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

NCT07145684 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00002233K01TW012422
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Does the culturally tailored MNT lower HbA1c levels at 12 months compared to usual care?
2. 2.Does it improve dietary behaviors at 12 months compared to usual care?

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Cultural Adaptation; Medical Nutrition Therapy; Dietary Adherence; Africa

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

• Adherence to dietary recommendations

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

• Weight

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

• Height

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

• Body mass index

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

• Waist circumference

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

Study Arms (2)

OSanDiaBé intervention

EXPERIMENTAL

The Objectif Sante Diabète Bénin (OSanDiaBé) intervention group will participate in four individual home sessions and eight group sessions in the first six months, with no contact between months six and twelve. They 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.

Behavioral: A culturally tailored medical nutrition therapy

Individual standard care

NO INTERVENTION

The Individual standard care arm will be a wait-list control group who will receive standard care, including blood glucose management and general lifestyle advice, and will access the OSanDiaBe program at the end of the intervention for equitable treatment.

Interventions

A culturally tailored medical nutrition therapy BEHAVIORAL

This MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education.

OSanDiaBé intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Arizona: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

University of Abomey-Calavi

Cotonou, Littoral Department, Benin

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Waliou Amoussa-Hounkpatin, PhD

  Université d'Abomey-Calavi

  PRINCIPAL INVESTIGATOR

• Edward Bedric, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halimatou Alaofe, Ph.D

CONTACT

520-369-6356; halaofe@arizona.edu

John Ehiri, PhD

CONTACT

520-626-1355; jehiri@arizona.edu

Study Design

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

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 28, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

BE (1)