Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07443995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence-based Intervention for Diabetes Prevention
Sponsor:
New York University
Organization:
Study Overview
Official Title:
Evidence-based Intervention for Diabetes Prevention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EID
Brief 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.
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.
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: