekly basis for eight weeks plus written education materials, followed by monthly group problem solving meetings till one year. | Behavioural | Lifestyle education |
Primary outcome
HbA1c as a measure of glycemic control
Time frame: 12 months
% change from baseline, 6 months and 12 months
6 secondary outcomes
Dietary intake
Time frame: 12 months
Lipid profile
Time frame: 12 months
Blood pressure
Time frame: 12 months
Diabetes knowledge
Time frame: 12 months
Attitudes toward diabetes and its treatment
Time frame: 12 months
Body mass index
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane W Muchiri, PhD principal investigator
University of Pretoria
Paul Rheeder, PhD study chair
University of Pretoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition education in people with Diabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] Uncontrolled, run by University of Pretoria at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c as a measure of glycemic control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2015.