Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Cultural Adaptation, Medical Nutrition Therapy, Dietary Adherence, Africa
Brief summary
The clinical trial aims to assess the effectiveness of the Objectif Santé Diabète Benin (OSanDiaBé), a culturally tailored medical nutrition therapy (MNT), in enhancing diabetes management and nutrition choices. The investigators hypothesize that participants receiving OSanDiaBé will demonstrate greater improvements in dietary adherence and greater reductions in HbA1c at 6 months compared with those receiving usual care. The investigators further hypothesize that these improvements will be maintained at 12 months following the end of active intervention contact.
Detailed description
This study is a 12-month, parallel-group, randomized controlled trial involving individuals diagnosed with type 2 diabetes. Participants will be randomly assigned in a 1:1 ratio to either (1) usual care (wait-list control group) or (2) nutrition counseling with group-based education (intervention group). The intervention group will receive the OSanDiaBé resource package, which includes a workbook, and an Eating Plan based on the 4-A framework of food security. They will participate in four individual home sessions and eight group sessions in the first six months, with no contact between months six and twelve. The primary outcome will be the change in HbA1c levels, while secondary outcomes will include lipid profile, anthropometric measures, dietary adherence, diabetes self-efficacy, and diabetes-related quality of life. All outcomes will be assessed at baseline, 3, 6, and 12 months.
Interventions
BEHAVIORALA culturally tailored medical nutrition therapy
This MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education.
Sponsors
University of Arizona
Fogarty International Center of the National Institute of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* outpatient in one of the participating health centers * be aged between 40 and 65 years old, * have a confirmed diagnosis of T2D for a year or longer, * with uncontrolled diabetes (HbA1c \>7%) * able to read and write in French or a support who read and write in French * self-identify as Beninese (born in Benin or have parents from Benin), * willing to commit to the study and able to attend weekly meetings * have family member support for behavioral change * suitable for general diet and lifestyle advice (i.e., no complex diet needs; suitability determined by the referring healthcare provider) * be willing to provide informed consent to participate.
Exclusion criteria
* being pregnant, breastfeeding or planning pregnancy, * participants with type 1 diabetes * use of medication that might affect weight loss * planning to travel before the end of the intervention * have recent cardiovascular complications (e.g., myocardial infarction, stroke, and congestive heart failure), * currently involved in a similar nutritional educational program (to avoid contamination bias). * unable to provide consent (e.g., cognitive impairment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C (HbA1C) | HbA1c will be assessed at baseline, 3, 6, and 12 months. | A hemoglobin A1C (HbA1C) test is a blood test that shows the average level of blood glucose over the past two to three months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to dietary recommendations | Dietary adherence will be assessed at baseline, 3, 6, and 12 months. | Dietary adherence will be assessed using the modified UK Diabetes and Diet Questionnaire (UKDDQ), which consists of 22 items on dietary patterns. Responses indicate food consumption frequency and are coded as follows: A=5 (healthy), B=4 (healthy), C=3 (less healthy), D=2 (less healthy), E=1 (unhealthy), F=0 (unhealthy). Final scores range from 0 to 5, with higher scores indicating better dietary habits. |
| Weight | Weight will be assessed at baseline, 3, 6, and 12 months. | Weight will be measured in kilograms to the nearest 0.1 kg with a standard weighing scale (Hana model, China) while ensuring the participants wear light clothing and no shoes. |
| Height | Height will be assessed at baseline, 3, 6, and 12 months. | Height will be measured with a stadiometer to the nearest 0.1 cm. |
| Body mass index | BMI will be assessed at baseline, 3, 6, and 12 months. | The BMI (Body Mass Index) will be calculated using the formula: weight (kg) divided by height (m) squared. WHO classifications will be used for adult BMI: underweight (under 18.5 kg/m2), normal weight (18.5 to 24.9), overweight (25 to 29.9), and obese (30 or more). |
| Waist circumference | Waist circumference will be assessed at baseline, 3, 6, and 12 months. | The waist circumference will be measured at the umbilicus using a non-elastic tape measure while the participant stood upright, recorded in centimeters. |
| Blood pressure | Blood pressure will be assessed at baseline, 3, 6, and 12 months. | The blood pressure will be measured with a sphygmomanometer. |
| Lipid profile | Lipid profile will be assessed at baseline, 3, 6, and 12 months. | Lipid profile will include triglycerides (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C). |
| Behavioral outcomes | Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months. | The investigators will use the Academy's Evidence-Based Nutrition Practice Guidelines (AEBNPG) for MNT to track behavioral changes in meal planning, food preparation, and physical activity, rating adherence on a scale of 1 (never) to 5 (consistently). |
Countries
Benin
Contacts
PRINCIPAL_INVESTIGATORWaliou Amoussa-Hounkpatin, PhD
Université d'Abomey-Calavi
PRINCIPAL_INVESTIGATOREdward Bedric, PhD
University of Arizona
Outcome results
None listed