Glucose-Guided Eating to Reduce Chronic Disease Risk: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- GGE adherence
研究概览
简要总结
This is a single center, parallel-arm randomized controlled pilot study that aims to examine the feasibility and acceptability of the glucose-guided eating (GGE) mobile app and intervention in two populations at risk of chronic disease (postmenopausal women with prediabetes and AYA cancer survivors).
详细描述
The primary objectives of the study are to (1) test the feasibility and acceptability of the GGE intervention and companion GGE mobile app and (2) quantify the preliminary effect of GGE on 12-week changes in insulin resistance (IR) and body weight.
The secondary objectives of the study are to (1) collect preliminary data on hypothesized mechanisms linking GGE to IR and (2) explore the durability of intervention effects on 24-week changes in body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Self-reported height and weight that is consistent with a BMI ≥ 27 kg/m2
- •Willing to use a continuous glucose monitor
- •Own smartphone that is compatible with Dexcom CGM.
- •Willingness to commute to GUMC for in-person study visits
- •No active cancer (except for nonmelanoma skin cancer)
- •Less than 5 lbs. weight change in previous 3 months
- •Proficient in speaking and reading English
- •Postmenopausal women with pre-diabetes:
- •Age 18 years and older
- •Diagnosed as having prediabetes.
- •HbA1c (within 3 months) between 5.7% and 6.4%
- •Postmenopausal (defined as reporting no menstrual period for ≥1 year or a reported history of a total abdominal hysterectomy with oophorectomy)
- •AYA cancer survivors:
- •Current age 21-39 years
- •Previously diagnosed with cancer, with all cancer-related diagnosis chemotherapy and/or radiation completed at least 6 months previously
排除标准
- •Unable or unwilling to provide informed consent
- •Clinical history of type 1 or type 2 diabetes
- •Currently receiving anti-diabetics (e.g., insulin, GLP1), oral hypoglycemic agent (e.g., metformin), oral corticosteroids, oral glucocorticoids, beta blockers, hydroxyurea, atypical antipsychotic agents (i.e., Olanzapine, Aripiprazole) or systemic progestin-only contraceptives
- •Current or past history of an eating disorder
- •Self-identify as an overnight eater (defined as eating main meals between 9pm-5am)
- •Have any contraindications for CGM, including: severe allergy to surgical adhesive, being on dialysis, receiving diathermy treatment, or scheduled CT scan or MRI during wear period
- •Growth hormone deficiency, hypoadrenal function, or hypopituitary function
结局指标
主要结局
GGE adherence
时间窗: Weeks 1-4
GGE adherence will be quantified as percent of reported eating events occurring at or below personalized glucose thresholds/personalized average fasting glucose levels that is collected using the GGE app (collected from participants randomized to the GGE intervention only-during use of the GGE app only).
Population-specific accrual
时间窗: Week 0
Population-specific accrual will reflect rates of study enrollment and will be defined as number of participants consented to the number of individuals who are determined to be eligible.
GGE app usability
时间窗: Week 12
The app usability will be assessed using the 10-item System Usability Scale. SUS scores have a range of 0 to 100 with 100 representing greatest usability.
Population-specific retention rates
时间窗: Week 12
Population-specific retention rates will reflect the proportion of enrolled participants who complete the study.
GGE intervention acceptability
时间窗: Week 12
GGE intervention acceptability will be assessed with a study specific survey (collected from participants randomized to the GGE intervention only).
次要结局
- Changes in the soluble receptor for advanced glycation end-products (sRAGE)(Weeks 1-12)
- Changes in glycemic variability(Weeks 1-12)
- Changes in body weight(Weeks 0-12 and Weeks 12-24)
- Changes in insulin resistance (HOMA-IR)(Weeks 1-12)
- Changes in oxidative stress(Weeks 1-12)