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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT07145684
• Lead Sponsor: University of Arizona

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. It seeks to answer two main questions:

1. Does the culturally tailored MNT lower HbA1c levels at 12 months compared to usual care?

2. Does it improve dietary behaviors at 12 months compared to usual care?

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 weekly presentations, 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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Study Start: 2025-10-02
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. We will use WHO classifications 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.	We 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).

Trial Locations

Locations (1)

University of Abomey-Calavi; 🇧🇯 Cotonou, Littoral Department, Benin