Evidence-based Intervention for Diabetes Prevention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intervention acceptability based on the proportion of sessions attended
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prevalent diabetes
- •Prior participation in a diabetes prevention program
- •Taking FDA-approved weight loss medications
- •Pregnant or lactating
研究组 & 干预措施
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.
干预措施: Adapted diabetes prevention program (Behavioral)
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.
干预措施: App based support (Behavioral)
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.
干预措施: Patient education materials (Behavioral)
结局指标
主要结局
Intervention acceptability based on the proportion of sessions attended
时间窗: 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).
次要结局
- Changes in glycemia(0 and 3 months)