Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04213014 |
| Other study ID # |
STUDY00002538 |
| Secondary ID |
R61HL144896R33HL |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2020 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
June 2024 |
| 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 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 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 882 dyads total (882 adolescents and one
parent per adolescent).
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. 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 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 restricted access. 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. In September 2023 (Yr 4): we enrolled 341
adolescents and 1 parent per adolescent who was willing to be a support person from 5
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 and both to the 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 and adolescents about the study and
invite them 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 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.
In November-December 2022 (Yr 3) and again in 2023(Yr 4), the 16-wk intervention began in 4
schools and then 5 schools, respectively. Parents and adolescents in the intervention group
are asked to select 1 of 2 dates and times to attend Dyad Meeting 1 (occurs in Week 1 of
intervention; 90-min event) at their adolescents' school (or via Zoom if necessary for those
who cannot attend in-person) to receive information about and to begin the intervention. To
accommodate family schedules, the same meeting will occur at 2 time points. During Dyad
Meeting 1, a study overview is presented; and information and behavioral strategies to assist
parents in helping their adolescent increase healthy eating and PA are discussed. The PI, who
completed training in motivational interviewing, will discuss use of this communication style
to help parents 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; 3 for the club) showing the chef conducting a healthy eating and
cooking lesson. After Dyad Meeting 1, each parent will receive a Amazon gift card for
attending the 1st parent-adolescent meeting.
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 adolescents 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 how they
helped or planned 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 the completion of 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 (26 120-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. Our PA Curriculum
will be followed.
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 6 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 also be shown.
In Week 11 (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 that
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 the two types of
PA, and how often adolescents and parents should engage in them per week. Suggestions on how
to optimize PA both indoors and outdoors, 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 reach the Co-Is (if questions arise) who presented the Parent Meeting
2 and 3.
The intervention ended in 4 schools in early spring 2023 (Yr 3) and in 5 schools in early
spring 2024 (Yr 4) . Post-intervention data collection for parents and adolescents in the
schools immediately followed the intervention. In Yr 4, parents and adolescents in the 4
schools completed 9-month post-intervention F/U data collection (13 months post-baseline).
Five new schools will begin the study in fall of Yr 5 (2024). Procedures will be similar to
those used for the schools beginning the study in Yrs 3 and 4.
