Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating (GOAL)
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|ClinicalTrials.gov Identifier: NCT04213014|
Recruitment Status : Suspended (Recruitment halted due to COVID19)
First Posted : December 30, 2019
Last Update Posted : May 29, 2020
|First Submitted Date ICMJE||December 20, 2019|
|First Posted Date ICMJE||December 30, 2019|
|Last Update Posted Date||May 29, 2020|
|Estimated Study Start Date ICMJE||September 30, 2020|
|Estimated Primary Completion Date||February 28, 2024 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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]) [ Time Frame: 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). A day before the test, a data collector will give a flyer to adolescents at school (to share with parents) and call parents by phone to inform them that their adolescents need to skip breakfast, avoid exercise, and drink only a small amount water if thirsty during the morning of the test. Testing, which will occur in the early morning, 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. Healthy breakfast will be offered after testing.
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating|
|Official Title ICMJE||Guys/Girls Opt for Activities for Life Trial|
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 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 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 (group meetings at each school): to empower parents to assist adolescents with physical activity and healthy eating and cooking; and (3) GOAL social networking website: private website (already developed) for parents to share with each other how they helped their adolescent increase physical activity and diet quality during a prior wk.
The purpose of this 5-yr group randomized trial (unit of assignment is school) 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 physical activity and diet quality among underserved adolescents (5th-7th grade) having body mass index z-score >0. Schools will be paired based on similar characteristics. Schools in each pair will be randomly assigned to GOAL (n=11) or usual school offerings control condition (n=11; N=22 schools total). Cohort 1 will include 3 pairs (Yr 2). Cohorts 2 and 3 will include 4 pairs (Yrs 3 & 4, respectively). Forty boys (n=20) and girls (n=20) and one parent per adolescent from each school will be enrolled (880 adolescents with their parent).
The Guys/Girls Opt for Activities for Life (GOAL) Study will use a group randomized trial (GRT) design and pair interested schools prior to randomization based similar characteristics. Our senior biostatistician will randomly select 11 pairs (22 schools) and randomize schools in each pair to either the 16-wk GOAL intervention or routine school offerings control condition so all adolescents and parents associated with a school are in the same condition. During each of the 3 intervention yrs (Yrs 2, 3, & 4), the cohort of adolescents and parents participating will differ (Yr 2 Cohort: 3 intervention & 3 control schools; Yr 3 Cohort: 4 intervention & 4 control schools: Yr 4 Cohort: 4 intervention & 4 control schools). 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 40 adolescents in 5th-7th grade (10-13 yrs old) per school in low-income urban communities in Michigan (20 boys; 20 girls) and one parent per adolescent as a support person.
R61 Phase (Yr 1; Months 1-12).
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 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 2, the PI and PM will conduct a 4-hour session on protocols for the research team. All recruiters, data collectors, interventionists will be trained.
R33 Phase (Yrs 2-5; Months 13-60).
In September (Yr 2), we will recruit 40 adolescents (20 boys; 20 girls) and 1 parent per adolescent who is willing to be a support person (40 dyads) from each of 6 schools paired based on similar characteristics and randomly selected by our biostatistician from 11 pairs total. At the beginning of each academic school yr, the PI, PM, and 2 racially diverse research assistants (RAs) will share study information with 5th-7th grade adolescents at a 25-min recruitment assembly at their respective schools. Adolescents interested in participating will receive packets containing consent and assent forms and an eligibility screening tool for both the adolescent and parent. Adolescents will be asked to share information with parents. Adolescents will be told that an adult chosen by the parent will be allowed to serve as the support person if the parent is unable to participate. Adolescents will be informed that if they and their parents are interested in participating, all forms and the screening tool must be completed. If not interested, their parent can check a box on an abbreviated form in the packet to indicate that he/she is not interested in participating or having the adolescent participate; the parent will also be asked to include a signature on the abbreviated form to indicate receipt of the information. Researchers will tell adolescents that if they return completed packets to 1 of 2 RAs present at their school during the next 2 days, they will receive $5 cash as compensation for their effort, regardless of whether they are interested in participating or not.
If >40 interested dyads in a school meet eligibility criteria, the PM will randomly rank the dyads, and our statistician will randomly select the 1st 40 to participate. If the number of eligible adolescents in any school does not reach the anticipated 20 boys and 20 girls, we will continue to recruit.
After an adequate sample size is reached, RAs will contact all parents to let them know if they and their adolescent are included in the study or not, based on the eligibility criteria and number of participants needed. Parents included in the study will be given 2 dates and times to select from to complete baseline data collection at the schools and will be informed that data collection will occur for their adolescents during the school day, except for 3 24-hour dietary recalls (2 weekdays; 1 weekend day) conducted with only the adolescents by phone at 2 time points (baseline and post-intervention).
Parents and adolescents will complete questionnaires via a web-based program delivered by computer. Ht, wt, % body fat, and accelerometer-measured moderate-to-vigorous physical activity (MVPA) will be obtained from all parents and adolescents. Adolescents will complete cardiovascular fitness testing at school and 3 24-hour dietary recalls by phone.
After baseline data are collected, parents will be contacted by a RA to inform them about whether their school will have the GOAL program or not. Parents and adolescents in the control school will be told that they will be contacted again in a little over 4 months for data collection, during which they will complete questionnaires; wear accelerometers; and complete height, weight, and % body fat measures; and adolescents will complete 24-hr dietary recalls and fitness testing. During the next school yr or 13 months post-baseline (9-month F/U), adolescents will be contacted again to complete ht, wt, % body fat, and quality of life measures, and parents will be contacted to complete ht, wt, and % body fat measures at the adolescents' school. Both groups will receive compensation for participation in data collection. Parents and adolescents in the intervention schools will be asked to select 1 of 2 dates and times to attend Dyad Meeting 1 at their adolescents' school to receive information about and begin the intervention.
In November of Yr 2, the 16-wk intervention will begin in 3 schools. During Wk 1 of the intervention, Dyad Meeting 1 will be conducted (120-min event). To accommodate family schedules, the same meeting will occur at 2 time points. During Dyad Meeting 1, a study overview will be presented, and information and behavioral strategies to assist parents in helping their adolescent increase healthy eating and PA will be discussed. The PI, who completed training in motivational interviewing, will discuss use of this communication style with parents alone to help them support their adolescents' PA and healthy eating. Co-Is will meet with adolescents to create a mutually agreed upon GOAL Club behavioral code of conduct. Each parent will receive a GOAL Parent Manual. Parents will be assisted with accessing and using the GOAL social networking website. The chef will conduct a healthy eating and cooking lesson. After Dyad Meeting 1, each dyad will take food home to prepare the demonstrated meal.
The after-school GOAL Club will begin 2 days/wk (26 120 minute events for 13 wks; not conducted during 3 wks of school holiday/winter/spring breaks). We will employ 5 club instructors (2 for PA session [1 male; 1 female]; 2 MSUE educators [1 male; 1 female]) and 1 manager [e.g., racially diverse men and women who have education and experience conducting PA and nutrition programs for adolescents]). We plan to hire instructors from the community where each school is located. We will seek MSU Extension (MSUE) educators from the county where the school is located who have experience delivering nutrition programs for adolescents. At least 1 instructor present at each club session will be certified in first aid and cardiopulmonary resuscitation. Each adolescent will be expected to attend the club 2 days every wk (total 26 events).
The 1st hr of the 120-min club will include: 5 min for organizational tasks and healthy snack. To increase the comfort level of each group during PA, boys and girls will be separated into 2 groups so 1 group can attend the PA session, while the other attends healthy eating and cooking skill-building.
The 50-min "hands on" healthy eating and cooking skill-building session will be conducted by 2 MSUE educators. The session will begin with a discussion of the healthy eating and cooking weekly theme, as well as information and behavioral strategies, that parents are receiving via the GOAL social networking website. MSUE educators will share a motivational message with adolescents. Each wk during the 1st club day, adolescents will be asked to share healthy foods eaten or cooked during the past wk when not at the club; on the 2nd day, adolescents will be asked to share what they plan to do to eat healthy over the next several days until returning to the club. Adolescents will be involved in a healthy eating and cooking skill-building session (45 min). MSUE's mobile kitchens and our GOAL Club Healthy Eating & Cooking Skill-Building Curriculum will be used. Adolescents will be able to sample their prepared healthy beverage, snack, or meal.
The 50-min PA session will include: 5 min for PA weekly theme discussion, including information and behavioral strategies that parents are receiving via the GOAL social networking website. A motivational message will follow. Each wk during the 1st club day, adolescents will be asked to share PAs engaged in during the past wk when not at the club. On the 2nd day, adolescents will be asked to share what they plan to do to attain PA over the next several days until returning to the club. After the discussion, they will engage in 5 min of warm-up/stretching; 20 min of sport skill-building; 15 min of fun games or game to apply learned sports skills; and 5 min of cool-down/stretching.
For the 2nd hr, the group in the 1st hr PA session will switch to the healthy eating and cooking skill-building session. Those in the 1st hr healthy eating and cooking skill-building session will shift to the PA session. Each adolescent will complete 2 multiple-choice items (1 to evaluate attention to information provided; 1 to determine knowledge of skills engaged in) at the end of the PA session and also the end of the healthy eating and cooking session (4 items total/club day). After the club, adolescents will be transported home by school bus.
After Dyad Meeting 1, the GOAL social networking website intervention for parents to complete weekly habit-forming tasks regarding how they helped their adolescents with PA and healthy eating and cooking will begin and include the 3 wks during school holiday/winter/spring breaks. We will include parents having an adolescent in the same school in their own private group in the website. To assist parents in increasing their adolescents' PA and healthy eating, we will post an attractive flyer in the website that is focused on a different theme for parents each wk. Each theme will include: 1) information about PA and healthy eating; 2) 2-3 behavioral strategies related to the information received; and 3) a motivational message. Each weekly healthy habit-forming task will have 4 parts: 1) Parents will be asked to post at least one photo or comment about what has been done to help their adolescents with healthy eating or cooking during the wk . Parents will be asked what they did to help their adolescent attain PA during the wk. Parents will be told that 1 posting on healthy eating and 1 on PA is required, but they can choose to post more often during a wk if they wish. 3) They will be asked to respond to 2 multiple choice questions (one on PA; other on healthy eating) based on the wk's flyer information. 4) They will be asked to respond to at least 1 other parent posting on either PA or healthy eating or cooking with a positive comment.
On Wednesday mornings, parents will receive information on the upcoming wk's healthy habit-forming tasks. Those who do not complete the wk's healthy habit-forming task will receive a text message reminder (other communication system if requested) on the following Saturday morning and phone call on Monday to complete challenges by midnight Tuesday. Trained RAs (1/school) will monitor site activities, usage, and respond to each posting with a brief motivational message. The weekly theme that parents are focusing on will be discussed with adolescents at the beginning of the respective healthy eating and cooking and PA sessions offered in the GOAL Club every wk. Each wk via the website, we will post GOAL Club recipes of the wk, information about PA and healthy eating and cooking skills offered in the club, and pictures for parents to see adolescents engaging in club activities. After the 16th wk, the website will close. The CHCR will manage data from the website.
In Wk 9 of the intervention at Dyad Meeting 2, MSUE educators will lead a discussion on reading nutrition labels and encourage parents to continue to assist adolescents in maintaining PA and healthy eating. A Michigan Walking Clinic instructor will model "good form" walking and involve parents and adolescents in walking demonstrations. MSUE educators will share healthy cooking tips and conduct another hands-on healthy eating and cooking lesson. After Meeting 2, the dyad will take food home to cook the demonstrated meal.
In Wk 16 at Dyad Meeting 3, the PI, PM, and Intervention Coordinator will review information and behavioral strategies for helping parents continue to assist adolescents in maintaining PA and healthy eating, and dyads will receive information about local community resources for both behaviors. MSUE educators will conduct a hands-on healthy eating and cooking lesson. After Meeting 3, each dyad will take food home to prepare the demonstrated meal.
The intervention will end in the 3 schools in early spring of Yr 2. Post-intervention data collection for parents and adolescents in the 6 schools will immediately follow. In Yr 3, parents and adolescents in the 6 schools will complete 9-month post-intervention F/U data collection (13 months post-baseline).
Eight new schools will begin the study in fall of Yr 3, and 8 new schools will start in fall of Yr 4. Procedures will be similar to those used for the 6 schools beginning the study in Yr 2.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Single (Outcomes Assessor)
The 16-wk intervention has 3 components.
In late spring of the prior academic yr, to assist principals with future planning, PI will tell each principal the randomization status of his/her school and need to keep it confidential until pre-intervention/baseline (Wk 0) data collection is complete in early fall. After baseline data collection, adolescents and parents at each school will be told whether they will receive GOAL 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, measurement coordinator, and data manager will not be aware of school randomization status. Data collectors and interventionists are in separate teams and have separate training and meetings.Primary Purpose: Prevention
|Condition ICMJE||Obesity, Adolescent|
|Intervention ICMJE||Behavioral: Guys/Girls Opt for Activities for Life (GOAL)
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 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 (group meetings at each school): 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 during a prior wk.
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Suspended|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||August 31, 2024|
|Estimated Primary Completion Date||February 28, 2024 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Adolescent inclusion criteria are:
Adolescent exclusion criteria are:
Parent/guardian inclusion criteria are:
Parent/guardian exclusion criteria are:
|Ages ICMJE||10 Years to 13 Years (Child)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT04213014|
|Other Study ID Numbers ICMJE||STUDY00002538
R61HL144896 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Responsible Party||Lorraine Robbins, Michigan State University|
|Study Sponsor ICMJE||Michigan State University|
|Investigators ICMJE||Not Provided|
|PRS Account||Michigan State University|
|Verification Date||May 2020|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP