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Nutrition Education Intervention for Adults With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03334773
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Behavioral: Nutrition education

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention (nutrition education programme) will employ a randomised control design with two parallel groups (intervention & control). Randomisation will be stratified based on age and gender into four strata. Concealed opaque envelopes for each stratum will be used for randomization. The intervention will be implemented over one year. The (intervention) comprises of four components i) 7-monthly group training (curriculum), ii) 2 bi-monthly group follow-up sessions, iii) one individual counseling and goal setting session (10-15 minutes) fitted during the monthly meetings, and iv) participant's workbook for goal setting activity and education materials (fridge/wall poster, pamphlet). The intervention group will receive the intervention while the control group will only receive the education material (fridge/wall poster, pamphlet). Both groups will continue with usual care at the diabetes outpatient clinic of the hospital.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:
The health professionals (physicians, dietitians, nursing professionals) who serve the patients will only know the patient is participating in the study through a sticker on the medical records but they will not know the treatment allocation (group). Outcome assessors for biochemical parameters will not know the patient allocation as the assessments for the parameters are done alongside other routine assessments. Furthermore, they do not have the information that there are different patient groups
Primary Purpose: Other
Official Title: Nutrition Education Intervention for Adults With Type 2 Diabetes Receiving Outpatient Services at a Teaching Tertiary Hospital in Tshwane District
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intervention group
Nutrition education (group inclusive of education materials)
Behavioral: Nutrition education
Other Name: Lifestyle: dietary behaviours
No Intervention: Control group
Only receives education materials


Outcome Measures

Primary Outcome Measures :
  1. Hemoglobin A1c levels (HbA1c) [ Time Frame: 6 months and 12 months ]
    % change


Secondary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: 6 months and 12 mo nths ]
    Mean (Kg/m2)

  2. Total cholesterol [ Time Frame: 6 months and 12 months ]
    Mean (mmol/L)

  3. LDL-cholesterol [ Time Frame: 6 months and 12 months ]
    Mean (mmol/L)

  4. HDL-cholesterol [ Time Frame: 6 months and 12 months ]
    Mean (mmol/L)

  5. Triglycerides [ Time Frame: 6 months and 12 months ]
    Mean (mmol/L)

  6. Hemoglobin A1c targets [ Time Frame: 6 months and 12 months ]
    Proportion (%) with <7%

  7. Dietary energy intake [ Time Frame: 6 months and 12 months ]
    Mean/median energy intake (KJ/day)

  8. Vegetables and fruits intake [ Time Frame: 6 months and 12 months ]
    Mean/median vegetables and fruit intake (servings/day)

  9. Starchy foods intake [ Time Frame: 6 months and 12 months ]
    Mean/median starchy food intake (servings/day)

  10. Dietary fibre intake [ Time Frame: 6 months and 12 months ]
    Mean/median fibre intake (g/day)

  11. Dietary behaviours [ Time Frame: 6 months and 12 months ]
    Mean/median macronutrient contribution to energy (%)

  12. 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.

  13. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334773


Contacts
Contact: Postdoctoral fellow +27123563200 ext 3207 jane.muchiri@up.ac.za
Contact: Head: Department of Human Nutrition +27123563200 ext 3199 gerda.gericke@up.ac.za

Locations
South Africa
Steve Biko Academic Hospital Recruiting
Pretoria, Gauteng, South Africa, 0001
Contact: Professor    +27 3543861 ext 3861    paul.rheeder@up.ac.za   
Sponsors and Collaborators
University of Pretoria
South African Sugar Association
Investigators
Principal Investigator: Postdoctoral fellow University of Pretoria
More Information

Responsible Party: Jane Muchiri, Principal Investigator, University of Pretoria
ClinicalTrials.gov Identifier: NCT03334773     History of Changes
Other Study ID Numbers: 4/2016
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jane Muchiri, University of Pretoria:
Type 2 diabetes, nutrition education programme, intervention, South Africa

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