Preliminary Examination of an Innovative mHealth-Based Dietary Fiber Intervention to Improve Outcomes in Young Adults With Prediabetes: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Retention of participants (as a measure of feasibility)
研究概览
简要总结
This is a single-arm feasibility trial to examine an mHealth intervention that combines high fiber education, home-delivered high fiber foods, and use of continuous glucose monitors.
详细描述
This is a single-arm trial enrolling young adults (aged 18-39) with prediabetes (based on hemoglobin A1c). Enrolled individuals will complete baseline data collection in person to assess insulin resistance (venous blood samples). Enrolled individuals will then complete a three-month fully-mHealth based intervention focused exclusively on promoting greater fiber intake. Participants will receive weekly home-delivered shipments of high fiber foods and wear a continuous glucose monitor at two time points as a form of biofeedback. After the three months, participants will return for repeat assessment of insulin resistance. After that repeat assessment, participants will do a one-month observation period using cell phone-based ecological momentary assessments.
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
盲法说明
Masking not possible as single arm
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-diabetes based on HbA1c
- •Young adult, aged 18-39 years
- •Reside near Tulsa metro area
- •Ability to access/use a compatible smartphone
- •Proficient in English
排除标准
- •Suspected eating disorder
- •Current glucagon-like peptide-1 receptor agonist use
- •Food allergies or intolerances
- •Currently pregnant or breastfeeding
研究组 & 干预措施
Fiber-focused intervention
Mobile phone delivered content about fiber (daily), continuous glucose monitors, and home delivered high fiber foods
干预措施: GO-FAR (Behavioral)
结局指标
主要结局
Retention of participants (as a measure of feasibility)
时间窗: Retention will be based on time retained in the study over a period of approximately 5 months (from enrollment to completion of follow-up data collection)
Percentage of enrolled participants who remain in the study throughout the intervention period
Recruitment (as a measure of intervention feasibility)
时间窗: Evaluated at the end of the project period (2 years in total)
Percentage of recruitment goal reached.
Acceptability (as a measure of feasibility)
时间窗: Measured at the end of the 3-month intervention
Participants will rate their perceived acceptability of the intervention using a 5-point Likert scale question ("How would you rate this study intervention as a whole?" rated as Poor, Fair, Good, Very Good, Excellent.
次要结局
- Glycemic control (hemoglobin A1c [HbA1c])(Baseline and after the intervention (3 months))
- Dietary fiber intake(Baseline, after-intervention (3-months), and after a 4-week observation period)
- Insulin resistance (Homeostatic Model Assessment of Insulin Resistance [HOMA-IR])(Baseline and after-intervention (3 months))