A Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total caloric intake
研究概览
简要总结
The objective of this project is to determine the feasibility of introducing CGMs to adolescent patients with obesity and pre-diabetes (Hemoglobin A1C: HbA1C between 5.7-6.5%) to determine whether their eating habits and subsequent glucose profiles are modified by the timely awareness of glucose excursions above the diabetes threshold of 200 mg/dl.
详细描述
Building on prior UF protocols and national ORBIT-model guidance for early-phase behavioral-treatment development, this study represents a Phase I/IIa feasibility and signal-of-efficacy trial. The study is a comparison of food choice and decision making between a NO CGM group and a Open-label CGM group. Several bio markers are used to determine the consequences of nutritional choices. This information is used in nutritional counselling sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 13-17 years.
- •BMI ≥ 95 percentile
- •BMI >85th and BMI < 95th percentile for age and sex (CDC growth charts) if the risk factors below are present: Family history of type 2 diabetes in first or second degree relative:
- •Race/ethnicity Native American, African American, Latino, Asian American, Pacific Islander
- •Signs of insulin resistance or conditions associated with insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight)
- •Maternal history of diabetes or gestational diabetes mellitus (GDM) during the child's gestation
- •Receiving care through HCN for pediatric or family medicine clinics.
- •No structured nutritional intervention in the past 3 months.
- •Parent/guardian able to provide informed consent and child able to assent.
- •Family has access to a smartphone or is willing to use a study-provided device for CGM viewing and communication.
- •Willingness to comply with study visits, CGM wear, and laboratory testing.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation:
- •Diabetes by history or HbA1c ≥ 6.5 % in the medical record or at screening.
- •Unable or unwilling to provide consent or participate fully in study activities.
- •Conditions predisposing to diabetes or altering normal pubertal development.
- •Current or planned use of medications affecting glucose dynamics, including:
- •o Insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, or other glucose-lowering or weight-loss medications within 6 weeks prior to enrollment or planned during the study period.
- •Known syndromic or monogenic obesity.
- •Blood disorders that impact HbA1c interpretation (e.g., anemia, and hemoglobin variants).
- •Major systemic organ disease (renal, hepatic, or cardiac).
- •History or planned bariatric surgery.
- •Current pregnancy or plans for pregnancy during the study.
- •Use or planned use of GnRH agonists, estrogen, or testosterone.
- •Non-English- or non-Spanish-speaking individuals, as validated questionnaires are available only in these languages.
结局指标
主要结局
Total caloric intake
时间窗: Baseline; 3 Months
Total caloric intake as assessed from a validated 24-hour Dietary Recall
Total grams of carbohydrates from sugar
时间窗: Baseline; 3 Months
Total grams of carbohydrates from sugar in food as assessed from a validated 24-hour Dietary Recall
次要结局
- 5-point Likert scale Questionnaire of child food understanding(Baseline; 3 Months)
- Metabolic outcome - Difference in Hba1c(Baseline; 3 Months)
- Metabolic outcome - Difference in BMI Z score(Baseline; 3 Months)
- Metabolic outcome - Difference in complete metabolic panel(Baseline; 3 Months)
- Differences in Fitness assessment scores(Baseline; 3 Months)