ObesityNCT01681108
Childhood Obesity-A Study of Intervention
A study testing Lifestyle counseling in people with Obesity, run by Winthrop University Hospital at 1 site in United States.
Trial summary
The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for children and adolescents to lose weight and promote their self esteem in a fun atmosphere. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Dec 2011
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents between the ages of 8 and 16 years with a BMI > 85th%.
Who cannot join
- Children younger then 8 years of age or older then 16 years of age.
- Children with a BMI < 85th%
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
The purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for children and adolescents to lose weight and promote their self esteem in a fun atmosphere.
Read the detailed description
The Program will be divided into four areas: 1) Screening, 2) Implementation 3) Follow-up Post program, 4) Analysis
- Screening Children between the ages of 8-16 years of age whose BMI>85th% will be identified and screened. The parent and their child must agree to participate in the entire study. During the first three visits, a full medical evaluation will be performed and it will be determined if the potential patient meets study entry criteria. Body measurements, blood collection, family history, behavioral, cardiac, exercise and nutritional evaluations will take place. Glucose tolerance testing will be performed during screening. if HbA1c is above 5.2 to classify patients as euglycemic, hyperinsulinemic or Type 2 Diabetes. Other endocrine evaluations (e.g. FSH, LH, testosterone, Total T4, Free T4, andandT3, TSH for PCOS and/or thyroid hormone dysfunction) will be performed as medically indicated. And if medical problems are present, they there will be addressed and treated by an appropriately medical treatment. In case of PCOS medical treatment is not enough and diet and exercise should be always part of the treatment.
- Program Implementation Participants will be entered into the 10-week program. Each child will act as his/her own control and the success of the interventions will be measured in change in percentiles over time. Each group will contain no more than 12 participants. During the program there will be intensive nutrition, behavioral and exercise therapy designed specifically for each child and for each family participating. The program, designed for a total of 32 weeks, will include weekly sessions for the first 10 weeks, every other week for the next 10 weeks, and once a month thereafter.
The design of the intervention is as follows:
- Individualized meal planning and exercise regimen sessions will be developed for each participant. .
- Participants and their families will participate in groups of 10 to 12 where they can elicit support and motivation from one another, learn about nutrition, behaviors as well as engage in exercise programs which are facilitated by a certified instructor.
- Weekly topics will be taught through 'gaming activities' designed to impart educational information through games and activities. Group support activities will use affective techniques in order to elicit sharing of feelings.
- Each discipline involved- behavioral, nutritional and exercise physiology will design pre and post evaluation tools (in addition to maintaining histories on each participant) as well as lesson plans, gaming activities and affective techniques. Behavioral issues such as eating through boredom, stress, or loneliness, for example, might be addressed in varied ways weaved throughout the 2 ½ hr session, while portion control, appropriate food choices might be the nutritional topics covered that session and reviewed through gaming activities. The exercise portion of the lesson may address varied types of exercise to reduce stress and keep them busy and a yoga instructor may come that night to demonstrate other stress reduction techniques.
- Follow-up Post Program After the 32-week program, there will be follow-up visits in order to assess maintenance of weight loss. Questionnaires and visits at 2 months, 6 months, and 1 year after the program ends will evaluate long-term success.
Subsequent visits will occur every three months which is considered standard of care.
- Analysis: Pre 10 week session and post 10 week session the following evaluation tools and criteria will be evaluated: Weight, waist circumference, endurance, strength, flexibility, triceps caliper measurements as well as the YES evaluation. The Youth Evaluation Scale is a nationally standardized test. The YES evaluation is performed on ages 9 and > and evaluates areas such as: habits, knowledge, self esteem, depression, anxiety, family communications, lifestyle, structure and more.
After years 1 and 2, the study team will evaluate the effectiveness of the program as a whole and each individual component. Recommendations for design changes, as well as statistical information from all study members (i.e., behavioral, nutrition, exercise) will be analyzed to determine the advantages of certain treatment modalities in the effective treatment of childhood obesity.
- Conditions
- Obesity
- Being tested
- Lifestyle counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
Individualized meal planning and exercise regimen sessions will be developed for each participant
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Other | Individualized meal planning and exercise regimen sessions will be developed for each participant Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI will be measured
Data will be collected at routine office visits
Measured: 3 month interval over 1 year
Secondary outcomes (2)
Weight
Data will be collected at routine office visits
Measured: 3 month interval over 1 year
Height
Data will be collected at routine office visits
Measured: 3 month interval over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJun 2006
- Primary completionDec 2011
- Study completionDec 2011
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siham Accacha, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681108
- Sponsor's protocol ID
- 06304
- Status last verified
- Sep 2012
- First submitted
- 28 Mar 2011
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Obesity-A Study of Intervention
- ClinicalTrials.gov ID
- NCT01681108
- Acronym / sponsor ID
- 06304
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Sep 2012 (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 purpose of this study is to verify the usefulness of Healthy KIDS Program (HKP) for children and adolescents to lose weight and promote their self esteem in a fun atmosphere.
Detailed description
The Program will be divided into four areas: 1) Screening, 2) Implementation 3) Follow-up Post program, 4) Analysis
- Screening Children between the ages of 8-16 years of age whose BMI>85th% will be identified and screened. The parent and their child must agree to participate in the entire study. During the first three visits, a full medical evaluation will be performed and it will be determined if the potential patient meets study entry criteria. Body measurements, blood collection, family history, behavioral, cardiac, exercise and nutritional evaluations will take place. Glucose tolerance testing will be performed during screening. if HbA1c is above 5.2 to classify patients as euglycemic, hyperinsulinemic or Type 2 Diabetes. Other endocrine evaluations (e.g. FSH, LH, testosterone, Total T4, Free T4, andandT3, TSH for PCOS and/or thyroid hormone dysfunction) will be performed as medically indicated. And if medical problems are present, they there will be addressed and treated by an appropriately medical treatment. In case of PCOS medical treatment is not enough and diet and exercise should be always part of the treatment.
- Program Implementation Participants will be entered into the 10-week program. Each child will act as his/her own control and the success of the interventions will be measured in change in percentiles over time. Each group will contain no more than 12 participants. During the program there will be intensive nutrition, behavioral and exercise therapy designed specifically for each child and for each family participating. The program, designed for a total of 32 weeks, will include weekly sessions for the first 10 weeks, every other week for the next 10 weeks, and once a month thereafter.
The design of the intervention is as follows:
- Individualized meal planning and exercise regimen sessions will be developed for each participant. .
- Participants and their families will participate in groups of 10 to 12 where they can elicit support and motivation from one another, learn about nutrition, behaviors as well as engage in exercise programs which are facilitated by a certified instructor.
- Weekly topics will be taught through 'gaming activities' designed to impart educational information through games and activities. Group support activities will use affective techniques in order to elicit sharing of feelings.
- Each discipline involved- behavioral, nutritional and exercise physiology will design pre and post evaluation tools (in addition to maintaining histories on each participant) as well as lesson plans, gaming activities and affective techniques. Behavioral issues such as eating through boredom, stress, or loneliness, for example, might be addressed in varied ways weaved throughout the 2 ½ hr session, while portion control, appropriate food choices might be the nutritional topics covered that session and reviewed through gaming activities. The exercise portion of the lesson may address varied types of exercise to reduce stress and keep them busy and a yoga instructor may come that night to demonstrate other stress reduction techniques.
- Follow-up Post Program After the 32-week program, there will be follow-up visits in order to assess maintenance of weight loss. Questionnaires and visits at 2 months, 6 months, and 1 year after the program ends will evaluate long-term success.
Subsequent visits will occur every three months which is considered standard of care.
- Analysis: Pre 10 week session and post 10 week session the following evaluation tools and criteria will be evaluated: Weight, waist circumference, endurance, strength, flexibility, triceps caliper measurements as well as the YES evaluation. The Youth Evaluation Scale is a nationally standardized test. The YES evaluation is performed on ages 9 and > and evaluates areas such as: habits, knowledge, self esteem, depression, anxiety, family communications, lifestyle, structure and more.
After years 1 and 2, the study team will evaluate the effectiveness of the program as a whole and each individual component. Recommendations for design changes, as well as statistical information from all study members (i.e., behavioral, nutrition, exercise) will be analyzed to determine the advantages of certain treatment modalities in the effective treatment of childhood obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Other | Behavioral: Lifestyle counselingIndividualized meal planning and exercise regimen sessions will be developed for each participant |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children and adolescents between the ages of 8 and 16 years with a BMI > 85th%.
Key exclusion criteria (2 listed)
- Children younger then 8 years of age or older then 16 years of age.
- Children with a BMI < 85th%
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 |
|---|---|---|
| Lifestyle counselingIndividualized meal planning and exercise regimen sessions will be developed for each participant | Behavioural | Lifestyle counseling |
Primary outcome
BMI will be measured
Time frame: 3 month interval over 1 year
Data will be collected at routine office visits
2 secondary outcomes
Weight
Time frame: 3 month interval over 1 year
Height
Time frame: 3 month interval over 1 year
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 7 Sep 2012.
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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.
Siham Accacha, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Obesity, run by Winthrop University Hospital 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 1 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 7 Sep 2012. 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?
BMI will be measured (time frame: 3 month interval over 1 year). 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 7 Sep 2012.