Nutrition Education Intervention for Adults With Type 2 Diabetes

NCT03334773 | Completed

• 1 other identifier: 4/2016
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes, nutrition education programme, intervention, South Africa

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c levels (HbA1c)

  % change

  6 months and 12 months

Secondary Outcomes (13)

• Body mass index (BMI)

  6 months and 12 mo nths

• Total cholesterol

  6 months and 12 months

• LDL-cholesterol

  6 months and 12 months

• HDL-cholesterol

  6 months and 12 months

• Triglycerides

  6 months and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Nutrition education (group inclusive of education materials)

Behavioral: Nutrition education

Control group

NO INTERVENTION

Only receives education materials

Interventions

Nutrition education BEHAVIORAL

Also known as: Lifestyle: dietary behaviours

Intervention group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pretoria: lead
• South African Sugar Association: collaborator

Study Sites (1)

Steve Biko Academic Hospital

Pretoria, Gauteng, 0001, South Africa

Location

Related Publications (1)

• Muchiri JW, Gericke GJ, Rheeder P. Effectiveness of an adapted diabetes nutrition education program on clinical status, dietary behaviors and behavior mediators in adults with type 2 diabetes: a randomized controlled trial. J Diabetes Metab Disord. 2021 Feb 4;20(1):293-306. doi: 10.1007/s40200-021-00744-z. eCollection 2021 Jun.

  PMID: 34222067 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Postdoctoral fellow

  University of Pretoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 7, 2017
• Study Start: January 16, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

ZA (1)