Changes in Physical FitnessTHINKNCT02932813
Translational Health After School Program on Health-Related Knowledge/Behaviors and Exercise Perception
A study testing THINK Program in people with Changes in Physical Fitness and Changes in Diet, Food, and Nutrition Habits, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in Physical Fitness, Changes in Diet, Food, and Nutrition Habits, Changes in Child Health
- What is being tested?
- THINK Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2017to 30 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in grades 3-5 (aged 8-12)
- enrolled in a YMCA after-school program
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Changes in Physical Fitness, Changes in Diet, Food, and Nutrition Habits, Changes in Child Health
- Being tested
- THINK Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THINK ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: THINK Program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Resting Measures
Resting heart rate and blood pressure will be assessed using an automatic blood pressure cuff.
Measured: Baseline, at 4 months, and at 9 months
Aerobic fitness
An NIH 2 minute walk test will be used to assess aerobic fitness.
Measured: Baseline, at 4 months, and at 9 months
Agility and speed
A shuttle run will be used to assess agility and speed.
Measured: Baseline, at 4 months, and at 9 months
Upper-body strength and endurance
A hand-grip dynamometer will be used to assess upper body strength and endurance
Measured: Baseline, at 4 months, and at 9 months
Abdominal strength and endurance
A one minute curl-up (sit up) will be used to assess abdominal strength and endurance.
Measured: Baseline, at 4 months, and at 9 months
Lower body power
The height of a vertical jump test will be used to assess lower body power.
Measured: Baseline, at 4 months, and at 9 months
Flexibility
A lower body sit and reach test will be used to assess flexibility.
Measured: Baseline, at 4 months, and at 9 months
Secondary outcomes (5)
Body Composition
Electrical impedance and 3 site Skinfolds
Measured: Baseline, at 4 months, and at 9 months
Body fat distribution
Waist and hip circumference will be measured
Measured: Baseline, at 4 months, and at 9 months
Exercise Enjoyment and Confidence
A modified Exercise Enjoyment Scale and a modified Exercise Self-Confidence Scale will be given
Measured: Baseline, at 4 months, and at 9 months
Knowledge/Behaviors/Habits
International Physical Activity Questionnaire (IPAQ) and The CATCH Kids Club questionnaire will be given.
Measured: Baseline, at 4 months, and at 9 months
Nutritional survey
A parental survey of family nutrition behaviors will be given and An Exercise Physiology and Nutrition Knowledge Base Test
Measured: Baseline, at 4 months, and at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start30 Jan 2017
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Physical FitnessStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Sherman Fairchild Foundation
- Responsible party
- Principal investigator, Arlette Perry, University of Miami
- Investigators
- Arlette Perry, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932813
- Sponsor's protocol ID
- 20160719
- Acronym
- THINK
- Status last verified
- Oct 2017
- First submitted
- 1 Sep 2016
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Translational Health After School Program on Health-Related Knowledge/Behaviors and Exercise Perception in Minority Children
- ClinicalTrials.gov ID
- NCT02932813
- Acronym / sponsor ID
- THINK / 20160719
- Conditions
- Changes in Physical Fitness, Changes in Diet, Food, and Nutrition Habits, Changes in Child Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Sherman Fairchild Foundation
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: THINK ProgramTHINK 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children in grades 3-5 (aged 8-12)
- enrolled in a YMCA after-school program
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THINK ProgramLessons 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
Agility and speed
Time frame: Baseline, at 4 months, and at 9 months
A shuttle run will be used to assess agility and speed.
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
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.
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.
Flexibility
Time frame: Baseline, at 4 months, and at 9 months
A lower body sit and reach test will be used to assess flexibility.
5 secondary outcomes
Body Composition
Time frame: Baseline, at 4 months, and at 9 months
Body fat distribution
Time frame: Baseline, at 4 months, and at 9 months
Exercise Enjoyment and Confidence
Time frame: Baseline, at 4 months, and at 9 months
Knowledge/Behaviors/Habits
Time frame: Baseline, at 4 months, and at 9 months
Nutritional survey
Time frame: Baseline, at 4 months, and at 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlette Perry, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THINK Program in people with Changes in Physical Fitness and Changes in Diet, Food, and Nutrition Habits, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Measures (time frame: Baseline, at 4 months, and at 9 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.