ObesityNCT03182621
Comprehensive Versus Traditional Lifestyle Program
A study testing THINK and SPARK in people with Obesity and Physical Fitness, run by University of Miami.
Trial summary
Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Obesity, Physical Fitness, Cognitive Function 1, Social
- What is being tested?
- THINK and SPARK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2014
- 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
- No healthy volunteers
- Child
Who may be able to join
- To be eligible for this study, subjects had to be between the ages of eight and 12, enrolled in a YMCA program, and able to participate in physical activity. Parents were provided with information packets regarding project details, a parental consent form, and a child assent form. Once the subjects assented and parents consented, a health questionnaire regarding child's age, gender, race/ethnicity, health history and SES was completed.
Who cannot join
- Subjects with metabolic, cardiovascular, neuromuscular and psychological disorders and with medications that would interfere with testing results were excluded from the study.
About this study
Official title: THINK (Translational Health in Nutrition and Kinesiology) Junior Edition
Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a 10-week intervention period.
Read the detailed description
Despite recommendations that school-based interventions use a comprehensive approaches for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 predominantly, ethnic minority children (9±1.03 years old) following a 10week intervention period.
- Conditions
- Obesity, Physical Fitness, Cognitive Function 1, Social
- Being tested
- THINK, SPARK
- Keywords
- Physical Fitness, Body Composition, Executive Cognitive Function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THINKBehavioural
The THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities.
SPARKBehavioural
traditional YMCA program
| Study group | Role | What they receive |
|---|---|---|
| THINK | Experimental | The Translational Health in Nutrition and Kinesiology (THINK) program will have education and fitness sessions lasting two hours, five times a week for a total of 10 weeks. 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 |
| SPARK | Active comparator | This The Sports, Play, and Active Recreation for Kids (SPARK) group will receive the traditional YMCA SPARK after-school program. They will undergo the same pre and post testing protocol as the intervention group, but will not receive the THINK program. Receives: Behavioral: SPARK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aerobic Fitness
The National Institute of Medicine Toolbox two-minute Walk Endurance Test was used to measure aerobic fitness
Measured: Baseline and 10 Weeks
Change in Grip Strength
Grip strength was measures using a Jamar plus handgrip dynamometer.
Measured: Baseline and 10 Weeks
Change in Abdominal Strength
The one-minute curl-up test was used to measure abdominal strength and endurance.
Measured: Baseline and 10 Weeks
Change in Lower Body Strength
Lower body strength, specifically for the quadriceps muscle group, was assessed with the wall squat test. A vertical jump test utilizing a Vertec. was used to assess lower body power . The vertical jump test data were used to estimate average power (W) according to the Lewis formula Average Power (W) = √4.9 x mass (kg) x √VJ (m) x 9.81.
Measured: Baseline and 10 Weeks
Change in Percent Body Fat
Body composition and body fat was measured using the Inbody-520 multi-frequency bioimpedance analyzer.
Measured: Baseline and 10 Weeks
Change in BMIz
A CDC growth chart statistical resource was used to calculate BMIz using height, weight, age, and gender.
Measured: Baseline and 10 Weeks
Change in Visceral Abdominal Fat
The Saggital Abdominal Height was used as estimate of visceral abdominal fat using a portable anthropometer.
Measured: Baseline and 10 Weeks
Change in Waist circumference
Waist circumference was used to measure central adiposity with a Gulick body tape measure.
Measured: Baseline and 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee
- 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
- NCT03182621
- Sponsor's protocol ID
- 20120486
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only the study investigators and/or sponsor will monitor the plan for data and safety monitoring for this study. Shared data will be done through encrypted files and file management platform OneDrive.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THINK (Translational Health in Nutrition and Kinesiology) Junior Edition
- ClinicalTrials.gov ID
- NCT03182621
- Acronym / sponsor ID
- 20120486
- Conditions
- Obesity, Physical Fitness, Cognitive Function 1, Social
- Keywords
- Physical Fitness, Body Composition, Executive Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- University of Tennessee
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Jun 2017 (actual)
- 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.
Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a 10-week intervention period.
Detailed description
Despite recommendations that school-based interventions use a comprehensive approaches for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 predominantly, ethnic minority children (9±1.03 years old) following a 10week intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THINK | Experimental | Behavioral: THINKThe Translational Health in Nutrition and Kinesiology (THINK) program will have education and fitness sessions lasting two hours, five times a week for a total of 10 weeks. 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. |
| SPARK | Active comparator | Behavioral: SPARKThis The Sports, Play, and Active Recreation for Kids (SPARK) group will receive the traditional YMCA SPARK after-school program. They will undergo the same pre 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
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- To be eligible for this study, subjects had to be between the ages of eight and 12, enrolled in a YMCA program, and able to participate in physical activity. Parents were provided with information packets regarding project details, a parental consent form, and a child assent form. Once the subjects assented and parents consented, a health questionnaire regarding child's age, gender, race/ethnicity, health history and SES was completed.
Key exclusion criteria (1 listed)
- Subjects with metabolic, cardiovascular, neuromuscular and psychological disorders and with medications that would interfere with testing results were excluded from the study.
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 |
|---|---|---|
| THINKThe THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities. | Behavioural | THINK |
| SPARKtraditional YMCA program | Behavioural | SPARK |
Primary outcome
Change in Aerobic Fitness
Time frame: Baseline and 10 Weeks
The National Institute of Medicine Toolbox two-minute Walk Endurance Test was used to measure aerobic fitness
Change in Grip Strength
Time frame: Baseline and 10 Weeks
Grip strength was measures using a Jamar plus handgrip dynamometer.
Change in Abdominal Strength
Time frame: Baseline and 10 Weeks
The one-minute curl-up test was used to measure abdominal strength and endurance.
Change in Lower Body Strength
Time frame: Baseline and 10 Weeks
Lower body strength, specifically for the quadriceps muscle group, was assessed with the wall squat test. A vertical jump test utilizing a Vertec. was used to assess lower body power . The vertical jump test data were used to estimate average power (W) according to the Lewis formula Average Power (W) = √4.9 x mass (kg) x √VJ (m) x 9.81.
Change in Percent Body Fat
Time frame: Baseline and 10 Weeks
Body composition and body fat was measured using the Inbody-520 multi-frequency bioimpedance analyzer.
Change in BMIz
Time frame: Baseline and 10 Weeks
A CDC growth chart statistical resource was used to calculate BMIz using height, weight, age, and gender.
Change in Visceral Abdominal Fat
Time frame: Baseline and 10 Weeks
The Saggital Abdominal Height was used as estimate of visceral abdominal fat using a portable anthropometer.
Change in Waist circumference
Time frame: Baseline and 10 Weeks
Waist circumference was used to measure central adiposity with a Gulick body tape measure.
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 9 Jun 2017.
- Individual participant dataSharing planned: Yes. Only the study investigators and/or sponsor will monitor the plan for data and safety monitoring for this study. Shared data will be done through encrypted files and file management platform OneDrive.
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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
Questions about this trial
What is this clinical trial studying?
A study testing THINK and SPARK in people with Obesity and Physical Fitness, run by University of Miami.
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 1 inclusion and 1 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 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Aerobic Fitness (time frame: Baseline and 10 Weeks). The study lists 8 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 9 Jun 2017.