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

University of Arizona

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Behavioral: A culturally tailored medical nutrition therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07145684

K01TW012422 (U.S. NIH Grant/Contract)

STUDY00002233

Details and patient eligibility

About

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?

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

OSanDiaBé intervention

Experimental group

Description:

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.

Treatment:

Behavioral: A culturally tailored medical nutrition therapy

Individual standard care

No Intervention group

Description:

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.