Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa
NCT ID: NCT07145684
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-10-02
2026-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Nutrition Education Groups in the Treatment of Patients with Type 2 Diabetes
NCT05598203
A Randomized Trial of an Intensive Education Intervention Using a Network of Involved Diabetic Patients (Peer Educators) to Improve Glycemic Control of Type 2 Diabetic Patients
NCT01485913
Assessing Health Outcomes in Low-income Diabetics Who Receive Monthly Boxes of Healthy Food at Clinic
NCT02917902
Remotely Delivered Mindfulness-Based Diabetes Education
NCT06312553
Community-designed Food Is Medicine for Adults With Diabetes
NCT06503861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OSanDiaBé intervention
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.
A 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.
Individual standard care
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
40 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fogarty International Center of the National Institute of Health
NIH
University of Arizona
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Halimatou Alaofe
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Waliou Amoussa-Hounkpatin, PhD
Role: PRINCIPAL_INVESTIGATOR
Université d'Abomey-Calavi
Edward Bedric, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Abomey-Calavi
Cotonou, Littoral Department, Benin
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00002233
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.