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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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).


Condition or disease Intervention/treatment Phase
Obesity, Adolescent Behavioral: Guys/Girls Opt for Activities for Life (GOAL) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1760 participants
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
Official Title: Guys/Girls Opt for Activities for Life Trial
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

No Intervention: Control
Received usual school activities.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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).

  14. 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.

  15. 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.

  16. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 13 Years   (Child)
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.
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213014


Locations
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United States, Michigan
Michigan State University
East Lansing, Michigan, United States, 48824
Sponsors and Collaborators
Michigan State University
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
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Responsible Party: Lorraine Robbins, Associate Professor, Michigan State University
ClinicalTrials.gov Identifier: NCT04213014    
Other Study ID Numbers: STUDY00002538
R61HL144896 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lorraine Robbins, Michigan State University:
exercise
nutrition
parent
adolescent
overweight
percent body fat
cardiorespiratory fitness
body mass index
obesity
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms