Pre-diabetesEIDNCT07443995
Evidence-based Intervention for Diabetes Prevention
A study testing Adapted diabetes prevention program, App based support and Patient education materials in people with Pre-diabetes and Lifestyle Risk Reduction, run by New York University at 1 site in United Arab Emirates.
Trial summary
The goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-diabetes, Lifestyle Risk Reduction, Diet Prevention of Metabolic Diseases
- What is being tested?
- Adapted diabetes prevention program, App based support and Patient education materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Apr 2026to Aug 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 18 years or older
- Diabetes risk score > 5
- BMI >=25kg/m^2
- Arabic or English speaking
- Able to read and write in Arabic or English
- Access to a smartphone
- Provide informed consent
Who cannot join
- Prevalent diabetes
- Prior participation in a diabetes prevention program
- Taking FDA-approved weight loss medications
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site
New York University Abu Dhabi
Abu Dhabi, 129188
Andrea L Leinberger-Jabari, MPH, 971 2 628 4206, aj100@nyu.edu
Youssef Idaghdour, PhD, 971 2 628 5332, yi3@nyu.edu
About this study
The goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE.
The investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.
The primary feasibility measure is acceptability, as measured by intervention session attendance. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi, where study staff will assess weight, hemoglobin A1c, diet, and physical activity.
Read the detailed description
Study Purpose This feasibility study will investigate the effectiveness of an individual automated plus group-based telehealth arm facilitated by a health coach. The long-term goal is to develop strategies to decrease the incidence of diabetes within the UAE.
Study Hypotheses Participants will attend >50% of intervention sessions and will experience a clinically significant reduction in weight of 3.5% after 12 weeks. Predictors of intervention acceptability will include age, gender, and baseline body mass index.
Study Objectives Study investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.
The primary feasibility measure is acceptability. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi where study staff will assess weight, hemoglobin A1c, diet, and physical activity.
This project will accomplish the following specific aims:
Aim 1: Identify predictors associated with intervention adherence.
Predictors of adherence to intervention arms will include age, gender, and baseline body mass index.
Predictors of adherence to intervention arms will include age, gender, and baseline body mass index. Investigators will also evaluate the acceptability of the intervention using surveys and semi-structured interviews.
Aim 2: Assess the effectiveness of the intervention on key clinical outcomes.
Hypothesis 2: Participants will experience a clinically significant reduction in weight of 3.5% after 12 weeks. In-person outcome assessment visits to measure weight and glycemia at baseline, and 3 months among all participants will be conducted.
- Being tested
- Adapted diabetes prevention program, App based support, Patient education materials
- Keywords
- pre-diabetes, behavioral intervention, diet, physical activity
- Medical subject headings
- Glucose Intolerance, Risk Reduction Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted diabetes prevention programBehavioural
The intervention is based on the CDC Diabetes Prevention Program and has been adapted into a culturally appropriate intervention in an Arab context. The program has been condensed into 12 sessions with an additional session that addresses lifestyle factors during Ramadan. Each session covers a different topic related to diet, physical activity, sleep, and stress management. Additionally, the intervention includes written materials to help participants develop lifestyle goals and encourages them to seek social support. There are a series of 12 videos in Arabic and English that support the information delivered in the group sessions.
In addition to the group sessions, participants will have access to the automated app and education materials.
App based supportBehavioural
This intervention will provide educational videos that have been culturally adapted to the Arab context and additional automated supports for lifestyle modification. Study participants will be provided with access to an app that they will be encouraged to engage with on a regular basis. The app will provide basic diet, physical activity, and lifestyle support to prevent diabetes. Participants will also be able to track activity, diet, and receive feedback on their personal weight, diet habits, and activity levels.
Patient education materialsBehavioural
Participants will be provided written or web-based diabetes prevention materials. These materials will provide basic tips on diet, physical activity and other lifestyle factors.
| Study group | Role | What they receive |
|---|---|---|
| Group facilitated behavioral counseling arm | Experimental | Participants in this arm will participate in 12 group counseling sessions online. Sessions will be weekly. The 12 sessions are adapted from the CDC DPP program and will deliver culturally appropriate information on diet and activity to prevent diabetes. The participants will have access to video content and will also receive written curricular materials. All materials are culturally adapted and translated into Arabic. The participants will also have access to a local smartphone app to assist with goal setting, logging physical activity and food intake, as well as receiving additional personalized health recommendations. Receives: Behavioral: Adapted diabetes prevention program; Behavioral: App based support; Behavioral: Patient education materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention acceptability based on the proportion of sessions attended
Acceptability of the intervention will be measured by the number (%) of intervention sessions attended. Each participant will be offered 12 intervention sessions, and the acceptability of the intervention will be measured by the proportion of sessions attended (# sessions attended/ 12).
Measured: 3 months (post intervention)
Secondary outcomes (1)
Changes in glycemia
Changes in HbA1c at 3 months post baseline.
Measured: 0 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeannette Beasley, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443995
- Sponsor's protocol ID
- ADHRTC-2025-195/HRPP-2023-238
- Acronym
- EID
- Status last verified
- Oct 2025
- First submitted
- 20 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Local data privacy laws may prohibit the public sharing of individual-level participant data. We will share data upon a reasonable request to the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Intervention for Diabetes Prevention
- ClinicalTrials.gov ID
- NCT07443995
- Acronym / sponsor ID
- EID / ADHRTC-2025-195/HRPP-2023-238
- Keywords
- pre-diabetes, behavioral intervention, diet, physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 2 Mar 2026 (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 goal of this behavioral intervention trial is to develop strategies to decrease the incidence of diabetes within the UAE. The investigators will investigate the effectiveness of a group-based telehealth intervention facilitated by a health coach in adults at risk for developing diabetes who live in the UAE.
The investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.
The primary feasibility measure is acceptability, as measured by intervention session attendance. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi, where study staff will assess weight, hemoglobin A1c, diet, and physical activity.
Detailed description
Study Purpose This feasibility study will investigate the effectiveness of an individual automated plus group-based telehealth arm facilitated by a health coach. The long-term goal is to develop strategies to decrease the incidence of diabetes within the UAE.
Study Hypotheses Participants will attend >50% of intervention sessions and will experience a clinically significant reduction in weight of 3.5% after 12 weeks. Predictors of intervention acceptability will include age, gender, and baseline body mass index.
Study Objectives Study investigators will conduct a single-arm feasibility trial of the Evidence-based Intervention for Diabetes prevention among thirty adults with prediabetes. All participants will receive 12 weekly virtual intervention sessions over the course of three months, facilitated by a trained DPP lifestyle coach who is from the same cultural community and can deliver the material in either Arabic or English.
The primary feasibility measure is acceptability. Other outcome assessments will be conducted at baseline and three months at NYU Abu Dhabi where study staff will assess weight, hemoglobin A1c, diet, and physical activity.
This project will accomplish the following specific aims:
Aim 1: Identify predictors associated with intervention adherence.
Predictors of adherence to intervention arms will include age, gender, and baseline body mass index.
Predictors of adherence to intervention arms will include age, gender, and baseline body mass index. Investigators will also evaluate the acceptability of the intervention using surveys and semi-structured interviews.
Aim 2: Assess the effectiveness of the intervention on key clinical outcomes.
Hypothesis 2: Participants will experience a clinically significant reduction in weight of 3.5% after 12 weeks. In-person outcome assessment visits to measure weight and glycemia at baseline, and 3 months among all participants will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group facilitated behavioral counseling arm | Experimental | Behavioral: Adapted diabetes prevention program, Behavioral: App based support, Behavioral: Patient education materialsParticipants in this arm will participate in 12 group counseling sessions online. Sessions will be weekly. The 12 sessions are adapted from the CDC DPP program and will deliver culturally appropriate information on diet and activity to prevent diabetes. The participants will have access to video content and will also receive written curricular materials. All materials are culturally adapted and translated into Arabic. The participants will also have access to a local smartphone app to assist with goal setting, logging physical activity and food intake, as well as receiving additional personalized health recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women 18 years or older
- Diabetes risk score > 5
- BMI >=25kg/m^2
- Arabic or English speaking
- Able to read and write in Arabic or English
Key exclusion criteria (4 listed)
- Prevalent diabetes
- Prior participation in a diabetes prevention program
- Taking FDA-approved weight loss medications
- Pregnant or lactating
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 |
|---|---|---|
| Adapted diabetes prevention programThe intervention is based on the CDC Diabetes Prevention Program and has been adapted into a culturally appropriate intervention in an Arab context. The program has been condensed into 12 sessions with an additional session that addresses lifestyle factors during Ramadan. Each session covers a different topic related to diet, physical activity, sleep, and stress management. Additionally, the intervention includes written materials to help participants develop lifestyle goals and encourages them to seek social support. There are a series of 12 videos in Arabic and English that support the information delivered in the group sessions. In addition to the group sessions, participants will have access to the automated app and education materials. | Behavioural | Group facilitated behavioral counseling arm |
| App based supportThis intervention will provide educational videos that have been culturally adapted to the Arab context and additional automated supports for lifestyle modification. Study participants will be provided with access to an app that they will be encouraged to engage with on a regular basis. The app will provide basic diet, physical activity, and lifestyle support to prevent diabetes. Participants will also be able to track activity, diet, and receive feedback on their personal weight, diet habits, and activity levels. | Behavioural | Group facilitated behavioral counseling arm |
| Patient education materialsParticipants will be provided written or web-based diabetes prevention materials. These materials will provide basic tips on diet, physical activity and other lifestyle factors. | Behavioural | Group facilitated behavioral counseling arm |
Primary outcome
Intervention acceptability based on the proportion of sessions attended
Time frame: 3 months (post intervention)
Acceptability of the intervention will be measured by the number (%) of intervention sessions attended. Each participant will be offered 12 intervention sessions, and the acceptability of the intervention will be measured by the proportion of sessions attended (# sessions attended/ 12).
1 secondary outcome
Changes in glycemia
Time frame: 0 and 3 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 2 Mar 2026.
- Individual participant dataSharing planned: No. Local data privacy laws may prohibit the public sharing of individual-level participant data. We will share data upon a reasonable request to the study PI.
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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.
Jeannette Beasley, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted diabetes prevention program, App based support and Patient education materials in people with Pre-diabetes and Lifestyle Risk Reduction, run by New York University at 1 site in United Arab Emirates.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Mar 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 United Arab Emirates. 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?
Contact Jeannette Beasley, PhD (646-501-4681, jbeasley@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability based on the proportion of sessions attended (time frame: 3 months (post intervention)). 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 2 Mar 2026.