Activity, Adiposity, and Appetite in Adolescents 2 Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Appetite- Subjective
研究概览
简要总结
The objective of the study is to quantify the relationship between physical activity, metabolic function, and appetite in adolescents. To do this we will test our working hypothesis that high levels of regular moderate-to-vigorous physical activity (MVPA), as opposed to body weight status, results in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite. We will randomly assigning sedentary overweight/obese adolescents (N=44) to either a control or structured-exercise group for three months.
详细描述
he objective of the study is to quantify the relationship between physical activity, metabolic function, and appetite in adolescents. To do this we will test our working hypothesis that high levels of regular moderate-to-vigorous physical activity (MVPA), as opposed to body weight status, results in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite. We will randomly assigning sedentary overweight/obese adolescents (N=44) to either a control or structured-exercise group for three months.
Our study statistician Dr. Vincent Staggs will randomize participants after final eligibility is determined to either the newsletter control or exercise intervention, balanced by gender to ensure equal composition of males and females.
The sample size for Study 2 (Aim 2) was calculated based on data from our lab; a small pilot study with sedentary and active periods to test the feasibility of our laboratory protocols. Based on this preliminary data, which is similar to data in the existing literature, we estimate changes in appetite ratings (hunger) 11% from baseline, equating to effect sizes of 0.67, resulting in sample size calculations of N=35. Assuming a drop-out rate of 10% (n=4) during the three month intervention, which is typically observed in similar interventions conducted by Mentor Dr. Donnelly, final sample size is set at N=40.
Data analysis will be completed by the PI with assistance from the statistician Dr. Staggs and the mentorship team. For visual analog scale (VAS) appetite measures, which are assessed at multiple time points within a single measurement session, we will conduct analyses in two ways. First, we will conduct between group analyses using each of the seven individual assessments (e.g. 60 min post-meal) to see if the values differ by physical activity or body weight group. Second, we will also calculate area under the curve (AUC) for each variable of interest (e.g. hunger, ghrelin), and use that measure for the test of group differences. To address Aim 1, hypothesis 2, we will repeat the analyses described above and include insulin sensitivity as a covariate. To address Aim 2, hypothesis 3, we will conduct between group analyses of change over time using repeated measures ANOVA, using the same analysis techniques for the appetite variables as described in Aim 1 (single assessment and AUC), with insulin sensitivity included as a covariate.
Appetite is considered the primary outcome of Aim 1 and 2. Subjective assessment of hunger and palatability will be completed using self-rated visual analogue scales (VAS), with each scale consisting of a 10-cm long line separating statements such as ?not at all hungry? and ?extremely hungry?. Perceptions of dietary restraint, disinhibition, and hunger will be measured during each measurement session prior to the fixed meal using the Three Factor Eating Questionnaire (TFEQ). The Control of Eating Questionnaire (CEQ) will be used to assess hunger, fullness, cravings, the desire to eat certain types of foods, and the ability to resist urges to eat. Objective assessment of appetite will be completed using blood samples taken from an indwelling catheter, and analyzed for episodic regulation of the following fasting and satiety hormones: glucose, insulin, leptin, ghrelin, glucagon-like peptide 1 (GLP-1), and peptide YY (PYY). All samples will be mixed a standard preservative (400 ?L of 10,000 KIU aprotinin), centrifuged, the plasma divided into aliquots and stored in -80?C freezer until analysis using standard kits at an outside certified clinical laboratory.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tanner Stage III-V, as determined via self-assessment
- •Non-smoking
- •Not currently involved in any other research study
- •No meds that may alter metabolism
- •Sedentary (<60 min/day exercise)
- •Willing to participate in an exercise program
排除标准
- •BMI <5th percentile or >99th percentile for age and sex
- •Weight not stable
- •Restrained eater (>13 on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder.
- •Self-reported medical conditions (including, but not limited to, diabetes, Crohn's disease, etc.) that may affect adherence to the protocol, exercising safely, or alter metabolism
- •Taking medications know to affect metabolism (e.g. thyroid medication, β-blockers, or stimulants).
- •Gave birth in the past 12 months or <6 months post-lactation.
- •Active (>60 min/day exercise)
- •Not willing to participate in an exercise program
研究组 & 干预措施
Structured exercise
Adolescents randomized to the exercise will participate in a supervised structured exercise program (walking on a treadmill, cycling on a stationary bicycle, etc.) and expend an equivalent of 400 kcals/session (approximately 45-60 min/session) on three days/week. We will follow the protocol of Mentor Dr. Joseph Donnelly, with exercise prescriptions progressing from 150 kcal/session at intervention onset to reach the target exercise energy expenditure (EEEx) (400 kcal/session) at the end of month 3. EEEx will be assessed at baseline and monthly during the intervention to determine the duration of treadmill exercise required to achieve the EEEx goals. All supervised exercise will occur at the CCHLN on a treadmill with heart rate, speed, and grade monitored by an exercise specialist every five minutes.
干预措施: Aerobic exercise (Behavioral)
Newsletter control
Adolescents randomized to the newsletter control will receive with biweekly newsletters with "parenting tips, sample praise statements, and age-appropriate activities and recipes" identical to what has been used by others (Epstein et al., 2008), including existing group-based interventions with overweight/obese adolescents.
干预措施: Newsletter (Behavioral)
结局指标
主要结局
Appetite- Subjective
时间窗: 3 months
The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC) Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'. Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.
Appetite- Objective
时间窗: 3 months
he investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Appetite- Adjusted
时间窗: 3 months
The investigators will measure objective and subjective appetite responses as described above adjusted by insulin sensitivity (glucose infusion rate, mg/kg/min) as assessed in the euglycemic hyperinsulinemic clamp technique.
次要结局
未报告次要终点
研究者
Robin Shook
Associate Professor
Children's Mercy Hospital Kansas City
