Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa

N/AActive Not RecruitingNCT07145684

University of Arizona64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Hemoglobin A1C (HbA1C)

A hemoglobin A1C (HbA1C) test is a blood test that shows the average level of blood glucose over the past two to three months.

Time frame: HbA1c will be assessed at baseline, 3, 6, and 12 months.

Secondary Outcomes

Adherence to dietary recommendations

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.

Time frame: Dietary adherence will be assessed at baseline, 3, 6, and 12 months.

Weight

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.

Time frame: Weight will be assessed at baseline, 3, 6, and 12 months.

Height

Height will be measured with a stadiometer to the nearest 0.1 cm.

Time frame: Height will be assessed at baseline, 3, 6, and 12 months.

Body mass index

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).

Time frame: BMI will be assessed at baseline, 3, 6, and 12 months.

Waist circumference

The waist circumference will be measured at the umbilicus using a non-elastic tape measure while the participant stood upright, recorded in centimeters.

Time frame: Waist circumference will be assessed at baseline, 3, 6, and 12 months.

Blood pressure

The blood pressure will be measured with a sphygmomanometer.

Time frame: Blood pressure will be assessed at baseline, 3, 6, and 12 months.

Lipid profile

Lipid profile will include triglycerides (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C).

Time frame: Lipid profile will be assessed at baseline, 3, 6, and 12 months.

Behavioral outcomes

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).

Time frame: Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months.