Evidence-based Intervention for Diabetes Prevention

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Adapted diabetes prevention program
  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
• Поведенческое App based support
  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, a
• Поведенческое Patient education materials
  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.

Первичные конечные точки

• Intervention acceptability based on the proportion of sessions attended [Срок оценки: 3 months (post intervention)]

Вторичные конечные точки (1)

• Changes in glycemia [Срок оценки: 0 and 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Prevalent diabetes
• Prior participation in a diabetes prevention program
• Taking FDA-approved weight loss medications
• Pregnant or lactating

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

ОАЭ · 1 центр

• New York University Abu Dhabi — Abu Dhabi

Идентификаторы

NCT: NCT07443995 · ADHRTC-2025-195/HRPP-2023-238

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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