Nutrition Education Intervention for Adults With Type 2 Diabetes

April 6, 2020 updated by: Jane Muchiri, University of Pretoria

Nutrition Education Intervention for Adults With Type 2 Diabetes Receiving Outpatient Services at a Teaching Tertiary Hospital in Tshwane District

Aim: To implement a nutrition education programme (intervention) for adults with type 2 diabetes mellitus (T2DM) adapted from a primary health care setting to a tertiary hospital setting in South Africa and to evaluate the programme's effectiveness on dietary behaviours, clinical status and selected potential behaviour mediators.

Participants and setting: T2DM adults (40-70 years) and at least one year of living with diabetes and poorly controlled diabetes (HbA1c ≥ 8%). The study setting is the outpatient clinic of a tertiary teaching hospital in Tshwane District (Pretoria), South Africa.

Intervention: The intervention will employ a randomised control design with two parallel groups (intervention & control). A total sample of 140 T2DM patients (70 per group) will be needed to detect a 0.5 % change in HbA1c (SD of 1.0 and a power of 80%) at six month and allowing a 10% attrition rate. The intervention is one-year long with the following components: 7-monthly group education sessions; 2 bi-monthly group follow-up sessions at the hospital till one year; participants' workbook for goal setting activities and education materials (pamphlet and wall/fridge poster) for the intervention group. The control group will receive the same education materials with no other education encounters. Both groups will continue with usual care at the diabetes outpatient clinic of the hospital. The education will be offered face to face, will utilize teaching aids including coloured posters and will incorporate interactive group activities and demonstrations. The main facilitator is a qualified dietitian.

Outcomes: Outcomes will be assessed at 6-and 12 months for both groups with the six month being the primary outcome. Outcomes will include clinical [HbA1c (primary outcome), BMI, blood pressure and full lipid profile); dietary behaviours (energy intake, starchy food servings, vegetable and fruits intake, macronutrient intake and their distribution to energy, fibre, meal pattern) and selected potential mediators of behavior (diabetes knowledge and diabetes management self- efficacy).

It is hypothesized that the intervention will lower the HbA1c levels by at least 0.5% at six months and the levels will be significantly lower in the intervention group compared with the control group, and the significantly lower levels will be sustained at 12 months in the intervention group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aim of the study: To implement a nutrition education program (intervention) for adults with type 2 diabetes mellitus (T2DM) adapted from a primary health care setting to a tertiary hospital setting in South Africa and to evaluate the program's effectiveness on dietary behaviors, clinical status and selected potential behavior mediators.

General objectives

• The implementation of the adapted nutrition education program (NEP) at the diabetes outpatient clinic of a tertiary teaching hospital

• The evaluation of the program's effectiveness at six and 12 months on the following outcomes: (i) clinical status: Hemoglobin A1c (HbA1c) (primary outcome), BMI, blood pressure and lipid profile (ii) dietary behaviors (energy intake, starchy food servings, vegetable and fruits intake, macronutrient intake and their distribution to energy as a measure of meal balance, fiber and legume intake) (iii) potential behavior mediators (diabetes knowledge, diabetes management self-efficacy).

Primary outcome objective

• To determine the differences between the intervention and control groups at six months for HbA1c, (primary outcome).

Secondary outcome objectives

  • To determine the differences between the intervention and control groups at 12 months for HbA1c
  • To determine the differences between the intervention and control groups at six months and 12 months for the secondary outcomes: dietary behaviors, BMI, lipid profile, blood pressure, diabetes knowledge and self-efficacy for diabetes management
  • To determine the differences between the intervention and control groups in the proportion of participants who achieve HbA1c levels of less than 7%.

Research hypotheses (i) The intervention will lower the HbA1c levels by at least 0.5% at six months and the levels will be significantly lower in the intervention group compared with the control group, and the significantly lower levels will be sustained at 12 months in the intervention group.

(ii) The intervention group will have significantly better outcomes in the secondary outcomes (blood lipid levels, BMI, blood pressure, dietary behaviors, diabetes knowledge and self-efficacy) at six months and would sustain significantly better outcomes at 12 months compared with the control group.

(iii) The intervention group compared with the control group would have significantly more participants achieving the HbA1c targets (<7%) at six months and at 12 months.

Study design The intervention will employ a randomized controlled clinical trial design using two parallel groups. One group (intervention) will receive the intervention (diabetes nutrition education) including education materials while the other group (control) will only receive the education materials. Both groups will continue with usual medical care at the diabetes outpatient clinic.

Setting and participants: The study setting is the outpatient clinic of a tertiary teaching hospital in Pretoria, South Africa. Participants are male and female T2DM adults (40-70 years) and at least one year of living with diabetes and poorly controlled diabetes (HbA1c ≥ 8%). Participants with no major complications, who are not pregnant or on full time employment and can understand English will be included. A total sample of 140 T2DM patients (70 per group) will be needed to detect a 0.5 % change in HbA1c (SD of 1.0 and a power of 80%) at six month and allowing a 10% attrition rate. A convenience sample of consequent patients will be used. Participants will be recruited face to face during their clinic attendance.

Randomization Participants will be randomised into either the intervention or control group using block randomisation in blocks of varying sizes using a computer generated random schedule. The participants will be stratified based on sex and age. Allocation concealment using sealed sequentially numbered opaque envelopes with the randomisation code will be done (Sex-age stratum will have its own set of the sequentially numbered opaque envelope).

Intervention: The intervention aims to improve glycaemic control and other clinical outcomes (BMI, lipid profile, blood pressure) through improved dietary behaviours and behaviour mediating factors. The intervention is one-year long.

The intervention group will receive the following components:

  • Face to face 7-monthly group education sessions, 2 bi-monthly group follow-up sessions at the hospital up to one year and one individual counseling and goal setting activity
  • Participate in individual goal setting activities at home using a workbook and receive education materials (pamphlet and wall/fridge poster) for use at home.

The education will be offered face to face, will utilize teaching aids including colorful posters and will incorporate interactive group activities and demonstrations. Participants will be encouraged to bring a family member or a friend. The main facilitator is a qualified dietitian.

The control group will receive the same education materials with no other education encounters. Both groups will continue with usual care at the diabetes outpatient clinic of the hospital.

Outcomes measurement: Outcomes will be assessed at 6-and 12 months for both groups with the six month being the primary outcome.

  • Clinical outcomes: HbA1c (primary outcome), BMI, blood pressure and full lipid profile) will be measured using standard procedures.
  • Dietary behaviors (energy intake, starchy food servings, vegetable and fruits intake, legume intake, macronutrient intake and their distribution to energy as a measure of meal balance and fibre). Three non-consecutive 24hour recalls (including one weekend day) will assess dietary intake. Standardized household measures will be used to help with portion estimation.
  • Potential mediators of behavior (diabetes knowledge and diabetes self-management efficacy). Questionnaires considered as suitable measures for the outcomes and appropriate for use with the target population (through pilot testing) will be used. The questionnaires have been used in diverse settings and geographical locations.

Process evaluation: Quantitative and qualitative measures will be used to confirm fidelity, reach and participants experience with the programme.

Data analysis:

An analysis of co-variance (ANCOVA) will compare the intervention and control groups on the measured outcomes post-intervention, using the baseline values age and gender as covariates. An intention to treat analysis will be performed on all outcomes using the last observed response (carry forward). The level of significance for all tests will be at α < 0.05 for a two-tailed test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Steve Biko Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type diabetes mellitus, poorly controlled (HbA1c > % 8), at least one year living with diabetes, without serious complications, mobile, regular attendance of diabetes clinic, not on full time employment, not planning to leave study site in the next one year.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Nutrition education (group inclusive of education materials)
Behavioral: Nutrition education
Other Names:
  • Lifestyle: dietary behaviours
No Intervention: Control group
Only receives education materials

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c levels (HbA1c)
Time Frame: 6 months and 12 months
% change
6 months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body mass index (BMI)
Time Frame: 6 months and 12 mo nths
Mean (Kg/m2)
6 months and 12 mo nths
Total cholesterol
Time Frame: 6 months and 12 months
Mean (mmol/L)
6 months and 12 months
LDL-cholesterol
Time Frame: 6 months and 12 months
Mean (mmol/L)
6 months and 12 months
HDL-cholesterol
Time Frame: 6 months and 12 months
Mean (mmol/L)
6 months and 12 months
Triglycerides
Time Frame: 6 months and 12 months
Mean (mmol/L)
6 months and 12 months
Hemoglobin A1c targets
Time Frame: 6 months and 12 months
Proportion (%) with <7%
6 months and 12 months
Dietary energy intake
Time Frame: 6 months and 12 months
Mean/median energy intake (KJ/day)
6 months and 12 months
Vegetables and fruits intake
Time Frame: 6 months and 12 months
Mean/median vegetables and fruit intake (servings/day)
6 months and 12 months
Starchy foods intake
Time Frame: 6 months and 12 months
Mean/median starchy food intake (servings/day)
6 months and 12 months
Dietary fibre intake
Time Frame: 6 months and 12 months
Mean/median fibre intake (g/day)
6 months and 12 months
Dietary behaviours
Time Frame: 6 months and 12 months
Mean/median macronutrient contribution to energy (%)
6 months and 12 months
Diabetes knowledge
Time Frame: 6 months and 12 months
Diabetes related knowledge (Diet, blood glucose control, exercise, medication taking, complications) using the Simplified Revised Diabetes Knowledge Scale (True/false). % Mean correct scores (0-100%) for 18 items (non-insulin users) or 20 items (insulin users). Higher score indicates better outcome.
6 months and 12 months
Diabetes management self-efficacy
Time Frame: 6 months and 12 months
Diabetes management self-efficacy scale, four scales (Nutrition; exercise and weight; Medical treatment; Blood sugar and feet check) and 17 items on a scale of 0 to 10. Possible scores is 0 to 10, (higher score indicating better outcome). Mean scores for the whole scale will be computed without weighting as well as the mean score for each subscale
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pretoria

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South African Sugar Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Postdoctoral fellow, University of Pretoria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Masters student undertaking an aspects of the project (e.g baseline). Data will be available after all baseline data is complete-anticipated 8-months from commencing recruitment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on Nutrition education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings