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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
Sponsor:
Collaborators:
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Lorraine Robbins, Michigan State University

Tracking Information
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
 (submitted: December 24, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Change from Baseline Body Mass Index (BMI) and Change from Baseline Overweight/Obesity Percentage (adolescents; wt and ht will be combined to estimate) to 4 months (immediate post-intervention) and to 13 months post-baseline (9-month follow up) [ Time Frame: baseline (0 months), immediately post-intervention (after 4 months), and 9-month follow up (13 months post-baseline) ]
    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.
  • Change from Baseline Cardiovascular (CV) Fitness (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    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).
  • Change from Baseline Minutes of Moderate-to-Vigorous Physical Activity (MVPA; adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    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 phone call (text message if prefer) 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.
  • Change from Baseline Quality of Life (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) ]
    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.
  • Change from Baseline Diet Quality (e.g., healthy eating index, servings of fruit and vegetables, sweetened beverage consumption; adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    Adolescents will complete 3 non-consecutive 24-hr dietary recalls (1 weekend day; 2 weekdays; randomly selected) over 2-3 wks at baseline and post-intervention. The Minnesota Nutrition Data System for Research will be used to assess diet quality and obtain a healthy eating index score. The Project Manager and Measurement Coordinator will be trained at the University of Minnesota Nutrition Coordinating Center (2 days) and certified. They will train RAs to collect data from each adolescent via telephone. Adolescents unable to be reached by phone will be contacted at school to complete recalls during the school day. 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 Nutrition Data System for Research (NDSR) software will be used to conduct full dietary analysis. Data will be analyzed by the Coordinating Center.
  • Change from Baseline Physical Activity Self-Efficacy (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    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.
  • Change from Baseline Social Support for Physical Activity (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    A 5-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) everyday. A higher score means a better outcome.
  • Change from Motivation for Physical Activity (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    A 19-item 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 (0) to (4) very true for me. A higher score means a better outcome.
  • Change from Baseline Self-Efficacy for Healthy Eating (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    A 9-item Child Dietary Self-Efficacy Scale will be used to determine adolescents' confidence in healthy eating. Response choices are: (0) not sure, (1) a little sure, and (2) very sure. A higher score means a better outcome.
  • Change from Baseline Social Support for Healthy Eating (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    A 14-item Family and Friend 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.
  • Change from Baseline Motivation for Healthy Eating (adolescents) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    Motivation for healthy eating will be assessed with 2 different scales. A 24-item Regulation of Eating Behaviors Scale will be used to assess adolescents' motivation for healthy eating. Response choices range from not true for me (0) to very true for me (4). A 24-item Tempest Self-regulation Questionnaire for Healthy Eating (TESQ-E) will be used to assess adolescents' motivation for healthy eating based on strategies used for healthy eating. Responses choices are: (0) never, (1) rarely, (2) sometimes, and (3) often. A higher score on each scale means a better outcome.
  • Change from Baseline Family Nutrition and Physical Activity (exploratory aim; parents/guardians) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    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.
  • Change from Baseline Minutes of Moderate-to-Vigorous Physical Activity (MVPA; exploratory aim; parents/guardians) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    The ActiGraph triaxial accelerometer (GT3X-plus) will record acceleration counts from which min. of MVPA will be estimated (analysis software available). Parents/guardians will receive accelerometers and instructions regarding wear during data collection times scheduled at their adolescents' school. Data collection procedures for parents/guardians will be similar to those employed for adolescents. However, different accelerometer cut-points will be used for parents: sedentary (≤99 counts/60 sec), light (100-1951 counts/60 sec), moderate (1952-5724 counts/60 sec), and vigorous (≥5725 counts/60 sec).
  • Change from Baseline Diet Quality (exploratory aim; parents/guardians) to 4 months (immediate post-intervention) [ Time Frame: baseline (0 months) and immediately post-intervention (after 4 months) ]
    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.
  • Change from Baseline Percent (%) Body Fat (exploratory aim; parents/guardians) 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) ]
    For % body fat, parents will be asked to avoid exercise on testing day and void before testing. Because we are mainly concerned about improving adolescent body composition and parent testing may occur in late morning or early evening, food and water will not be restricted. Other procedures for parents/guardians will be similar to those employed for adolescents.
  • Change from Baseline Body Mass Index (BMI; exploratory aim; parents/guardians) 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) ]
    BMI will be calculated based on weight (kilograms)/height (meters squared). Procedures for measuring parents'/guardians' height and weight will be similar to those employed for adolescents.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Brief 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 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).

Detailed Description

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:

The 16-wk intervention has 3 components.

  1. After-School GOAL Club for moderate-to-vigorous physical activity (MVPA) and healthy eating and cooking skill-building (13 wks; 120 min/event [N=26]; 2 d/wk; not offered for 3 wks of holiday, winter, spring school breaks).
  2. Three Parent-Adolescent Meetings to empower participants regarding physical activity (PA) and healthy eating and cooking (120 min/meeting [N=3]; Wks 1, 9, & 16).
  3. GOAL Social Networking Website for Parents to help their adolescents with MVPA and healthy eating and cooking (parents will complete weekly healthy habit-forming tasks; Wks 1-16). The website will offer information, encouragement, and behavioral strategies to help parents increase their adolescents' PA and healthy eating.
Masking: Single (Outcomes Assessor)
Masking Description:
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
  • 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;5 (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.
    Intervention: Behavioral: Guys/Girls Opt for Activities for Life (GOAL)
  • No Intervention: Control
    Received usual school activities.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 24, 2019)
1760
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

Inclusion Criteria:

Adolescent inclusion criteria are:

  1. 5th-7th grade boys and girls (ages 10-13)
  2. available and willing to participate in GOAL, including the after-school club 2 days/week for 13 weeks (not during 3 weeks of holiday/winter/spring school breaks)
  3. available for follow up (9 months after intervention ends)
  4. agree to random assignment
  5. able to read, understand, and speak English
  6. able to identify one parent/guardian who is willing and able to serve as a support person and complete study activities
  7. plan to remain in same school over next 2 years
  8. BMI z-score >0 (when completed recruitment packets are returned to each school, all adolescents who assent and have parental consent will have ht. and wt. measured by trained and blinded RAs at each school).

Adolescent exclusion criteria are:

  1. involvement in school or community sports or other organized physical activities (PAs), such as dance lessons, that involve MVPA and require participation after school 4 or more days/wk during every season of the school year
  2. mental or physical health condition precluding safe MVPA
  3. taking medications that alter appetite, weight, or growth.

Parent/guardian inclusion criteria are:

  1. have male or female student in 5th-7th grade
  2. ≥18 yrs. of age
  3. available and willing to participate in GOAL
  4. able to read, understand, and speak English
  5. have Internet access and device for accessing website (e.g., mobile phone ["smart" phone], tablet, computer)
  6. willing and 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: In each school, an equal number of boys (n=20) and girls (n=20) and one parent/guardian per adolescent (male or female who is willing to serve as a support person) will be included.
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  
 
Administrative Information
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
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.
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.
Responsible Party Lorraine Robbins, Michigan State University
Study Sponsor  ICMJE Michigan State University
Collaborators  ICMJE
  • University of Michigan
  • National Heart, Lung, and Blood Institute (NHLBI)
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