- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443995
Evidence-based Intervention for Diabetes Prevention (EID)
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeannette Beasley, PhD
- Phone Number: 646-501-4681
- Email: jbeasley@nyu.edu
Study Locations
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-
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Abu Dhabi, United Arab Emirates, 129188
- New York University Abu Dhabi
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Contact:
- Andrea L Leinberger-Jabari, MPH
- Phone Number: 971 2 628 4206
- Email: aj100@nyu.edu
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Contact:
- Youssef Idaghdour, PhD
- Phone Number: 971 2 628 5332
- Email: yi3@nyu.edu
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Principal Investigator:
- Youssef Idaghdour, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Prevalent diabetes
- Prior participation in a diabetes prevention program
- Taking FDA-approved weight loss medications
- Pregnant or lactating
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group facilitated behavioral counseling arm
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.
|
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.
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention acceptability based on the proportion of sessions attended
Time Frame: 3 months (post intervention)
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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).
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3 months (post intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in glycemia
Time Frame: 0 and 3 months
|
Changes in HbA1c at 3 months post baseline.
|
0 and 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight loss
Time Frame: 0 and 3 months
|
Mean weight loss at 3 months post baseline.
|
0 and 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeannette Beasley, PhD, New York University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADHRTC-2025-195/HRPP-2023-238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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