Mobile Regulation of Craving Training (mROC-T) to Improve Dietary Intake in Rural Adolescent Girls
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Healthy eating index (HEI)
研究概览
简要总结
The goal of this clinical trial is to test if a regulation of craving training intervention in the form of a mobile phone app can increase fruit and vegetable intake in adolescent girls ages 14-18 years of age. The main questions it aims to answer are:
- What is the effect of a mobile app version of the regulation of craving training intervention on healthy eating index scores over one year?
- What is the effect of a mobile app version of the regulation of craving training intervention on body mass index, waist circumference, and blood glucose over one year? Researchers will compare the active regulation of craving training arm to a control fun food fact arm to see if the regulation of craving training improves HEI scores, BMI, and blood glucose over a year. Participants will be asked to play the regulation of craving training mobile app twice a week for a year.
详细描述
Randomization: Participants will be randomized to either an active mROC-T group (mROC-T+ or mROC-Tc) or a craving rating only (CRO) control group stratified by race/ethnicity and BMI%. We will use urn randomization for participant assignment.
Baseline and 1-year follow up in-person visit measures Oral glucose tolerance test (OGTT): We will use a standard NHANES oral glucose tolerance test (OGTT) to assess the participants' glucose disposal. Participants will be fasted for at least eight hours. A fasted blood draw will be performed via finger stick. We will analyze glucose concentration using the HemoCue Glucose 201 analyzer and HbA1c using Abbott Afinion™ HbA1c analyzer. The participants will then drink a glucose bolus dosed at 1.75g glucose/kg body weight. Subsequent samples will be taken at 30, 60, 90, and 120-minutes. During which time the participant will play the mROC-T game and record their diet recall of the previous day. Participants will complete the puberty development scale (PDS), which has shown good epidemiological validity and is a suitable control variable. We will also measure height, weight, waist circumference using NHANES protocols. We will measure trait food craving using the Food Craving Questionnaire (trait).
Overall model for aims 1 and 2: For both aims we will use mixed-effect models (MEM, allows us to model random intercepts for participants by location and random slopes for the intervention by time) and estimated marginal means (EMM, corrects for potential imbalanced data). Covariates (COV) are baseline PDS, FCQT, race/ethnicity, and age. Intervention is a categorical variable representing intervention group.
Aim1 assesses the effect of the intervention over 1 year compared to baseline in the mROC-T and CRO groups on HEI calculated monthly. Fixed effects will be considered significant at p≤ 0.02. HEI1-year ~ Intervention*x(time) + HEIbaseline + COV; where x() is the time function (see note below)
Time note: we plan on modeling time using linear, power polynomials (square and cubic), and logistic functions. We will compare the different time powered models using ANOVAs and consider p ≤ 0.05 a significant difference between models, and Akaike information criterion (AIC) to assess model parsimony.
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
- 15 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biologically female
- •Female gender
- •Between the ages of 15y and 18y
排除标准
- •Biologically male
- •Self-identify as male
- •BMI percentile (for age and sex) < 5th%
- •Diagnosis from a medical profession of any of the following conditions, syndromes, diseases that may affect growth, glucose metabolism, blood clotting, cognitive development*:
- •Any form of or history of cancer
- •Any form of diabetes (type I, II, insipidus)
- •Precocious puberty
- •Crohn's disease
- •Congenital heart defect
- •Cystic fibrosis
- •Cerebral palsy
- •Anorexia nervosa
- •Bulimia nervosa
- •Active infection
- •Hemophilia
- •Hydrocephalus
- •intestinal atresia
- •Jeune syndrome
- •Klippel-Trénaunay syndrome
- •Legg-Calvé-Perthes
- •Long QT syndrome
- •Muenke syndrome
- •Myelomeningocele
- •Necrotizing Enterocolitis
- •Neutropenia
- •Non-alcholoic fatty liver diease
- •Pfeiffer Syndrome
- •Saethre-Chotzen syndrome
- •Shwachman-Diamond syndrome
- •Spinal muscular atrophy
- •Sturge-Weber syndrome
- •Ulcerative Colitis
- •von Willebrand disease
- •Pancreatitis
- •Hurler syndrome
- •Niemann-Pick disease
- •Tay-Sachs disease
- •Gaucher disease
- •Krabbe disease
- •Zellweger syndrome
- •Wilson disease
- •Brachial Plexus Palsy
- •Brain Abscess or Spinal Abscess
- •Coarctation of the Aorta
- •Aortic stenosis
- •Ventricular septal defect
- •Patent ductus arteriosus or mitral valve abnormalities
- •Congenital Adrenal Hyperplasia
- •Craniofacial Microsomia
- •Duchenne Muscular Dystrophy
- 另有 10 项未显示
结局指标
主要结局
Healthy eating index (HEI)
时间窗: 1 year
Participants will provide diet recalls twice per month. The participants will complete the diet recalls using the Automated Self Administered 24 hour recall (ASA-24) platform. The ASA-24 computes the necessary variables to calculate the healthy eating index (HEI). HEI is a measure of overall diet quality according to the Dietary Guidelines for Americans and is scored from 0-100 (100 being the best possible diet). HEI scores will be calculated per month (mean of diet recalls per person) using the most recent HEI scoring algorithm as recommended for intervention studies.
次要结局
- Body mass index(1 year)
- Blood sugar(1 year)
研究者
Grace Elisabeth Shearrer
Assistant Professor
University of Wyoming