Nutrition Education Intervention for Adults With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

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.
    

Intervention name(s): Nutrition education
Intervention type(s): Behavioral
Other intervention name(s): Lifestyle: dietary behaviours
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)
Primary purpose: Other
Keywords: Type 2 diabetes, nutrition education programme, intervention, South Africa