Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04213014 |
| Other study ID # |
STUDY00002538 |
| Secondary ID |
R61HL144896R33HL |
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2020 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
April 2023 |
| Source |
Michigan State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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/community center (henceforth referred to as 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 wks due to
no club during 3 school break wks) for boys and girls to engage in physical activity (PA) and
healthy eating/cooking activities; (2) Three parent-adolescent meetings (1st meeting at each
school; 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 will be
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
physical activity, network with other parents, and share with each other about how they
helped their adolescent(s) increase PA and diet quality during a prior 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 underserved 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 880 dyads total (880 adolescents with
one of their parents).
Description:
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/community centers (for brevity sake,
referred to as schools in the remaining document) will be randomly assigned by our senior
biostatistician to either the 16-wk GOAL intervention or a routine school offerings control
condition. One parent/guardian (henceforth 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 PI and
PM will conduct a 4-hour training session on protocols for the research team. All recruiters,
data collectors, and interventionists will be trained.
R33 Phase (Yrs 3-6): R33 was received in 2021; however, study had to be stopped in fall 2021
due to COVID-19 variant and the increased number of positive cases in Michigan that resulted
in school closures and restrictions. Individuals external to the schools were not able to
enter some schools, and access to students in the schools was limited.
In September 2022 (Yr 3): we enrolled 218 adolescents and 1 parent per adolescent who was
willing to be a support person from 4 schools. Our biostatistician randomly assigned the
adolescents in each school to the intervention or control (usual school activities)
condition.
At the beginning of each academic school year, the PI, PM, Measurement Coordinator and/or
Intervention Coordinator, and 2 research assistants (RAs) will share study information with
5th-8th grade adolescents at a 25-min recruitment assembly at their respective schools. The
team will also attend school Open Houses before the start of school to inform
parents/guardians and adolescents when the assembly will occur in the fall and to distribute
a flyer to parents/guardians and adolescents about the study. The assembly will be
specifically called in the school for this particular study to invite adolescents to
participate. During the assembly, adolescents will receive a flyer with a QR code to link
adolescents to the assent form and parents to the consent form, eligibility screening tool,
and baseline survey. Adolescents will be asked to share information with parents. Parents
will also receive an email from each school's administration to share information about the
study and invite them to participate with their adolescent. The email will include the flyer
and QR code so that they can link directly to the assent form, consent form, eligibility
screening tool, and baseline survey. Adolescents will be told that an adult chosen by the
parent will be allowed to serve as the support person if their parent is unable to
participate. Parents and adolescents will be asked to complete the forms online within the
next 48 hours if interested in participating. Parents will also be invited to participate
with their adolescents by researchers who will be present at various school events, such as
sporting, registration, and conferences.
If acceptable to school administrators, the school's social media site (e.g., Facebook page),
email, or text messages will be used to inform parents/guardians and adolescents about the
study and invite them and their adolescents to participate. A link will be provided for
parents and adolescents to complete forms online. Recruitment will also occur at lunch,
during study or library periods, and in classrooms or other venues (will depend on permission
granted by the school administrators). A 90-second video has been made and will be shown at
the school. Flyers about the study with a QR code will be available in classrooms or other
areas in the school for adolescents to take home. The QR code can be used by those interested
in participating to easily access study information and complete forms (as noted above).
Strategies used may vary in each school depending upon the permission and recommendations
received from school administrators.
Response rates will be recorded. Although not expected, if an acceptable number of
adolescents in a school does not meet eligibility criteria (after several recruitment
attempts) or an acceptable number is not reached, the research team will recruit higher
numbers of participants in subsequent schools. If far more than enough dyads meet eligibility
criteria, the PM will rank and number the participants; and our biostatistician will use a
computer algorithm to randomly select (from ranked numbers) the appropriate number to
participate. If any drop out before baseline data collection, they will be replaced by
reserves when possible. No replacements will occur after baseline data collection.
After an adequate sample size is reached, research assistants (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 will be informed that data
collection will occur for their adolescents during the school day at baseline,
post-intervention, and 13 months post-baseline (9-month F/U). Adolescents will complete
questionnaires online to assess their perceptions related to PA and healthy eating at
baseline and post-intervention. At all 3 time points, quality of life will be assessed; and
height, weight, % body fat will be obtained. At baseline and post-intervention, adolescents'
moderate-to-vigorous physical activity (MVPA) via accelerometer will be measured, and they
will complete cardiovascular fitness testing at school. Two 24-hour dietary recalls (1
weekday; 1 weekend day) will be conducted with only the adolescents by phone at 2 time points
(baseline and post-intervention). To reduce parent burden, stress, and strain (noted by
principals due to both the pandemic and inflation), only subjective (self-reported) online
survey data will be collected from parents. Parents will complete an online survey at
baseline and post-intervention; and also report their height and weight at baseline,
post-intervention, and 9-mon. F/U. Therefore, we will not be able to measure percent body fat
on the parents.
After baseline data are collected, parents will be contacted by a RA to inform them about
whether they will receive the GOAL intervention program or not. Parents and adolescents in
the control condition will be told that in a little over 4 months they will be contacted for
data collection and again in the next school year for 9-month F/U. Both groups will receive
compensation for participation in data collection.
Parents and adolescents in the intervention group will be asked to select 1 of 2 dates and
times to attend Dyad Meeting 1 at their adolescents' school (or via Zoom if necessary) to
receive information about and begin the intervention. In November-December 2022 (Yr 3), the
16-wk intervention began in 4 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 and will be
offered via ZOOM for those who cannot attend in-person. 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. A GOAL Club
behavioral code of conduct will be discussed. Each parent will receive a GOAL Parent Manual
and cookbook. Parents will be assisted with accessing and using the GOAL social networking
website. A video of the chef (prepared in R61 Phase) will be shown. This video is one of six
total (3 for parent-adolescent meetings and 3 for the club) showing the chef conducting a
healthy eating and cooking lesson. After Dyad Meeting 1, each parent will receive a $20.00
Amazon gift card for attending the 1st parent-adolescent meeting in-person. A $15.00 Amazon
gift card will be given for attending the 1st parent-adolescent meeting via Zoom.
After Dyad Meeting 1, the GOAL social networking website intervention for parents will begin.
It will include the 3 weeks during school holiday/winter/spring breaks (every week for 16
weeks). We will only include parents with adolescents at the same school in their own private
group on the website. To assist parents in increasing their adolescents' PA and healthy
eating, we will post an attractive flyer on the website that is focused on a different theme
for parents each week, which will also align with the themes the students learn in the
after-school club. 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.
Parents will be asked to complete weekly habit-forming tasks regarding how they helped their
adolescents with PA and healthy eating/cooking. Each weekly healthy habit-forming task will
have 3 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/cooking or PA during the week. 2)
They will be asked to respond to 2 multiple choice questions (one on PA; other on healthy
eating) based on the week's flyer information. 3) They will be encouraged 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 week's healthy
habit-forming tasks. Those who do not complete the week's healthy habit-forming task will
receive a text message reminder every day until the task is completed. Once completed, text
reminders cease. If a parent does not complete the weekly tasks consistently, a RA will
contact the parent by phone to discuss any barriers preventing them from completing the
tasks. Trained RAs will monitor site activities, usage, and all postings. RAs will respond
with a positive comment to all parents who posted about PA and healthy eating. The weekly
theme that parents are focusing on will be discussed with adolescents at the beginning of the
respective healthy eating/cooking and PA sessions offered in the GOAL Club every week. Each
week via the website, we will post GOAL Club recipes of the week, information about PA and
healthy eating/cooking skills offered in the club, and pictures for parents to see
adolescents engaging in club activities if available. The CHCR will manage data from the
website.
The after-school GOAL Club will occur 2 days/week for 13 weeks (26 x 120 minute events over
the course of 13 weeks; not conducted during school holiday/winter/spring breaks). We will
employ 5 club instructors/coaches (2 for PA session [1 male; 1 female]; 2 nutrition 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 to serve as coaches for the PA and nutrition program from the university and
local communities where a school is located. 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 week (total 26 events).
The first 5 min of the 120-min club will include: organizational tasks, healthy snack, and
receipt of a motivational message to encourage PA and healthy eating and promote positive
perceptions. 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. Gender non-conforming adolescents will be able to choose
which group to participate with. Either group will begin with PA, then switch to healthy
eating/cooking skill-building session and vice versa.
The 50-min "hands on" healthy eating/cooking skill-building session will be conducted by 2
nutrition coaches. The session will begin with a discussion of the healthy eating/cooking
weekly theme, as well as information and behavioral strategies that parents are receiving via
the GOAL social networking website. Each week during the 1st club day, adolescents will be
asked to share healthy foods eaten or cooked during the past week 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/cooking skill-building session (45-50 min). 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. Each week during the 1st club day, adolescents will be asked to share PAs
engaged in during the past week 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 10 min of dynamic warm-ups and fun
physically active games; 20 min of sport skill-building; 10 min of fun physically active
game(s) to apply learned sports skills; and 5 min of static stretching.
In the final 5 minutes of the club, each adolescent will be provided with a snack that they
can enjoy while completing 4 multiple-choice questions (to evaluate information provided).
After the club, adolescents will be (1) released to walk home if approved by parents, (2)
picked up by parents, or (3) transported home by school bus.
In Week 9 of the intervention (Meeting 2: recorded asynchronous video session), a Co-I will
review nutrition labels, why they are required and what information they contain. Nutrition
facts on fats, cholesterol, sodium, sugar and proteins are shared to encourage parents to
review the labels when purchasing groceries. Healthy cooking tips, suggestions to select
healthy foods at restaurants and techniques to encourage adolescents to maintain healthy
eating will also be presented. The chef's video on healthy eating/cooking and preparing a
healthy meal will be shown.
In Week 15 (Meeting 3: recorded asynchronous video session), a Co-I will review information
and behavioral strategies for helping parents continue to assist adolescents in maintaining
PA. The session will begin by discussing how to start the physical activity journey slowly.
SMART goals, good form walking, warming up and stretching will be introduced. A video will
demonstrate "good form" walking will be shown as well. The Co-I will present information on
moderate and vigorous physical activity, what the differences are between them and how often
adolescents and parents should engage in them per week. Suggestions on how to optimize
physical activity both indoor and outdoor, how to improve sleep and become more physically
active overall will be provided.
In a follow up email to the last Parent Meeting, the dyads will receive information about
local community resources, the 3rd video with the chef preparing a healthy meal, as well as
contact information to the Co-Is presenting the Parent Meeting 2 and 3 will provided.
The intervention ended in the 4 schools in early spring 2023 (Yr 3). Post-intervention data
collection for parents and adolescents in the 4 schools immediately followed. In Yr 4,
parents and adolescents in the 4 schools will complete 9-month post-intervention F/U data
collection (13 months post-baseline).
Five new schools will begin the study in fall of Yr 4 (2023); and 5 new schools will start in
fall of Yr 5 (2024). Procedures will be similar to those used for the 4 schools beginning the
study in Yr 3.
