Guys/Girls Opt for Activities for Life Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 935
- 试验地点
- 4
- 主要终点
- Change from Baseline Percent (%) Body Fat (adolescents) to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U])
研究概览
简要总结
In this 2-phase trial (R61/R33), we propose Guys/Girls Opt for Activities for Life (GOAL). Guided by Self-Determination Theory and the Information-Motivation-Behavioral Skills Model, GOAL will target the school and home environment to increase young adolescents' physical activity (PA) and healthy eating by increasing important factors at the individual-level: motivation and self-efficacy; and socioenvironmental-level: social support. The 4-month (16-wk) GOAL intervention has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 weeks due to no club during 3 school break weeks) for boys and girls to engage in PA and healthy eating/cooking activities; (2) Three parent-adolescent meetings (1st meeting at each school, which is also conducted synchronously via Zoom to increase convenience for parents who are not able to meet in-person at the school for various reasons; 2nd and 3rd meetings video-recorded and delivered asynchronously to accommodate and meet the needs of busy parents who have varying schedules due to work, home, and other responsibilities): to empower parents to assist adolescents with PA and healthy eating/cooking; and (3) GOAL social networking website: private website (already developed) for parents to learn about healthy eating and PA, network with other parents, and share with each other about how they helped their adolescent(s) increase PA and diet quality each week.
The purpose of this individual randomized controlled trial (unit of assignment is adolescent) is to evaluate the effect of GOAL on decreasing cardiovascular disease risk factors (high percent body fat, overweight/obesity, low cardiovascular fitness), improving quality of life; and increasing motivation, self-efficacy, and social support to increase moderate-to-vigorous PA and diet quality among adolescents (5th-8th grade) throughout the state of Michigan. All interested adolescents who meet eligibility criteria and have parental consent will be included. We are including all interested students and not only those who have a high BMI (e.g., BMI z-score ≥0 [≥50th percentile]), in order to avoid social stigma(s) discouraging adolescents from participating. Adolescents in each of 14 schools total will be randomly assigned to the intervention or control (usual school activities) condition. The plan is to include at least n=33 intervention and n=30 control adolescents in each school every year for 3 years of the R33 Phase. On average, we will include at least 63 adolescents per school (at least 31-32 boys and 31-32 girls) and one parent per adolescent will be enrolled, bringing our total sample size to at least 882 dyads total (882 adolescents and one parent per adolescent).
详细描述
The Guys/Girls Opt for Activities for Life (GOAL) Trial will use an individual randomized controlled trial (IRCT) design. On average, we will include at least 63 adolescents (at least 31-32 boys and 31-32 girls) in each of 14 schools. Adolescents in each school are randomly assigned by our senior biostatistician to either the 16-wk GOAL intervention or a routine school offerings control condition. One parent/guardian (for brevity sake, referred to as parent) per adolescent will also participate as a support person. During each of the 3 intervention yrs (Yrs 3, 4, & 5), the cohort of adolescents and parents participating will differ (Yr 3 Cohort: 4 schools; Yrs 4 & 5 Cohorts: 5 different schools in each year). Data will be collected at 3 time periods from each cohort: 1) pre-intervention/baseline (Wk 0); 2) immediately post-intervention (after 4 months), and 3) 9-month post-intervention follow up (F/U; 13 months post-baseline). We will include, on average, at least 63 adolescents in 5th-8th grade (10-14 yrs old) per school in low-income urban communities in Michigan and one parent per adolescent as a support person. Approximately half of the adolescent participants in each school will be boys, and half will be girls.
R61 Phase (1 year, but extended to 2 years from 2019-2021 due to COVID-19):
Human Subjects approval will be granted from Michigan State University (MSU) Institutional Review Board prior to recruitment. Each school administrator will be asked to identify a program champion to assist researchers during the study.
The PI and Project Manager (PM) will work with the University of Michigan Center for Health Communications Research (CHCR) to make minor refinements to our already developed GOAL social networking website (designed to assist parents in helping their adolescents increase physical activity [PA] and healthy eating) and integrate it into an administrative console with databases for tracking and monitoring day-to-day study operations.
Prior to recruitment, data collection, and the intervention start in fall of Yr 3, the protocol was provided to all permanent research staff for review within the first month of their hire date and prior to any contact with participants.
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
- Single (Outcomes Assessor)
盲法说明
After baseline data collection, adolescents and parents at each school will be told whether they will receive the GOAL intervention or not. We see no way to blind participants as to which group they are in. Adolescents, parents, principals, school staff, interventionists, and process evaluators will not be told about study aims and hypotheses. Process evaluators (trained by Co-I Pfeiffer) will be independent and not involved in other study areas. Data collectors and biostatistician will not be aware of any adolescent's or parent's (the dyad's) randomization status. Data collectors and interventionists are in separate teams and have separate training and meetings.
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescent inclusion criteria are:
- •5th-8th grade boys and girls (ages 10-14)
- •available and willing to participate in GOAL, including the school club conducted after school 2 days/week for 13 weeks (not during 3 weeks of school breaks)
- •available for follow up (9 months after intervention ends)
- •agree to random assignment
- •able to read, understand, and speak English or have an interpreter
- •able to identify one parent/guardian who is willing and able to serve as a support person and complete study activities
排除标准
- •mental or physical health condition precluding safe MVPA
- •taking medications that alter appetite, weight, or growth.
- •Parent/guardian inclusion criteria are:
- •have male or female student in 5th-8th grade
- •≥18 yrs. of age
- •available and willing to participate in GOAL
- •able to read, understand, and speak English or have an interpreter
- •have Internet access and device for accessing website (e.g., mobile phone ["smart" phone], tablet, computer) and a cellphone which can receive text messages.
- •mentally and physically able to serve as a support person.
- •Parent/guardian exclusion criteria are:
- •mental or physical health condition precluding engagement in safe MVPA and healthy meal preparation with adolescent
- •not interested in using a private social networking website, similar in design to Facebook, to respond to challenges
- •not interested in learning to post.
研究组 & 干预措施
Guys/Girls Opt for Activities for Life Intervention (GOAL)
Receives the 4 month (16-wk) GOAL intervention, which has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 wks due to no club during 3 school break wks) for boys and girls to engage in physical activity and healthy eating and cooking activities; (2) Three parent-adolescent meetings (1st meeting at each school with parents and adolescents [Zoom option if needed]; 2nd and 3rd meetings delivered virtually for parents): to empower parents to assist adolescents with physical activity and healthy eating and cooking; and (3) GOAL social networking website: private website for parents to share with each other how they helped their adolescent increase physical activity and diet quality each week.
干预措施: Guys/Girls Opt for Activities for Life (GOAL) (Behavioral)
Control
Received usual school activities.
结局指标
主要结局
Change from Baseline Percent (%) Body Fat (adolescents) to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U])
时间窗: baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline)
Bioelectric impedance analysis (BIA) will be used to estimate % body fat. The manufacturer's protocol will be followed (RJL Quantum \[IV\] BIA Systems, Clinton Township, MI). Testing will be conducted behind a privacy screen by 2 data collectors. Boys and girls will void before testing. Measures will be taken with electrodes: 1 placed on the hand, wrist, foot, and ankle; all on right side of body. Percent (%) body fat will be measured to nearest .1%. Two measurements will be taken. Results are available immediately from the RJL software program. If the 2 measurements differ by \>1%, a 3rd measurement must be taken.
次要结局
- Change in Body Mass Index (BMI) and Overweight/Obesity Percentage from baseline to 4 months (post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U]).(baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline))
- Change from Baseline Cardiovascular (CV) Fitness (adolescents) to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Minutes of Moderate-to-Vigorous Physical Activity (MVPA; adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Quality of Life (adolescents) from baseline to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U]).(baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline))
- Change in Diet Quality (e.g., healthy eating index, servings of fruit and vegetables, sweetened beverage consumption; adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Physical Activity Self-Efficacy (adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Social Support for Physical Activity (adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Motivation for Physical Activity (adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Self-Efficacy for Healthy Eating (adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Baseline Social Support for Healthy Eating (adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Motivation for Healthy Eating (adolescents) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Family Nutrition and Physical Activity (exploratory aim; parents/guardians) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Minutes of Moderate-to-Vigorous Physical Activity (MVPA; exploratory aim; parents/guardians) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Diet Quality (exploratory aim; parents/guardians) from baseline to 4 months (immediate post-intervention)(baseline (0 months) and immediately post-intervention (after 4 months))
- Change in Body Mass Index (BMI; exploratory aim; parents/guardians) from baseline to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month post-intervention follow up [F/U])(baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline))
研究者
Lorraine Robbins
Professor
Michigan State University