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NCT Number: NCT07443995

Evidence-based Intervention for Diabetes Prevention

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.

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Key information

Conditions

Pre-diabetes Behavior Diet Prevention of Metabolic Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Lifestyle Risk Reduction Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Risk Reduction Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted diabetes prevention program

Behavioral

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 support

Behavioral

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 materials

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Changes in glycemia

    Time frame: 0 and 3 months

    Changes in HbA1c at 3 months post baseline.

Other outcomes

  1. Weight loss

    Time frame: 0 and 3 months

    Mean weight loss at 3 months post baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeannette Beasley, PhD

CONTACT

[email protected]

646-501-4681

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Acronym: EID

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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