Type 2 DiabetesOSanDiaBéNCT07145684
Culturally Tailored Nutrition Therapy to Improve Dietary Adherence of Type 2 Diabetes Patients in Benin, Africa
A study testing A culturally tailored medical nutrition therapy in people with Type 2 Diabetes, run by University of Arizona at 1 site in Benin.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- A culturally tailored medical nutrition therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBenin
- Study dates
- 8 Sep 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
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.
Read the 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 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.
- Conditions
- Type 2 Diabetes
- Being tested
- A culturally tailored medical nutrition therapy
- Keywords
- Type 2 Diabetes, Cultural Adaptation, Medical Nutrition Therapy, Dietary Adherence, Africa
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A culturally tailored medical nutrition therapyBehavioural
This MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education.
| Study group | Role | What they receive |
|---|---|---|
| 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 a workbook and an Eating Plan based on the 4-A framework of food security. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: HbA1c will be assessed at baseline, 3, 6, and 12 months.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Waist circumference will be assessed at baseline, 3, 6, and 12 months.
Blood pressure
The blood pressure will be measured with a sphygmomanometer.
Measured: 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).
Measured: 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).
Measured: Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start8 Sep 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Halimatou Alaofe, University of Arizona
- Investigators
- Waliou Amoussa-Hounkpatin, PhD, Principal investigator, Université d'Abomey-CalaviEdward Bedric, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145684
- Sponsor's protocol ID
- STUDY00002233
- Other IDs
- K01TW012422
- Acronym
- OSanDiaBé
- Status last verified
- May 2026
- First submitted
- 11 Aug 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained from this study may be shared with qualified researchers who have an academic interest in type 2 diabetes. Any data or samples provided will be coded and will not include any personal health information (PHI). Before sharing the data, the request must receive approval, and all necessary agreements (such as a material transfer agreement) must be in place.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Culturally Tailored Medical Nutrition Therapy for African Patients With Type 2 Diabetes: The Objectif Santé Diabète Benin (OSanDiaBé) Trial
- ClinicalTrials.gov ID
- NCT07145684
- Acronym / sponsor ID
- OSanDiaBé / STUDY00002233
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Cultural Adaptation, Medical Nutrition Therapy, Dietary Adherence, Africa
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSanDiaBé intervention | Experimental | Behavioral: A culturally tailored medical nutrition therapyThe 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 a workbook and an Eating Plan based on the 4-A framework of food security. |
| 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A culturally tailored medical nutrition therapyThis MNT intervention combines evidence-based menu plans based on the 4A framework of food security with individual nutrition counseling and group diabetes education. | Behavioural | OSanDiaBé intervention |
Primary outcome
Hemoglobin A1C (HbA1C)
Time frame: 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.
8 secondary outcomes
Adherence to dietary recommendations
Time frame: Dietary adherence will be assessed at baseline, 3, 6, and 12 months.
Weight
Time frame: Weight will be assessed at baseline, 3, 6, and 12 months.
Height
Time frame: Height will be assessed at baseline, 3, 6, and 12 months.
Body mass index
Time frame: BMI will be assessed at baseline, 3, 6, and 12 months.
Waist circumference
Time frame: Waist circumference will be assessed at baseline, 3, 6, and 12 months.
Blood pressure
Time frame: Blood pressure will be assessed at baseline, 3, 6, and 12 months.
Lipid profile
Time frame: Lipid profile will be assessed at baseline, 3, 6, and 12 months.
Behavioral outcomes
Time frame: Behavioral outcomes will be assessed at baseline, 3, 6, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. Data obtained from this study may be shared with qualified researchers who have an academic interest in type 2 diabetes. Any data or samples provided will be coded and will not include any personal health information (PHI). Before sharing the data, the request must receive approval, and all necessary agreements (such as a material transfer agreement) must be in place.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waliou Amoussa-Hounkpatin, PhD principal investigator
Université d'Abomey-Calavi
Edward Bedric, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A culturally tailored medical nutrition therapy in people with Type 2 Diabetes, run by University of Arizona at 1 site in Benin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Benin. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (HbA1C) (time frame: HbA1c will be assessed at baseline, 3, 6, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.