- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02932813
Translational Health After School Program on Health-Related Knowledge/Behaviors and Exercise Perception (THINK)
The Effects of a Translational Health After School Program on Health-Related Knowledge/Behaviors and Exercise Perception in Minority Children
The aim of this study is to examine the effects of a translational health in nutrition and kinesiology (THINK) after school program on physical variables, nutrition and exercise knowledge base/behaviors, and exercise enjoyment and confidence.
Partnering with the YMCA investigators in the Kinesiology and Sport Sciences department at the University of Miami will set up the after-school THINK program offered three afternoons per week for nine months in two experimental and two control schools. The schools will consist of minority elementary school students (predominantly Hispanic and Black) in the South Florida area. The control schools will receive baseline, mid-year and follow-up testing nine months later, but will not go through the THINK program. They will instead go through their standard YMCA after school Sports, Play, and Active Recreation for Kids (SPARK) program.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two- thirds of American adults are overweight or obese, and that number continues to rise. Thus, it is not surprising that the prevalence of overweight/obesity has more than doubled in school children and tripled in adolescents. Concomitant with the rise in obesity has been a significant decrease in physical fitness levels (1,2). At least one study has shown the youth of today demonstrate lower aerobic fitness levels than their parents (3). Low aerobic fitness levels are most prevalent among Hispanic and Black (non-Hispanic) minority youth. No doubt the increases in TV viewing, computer time and technology have contributed to the increase in sedentary habits and decline in physical activity levels (4).
The THINK program translates fitness and health-related information into knowledge and skills that children can understand and incorporate into their own personal health and lifestyle behaviors. The program is unique in that it combines educational and hands-on clinical experiences with physical activity and exercise. The goal is to promote healthier, more active children of today who demonstrate improved levels of physical fitness, exercise knowledge, and enjoyment of tomorrow.
Each unit in the THINK program has three components: a seminar on the scientific aspects of a health-related theme, clinical experiences related to the theme, and related physical activities performed in the field. The THINK seminars engage students by getting them up and moving, while asking questions that prompt them to think creatively to come up with their own answers. Clinical experiences reinforce the educational themes allowing children to learn more about their bodies, how it functions, and how it adapts through various movement exercises. Finally, games and enjoyable physical activities round out the program contributing to enhanced motor skill development and improved physical fitness levels.
The THINK program will begin with a series of baseline physical assessments comprising both heath and performance-related physical fitness. Participants will also receive a quiz on nutrition and exercise-related information and two surveys regarding nutritional behaviors and physical activity levels. They will be asked to complete one survey on exercise enjoyment and self-confidence. Parents will also be asked to complete a survey each on their child's nutritional habits. This will be done in two experimental and two control YMCA after school programs comprising primarily minority (Hispanic and Black) participants. Testing will again take place midway through the program and at the conclusion of the program nine months later. The control group will not go through the THINK program but will instead go through the traditional SPARK curriculum.
The purpose of the study is to determine whether the THINK program results in improvements in physical fitness, nutrition and exercise knowledge/habits, and exercise enjoyment and self-confidence above that of the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Coral Gables, Florida, United States, 33124
- University of Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children in grades 3-5 (aged 8-12)
- enrolled in a YMCA after-school program
Exclusion Criteria:
- Inability to perform physical activity
- Any cardiovascular, metabolic, or neurological disorders that would affect the child's ability to participate in the program or in testing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
THINK intervention: The program will have activity and fitness sessions lasting two hours, three times a week for a total of nine months. Sessions will include theory, clinical laboratory activities, and physically active games to facilitate a fun environment to enhance physical and health-related fitness, improve nutrition and exercise knowledge and behaviors, and exercise enjoyment and self-confidence. |
Lessons and laboratory sessions will be 60 minutes, followed by physical activity sessions lasting 60 minutes.
Laboratory activities include assessing heart rate, making healthy meals, learning portion sizes, brain challenges, and more.
To improve physical activity participation, a wide selection of developmentally appropriate and multiculturally sensitive activities will be offered, such as sports, games, obstacle courses, and dance.
|
|
No Intervention: Control Group
This group will receive the traditional YMCA SPARK after-school program.
They will undergo the same pre, mid, and post testing protocol as the intervention group, but will not receive the THINK program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Measures
Time Frame: Baseline, at 4 months, and at 9 months
|
Resting heart rate and blood pressure will be assessed using an automatic blood pressure cuff.
|
Baseline, at 4 months, and at 9 months
|
|
Aerobic fitness
Time Frame: Baseline, at 4 months, and at 9 months
|
An NIH 2 minute walk test will be used to assess aerobic fitness.
|
Baseline, at 4 months, and at 9 months
|
|
Agility and speed
Time Frame: Baseline, at 4 months, and at 9 months
|
A shuttle run will be used to assess agility and speed.
|
Baseline, at 4 months, and at 9 months
|
|
Upper-body strength and endurance
Time Frame: Baseline, at 4 months, and at 9 months
|
A hand-grip dynamometer will be used to assess upper body strength and endurance
|
Baseline, at 4 months, and at 9 months
|
|
Abdominal strength and endurance
Time Frame: Baseline, at 4 months, and at 9 months
|
A one minute curl-up (sit up) will be used to assess abdominal strength and endurance.
|
Baseline, at 4 months, and at 9 months
|
|
Lower body power
Time Frame: Baseline, at 4 months, and at 9 months
|
The height of a vertical jump test will be used to assess lower body power.
|
Baseline, at 4 months, and at 9 months
|
|
Flexibility
Time Frame: Baseline, at 4 months, and at 9 months
|
A lower body sit and reach test will be used to assess flexibility.
|
Baseline, at 4 months, and at 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Composition
Time Frame: Baseline, at 4 months, and at 9 months
|
Electrical impedance and 3 site Skinfolds
|
Baseline, at 4 months, and at 9 months
|
|
Body fat distribution
Time Frame: Baseline, at 4 months, and at 9 months
|
Waist and hip circumference will be measured
|
Baseline, at 4 months, and at 9 months
|
|
Exercise Enjoyment and Confidence
Time Frame: Baseline, at 4 months, and at 9 months
|
A modified Exercise Enjoyment Scale and a modified Exercise Self-Confidence Scale will be given
|
Baseline, at 4 months, and at 9 months
|
|
Knowledge/Behaviors/Habits
Time Frame: Baseline, at 4 months, and at 9 months
|
International Physical Activity Questionnaire (IPAQ) and The CATCH Kids Club questionnaire will be given.
|
Baseline, at 4 months, and at 9 months
|
|
Nutritional survey
Time Frame: Baseline, at 4 months, and at 9 months
|
A parental survey of family nutrition behaviors will be given and An Exercise Physiology and Nutrition Knowledge Base Test
|
Baseline, at 4 months, and at 9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20160719
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Changes in Physical Fitness
-
University of Alabama at BirminghamCompletedPhysical Fitness in Older AdultsUnited States
-
The President Stanisław Wojciechowski State University...CompletedPhysical Performance and Fitness in Old AgePoland
-
Eastern Switzerland University of Applied SciencesRecruitingExercise Program | Physical Fitness in Older AdultsSwitzerland
-
Hasan Kalyoncu UniversityCompletedPhysical Fitness and Balance in Older AdultsTurkey (Türkiye)
-
Kastamonu UniversityCompletedAthletic Performance | Muscle Strength | Physical Fitness | Plyometric Exercise Adaptations | Neuromuscular Performance in AthletesTurkey (Türkiye)
-
Riphah International UniversityCompletedPhysical Fitness | Cardiorespiratory FitnessPakistan
-
Shen XinCompletedPhysical Fitness Deficits in Firefighters | Exercise Adherence Challenges | Injury Risk Associated with Firefighting TasksChina
-
University of LjubljanaScience and Research Centre KoperCompletedPhysical Fitness | Physical Examination | Aerobic Capacity | Cardio Respiratory Fitness | Combat PreparednessSlovenia
-
MMSx Authority Institute for Movement Mechanics...BodyGNTX Fitness Institute; GFFI Fitness Academy; Indian Institute of Kinesiology... and other collaboratorsRecruitingPhysical FitnessUnited States, India
-
Universiti Putra MalaysiaRecruiting
Clinical Trials on THINK Program
-
University of PennsylvaniaCompleted
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Queen's University, BelfastWellcome TrustCompletedSubjective Cognitive ImpairmentUnited Kingdom
-
Medical College of WisconsinUniversity of Wisconsin, Milwaukee; Children's Hospital and Health System Foundation... and other collaboratorsCompletedPediatric ALLUnited States
-
University of MiamiUniversity of TennesseeCompletedObesity | Cognitive Function 1, Social | Physical Fitness
-
Harvard UniversityCompletedDepression | Stress | AnxietyUnited States
-
University of PittsburghAmerican Heart AssociationRecruitingCardiovascular Disease | Chronic Kidney DiseaseUnited States
-
Leeds Beckett UniversitySköshify™ Corporate HQ, 7045 Quiet Retreat Court, Niwot, CO 80503-7174RecruitingDepression | Stress | Mental Fatigue | Anxiety | Blood Pressure | Sleep Quality | Working Memory | Heart Rate | Cortisol | Cognitive Assessment | Cognitive Flexibility | Physical Fatigue | Executive Function (Cognition) | Inhibitory Control | Productivity | Sustained Attention | EffortUnited Kingdom
-
Laureate Institute for Brain Research, Inc.National Institutes of Health (NIH); National Institute of General Medical...RecruitingBipolar Disorder I or II | Healthy (Controls)United States