Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase Young Adolescents' Physical Activity and Healthy Eating (GOAL)

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/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).

Study Overview

• Status: Recruiting
• Conditions: Obesity, Adolescent
• Intervention / Treatment: Behavioral: Guys/Girls Opt for Activities for Life (GOAL)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1764
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Niko Kaciroti, PhD; Phone Number: 734-763-9714; Email: nicola@umich.edu
      • Contact: Kenneth Resnicow, PhD; Phone Number: 7349043888; Email: kresnic@umich.edu
      • Principal Investigator: Niko Kaciroti, PhD
      • Sub-Investigator: Kenneth Resnicow, PhD
    • East Lansing, Michigan, United States, 48824
      • Recruiting
      • Michigan State University
      • Sub-Investigator: Karin A Pfeiffer, PhD
      • Contact: Jiying Ling, PhD; Phone Number: 517-353-8591; Email: lingjiyi@msu.edu
      • Contact: Lorraine B Robbins, PhD; Phone Number: 517-353-3011; Email: robbin76@msu.edu
      • Principal Investigator: Lorraine B Robbins, PhD
      • Sub-Investigator: Jiying Ling, PhD
      • Sub-Investigator: Jean Kerver, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Adolescent inclusion criteria are:

1. 5th-8th grade boys and girls (ages 10-14)
2. available and willing to participate in GOAL, including the school/community center club conducted after school 2 days/week for 13 weeks (not during 3 weeks of school/community center breaks)
3. available for follow up (9 months after intervention ends)
4. agree to random assignment
5. able to read, understand, and speak English or have an interpreter
6. able to identify one parent/guardian who is willing and able to serve as a support person and complete study activities

Adolescent exclusion criteria are:

1. mental or physical health condition precluding safe MVPA
2. taking medications that alter appetite, weight, or growth.

Parent/guardian inclusion criteria are:

1. have male or female student in 5th-8th grade
2. ≥18 yrs. of age
3. available and willing to participate in GOAL
4. able to read, understand, and speak English or have an interpreter
5. have Internet access and device for accessing website (e.g., mobile phone ["smart" phone], tablet, computer) and a cellphone which can receive text messages.
6. mentally and physically able to serve as a support person.

Parent/guardian exclusion criteria are:

1. mental or physical health condition precluding engagement in safe MVPA and healthy meal preparation with adolescent
2. not interested in using a private social networking website, similar in design to Facebook, to respond to challenges
3. not interested in learning to post.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Received usual school activities.
Experimental: 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 during a prior wk.	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 days/week; 120 min/event/day; 13 weeks due to no club during 3 school break weeks) 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 for 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 during a prior week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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])	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.	baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]).	Two data collectors will measure each adolescent behind privacy screen. Ht without shoes will be measured to nearest 0.10 cm with a stadiometer. Data collectors will position adolescent next to the stadiometer board with head in the Frankfurt horizontal plane. Wt in kg to nearest 0.10 kg will be measured using a foot-to-foot bioelectric impedance scale. Two measurements will be taken for ht and wt. If the 2 differ by <0.5 cm and <0.5 kg, they will be averaged to determine final ht and wt, respectively. If the 2 ht measurements differ by ≥0.5 cm and wt measurements differ by ≥0.5 kg, a 3rd one will be taken. If the 3rd measurement is ≥0.5 cm or ≥0.5 kg. different from the other 2, process will be repeated and another RA will measure. Wt and ht will be combined to estimate BMI for age and sex and overweight/obesity percentage by using the Statistical Analysis System/Software program for Centers for Disease Control and Prevention (CDC) Growth Charts.	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)	The Progressive Aerobic Cardiovascular Endurance Run (PACER), a 20-meter shuttle run, will be used to estimate aerobic capacity and CV endurance. Guided by a PACER Compact Disc (CD), adolescents will run as long as possible back and forth across a 20-meter or 15-meter (if 20-meters not available) flat surface at a pace that gets faster each min. A lap is one 20-meter or 15-meter distance (from one end to the other). Two RAs will mark the testing area with floor tape. RAs will ask no more than 6 adolescents at a time to run from one line to another until they cannot keep up the pace. One RA will be responsible for no more than 3 boys or girls. The scorer will record the total number of laps completed by each adolescent. Scores will be transferred to a laptop computer. A mile equivalency value will be determined and entered into an equation, according to recommendations. CV fitness is assessed via estimation of maximal oxygen consumption (VO2max).	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)	The ActiGraph triaxial (GT3X-plus) accelerometer will record acceleration counts from which min of MVPA will be estimated (analysis software available). Instructions will be provided: right hip (attached to belt) from time getting out of bed in morning to time returning to bed at night for 7 consecutive days. To remind each adolescent to wear it, each will receive a text message (phone call if preferred) at home every morning. Monitors will be initialized and set to begin data collection at 5 o'clock in the morning on the day after they are distributed to adolescents at school. Adolescents will return monitors at school after the 7th day. Data will be downloaded to the same computer used to initialize monitors. Initial analysis will use 15-sec epochs and count thresholds for activity intensities: moderate (574-1002 counts/15 sec) and vigorous PA (≥1003 counts/15 sec). Fifteen-sec increments with counts ≥574 will be summed to determine min/hr of MVPA.	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]).	The 23-item Pediatric Quality of Life Inventory (Peds QL), which will be used to measure adolescents' health-related quality of life, consists of 4 domains: physical (8 items), emotional (5 items), social (5 items), and school (5 items). Adolescents will respond to a 5-point Likert scale (0 = never; 1 = almost never; 2 = sometimes; 3 = often; 4 = almost always) to indicate how much of a problem each item has been for them during the past month. Items are reverse-scored and transformed to a 0 - 100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) so that the higher the score, the better the quality of life.	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)	Adolescents will complete 2 non-consecutive 24-hr dietary recalls (1 weekend day; 1 weekday; randomly selected) over 2-3 weeks at baseline and post-intervention. The Minnesota Nutrition Data System for Research (NDSR) will assess diet quality and obtain a healthy eating index score. Trained staff will collect data from each adolescent via telephone. Adolescents unable to be reached by phone will be contacted at school to complete recalls. To aid in assessing portion sizes, 2-dimensional food models and measuring guides will be given to adolescents at school. The 24-hr recall method, including phone interviews, has been validated in children. The NDSR software will be used to conduct full dietary analysis. Data will be analyzed by the Coordinating Center.	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)	A 6-item Perceived Physical Activity Self-Efficacy Scale will be used to assess adolescents' confidence in overcoming barriers (e.g., I can be active in my free time on most days even when I am busy). Response choices range from: (0) not at all sure to (3) very sure. A higher score means a better outcome.	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)	A 8-item Family and 3-item Friend Support Scale will be used to determine adolescents' perceptions of the total instrumental assistance and emotional encouragement for physical activity received from significant others. Response choices range from: (0) never to (5) very often. A higher score means a better outcome.	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)	Twelve items from the Behavioural Regulation in Exercise Questionnaire (BREQ-3) will be used to assess adolescents' motivation for PA. Response choices range from: (0) not true for me to (4) very true for me. A higher score means a better outcome.	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)	A 9-item Child Dietary Self-Efficacy Scale will be used to determine adolescents' confidence related to healthy eating. Response choices are: (0) not at all sure, (1) not very sure, (2) somewhat sure, and (3) very sure. A higher score means a better outcome.	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)	An 8-item Family (4 items) and Friend (4 items) Support for Healthy Eating Scale will be used to assess adolescents' perceptions of family and friend instrumental assistance and emotional support for healthy eating. Response choices include: (0) never, (1) rarely, (2) sometimes, (3) often, and (4) very often. A higher score means a better outcome.	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)	Motivation for healthy eating will be assessed with 12 items from the Regulation of Eating Behaviors Scale. Response choices range from not true for me (0) to very true for me (4).	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)	Parents/guardians will complete a 20-item Family Nutrition and Physical Activity Screening Tool that will be used to evaluate health behaviors in the home. Response choices range from: (1) never/almost never to (4) very often/always. A higher score means a better outcome.	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)	All parents will complete the International PA Questionnaire. The questionnaire is a 7-day recall of PA behavior. It is used with adults to determine the frequency (days/week) and duration (mins/day) of various activities, such as walking, moderate PA (carrying light loads, bicycling at a regular pace), and vigorous PA (heavy lifting, aerobics, or fast bicycling). Responses will be converted to metabolic equivalent task minutes per week (MET-min/week). Parents will be classified as participating in low, moderate, or high levels of PA based on a scoring protocol.	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)	All parents will complete the 10-item Block Fruit-Vegetable-Fiber Screener. Response range from: (1) Less than 1/WEEK to (5) 2+ a DAY. A higher score means a better outcome.	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])	BMI will be calculated based on weight (kilograms)/height (meters squared). Parents/guardians will self-report height and weight for the analysis of BMI.	baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline)

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2020
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: exercise; body mass index; obesity; overweight; adolescent; nutrition; parent; cardiorespiratory fitness; percent body fat
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: STUDY00002538; R61HL144896 (U.S. NIH Grant/Contract); R33HL144896 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data and study documentation materials will be released to the NHLBI and within the timelines described in the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies. The data sets will be submitted to the study NHLBI Program Official no later than 3 years after the end of the final follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
• IPD Sharing Time Frame: The data sets will be submitted to the study NHLBI Program Official no later than 3 years after the end of the final follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
• IPD Sharing Access Criteria: We plan to adhere to the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies and Guidelines for NHLBI Data Set Preparation. Documentation for data sets will be clear to enable other researchers not familiar with a data set to use it in the future. A summary documentation file will be created to provide a complete overview of the data and description of their use for researchers who are not familiar with the data set. Data will only be made available under terms consistent with the informed consent provided by individual participants, and as approved by the Michigan State University (MSU) Human Research Protection Program/Institutional Review Board (IRB) and any local, state, and federal laws and regulations. In addition, de-identified electronic data will be archived in the MSU College of Nursing (CON) for use by faculty, students, or other researchers in the future. Interested users will be asked to contact the PI and sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No