Pediatric ObesityNCT02060279
Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
A study testing Lifestyle intervention and carotenoid supplements in people with Pediatric Obesity, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Lifestyle intervention and carotenoid supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8 years to 11 years at enrollment
- BMI percentile ≥ 95th percentile
Who cannot join
- Any major chronic diseases, cognitive impairments, or any organic cause of obesity
- any orthopedic or neuromuscular condition that prevents/impedes age-appropriate physical activity
- confirmed diagnosis of Prader-Willi syndrome
- any metal implants that would preclude subject from safely having the MRI procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-month Family-based, Intense Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity: A Pilot Study
This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants.
Read the detailed description
The spread of childhood obesity across all ethnic and socioeconomic classes in North America is alarming. The close link between morbid obesity and type II diabetes (T2DM) and in childhood is undisputed fact and recent statistics reported by the American Diabetes Association suggest that newly diagnosed cases are on the rise. The link between decreased exercise, increased calorie and fat intake, decrease intake of fruits and vegetables and increased frequency of T2DM are well established. Complications of child obesity include risks for heart disease, high cholesterol, high blood pressure, diabetes, and even some cancers. The lack of fruit and vegetable consumption may be responsible for specific nutrient deficiencies such as low β-carotene, which has recently been identified as an important regulator of body fat. Nemours and Wolfson Children's Hospital have taken the initiative to explore factors that contribute to childhood obesity including well controlled studies examining the effects of intensive nutritional and behavioral education, healthy eating and increased exercise as ways to help prevent the rise in childhood obesity. This study aims to institute an intensive 2 week in-patient intervention which will serve as a model for behavioral changes required in children and families to successfully address the rapid progression of obesity. We will administer a supplement of β-carotene and follow the changes in abdominal fat accumulation over six months. At the third week of intervention we will obtain a blood sample that will determine if any beneficial changes have already taken place in white blood cells that clear cholesterol from the arteries using genetic testing. At the end of the study we will compare the amount of abdominal fat that accumulates or decreases in each subject. An intensive educational program that leads to healthy eating and the habitual exercise for the whole family will help promote significant benefits in the rate of weight gain and delay the progression to diabetes.
- Conditions
- Pediatric Obesity
- Being tested
- Lifestyle intervention and carotenoid supplements, Lifestyle intervention and placebo
- Keywords
- Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Prevention, Behavioral research, Metabolic Syndrome, Metabolic Disease, Overnutrition, Nutrition Disorders, Overweight, Body weight, Insulin resistance, Carotenoids, Dietary Supplement, Physical fitness, Sedentary lifestyle
- Medical subject headings
- Pediatric Obesity, Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Syndrome, Metabolic Diseases, Overnutrition, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention and carotenoid supplementsOther
2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.
Lifestyle intervention and placeboOther
2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a gel-cap placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention and carotenoid supplement | Experimental | Not described Receives: Other: Lifestyle intervention and carotenoid supplements; Other: Lifestyle intervention and placebo |
| Lifestyle intervention and placebo | Experimental | Not described Receives: Other: Lifestyle intervention and carotenoid supplements; Other: Lifestyle intervention and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in β-carotene
Measured: 6 months
BMI Z-score
Body Mass Index (kg/m*2) was calculated using body mass and height. Body Mass Index z-scores were generated according to the U.S. Centers for Disease Control and Prevention reference criteria. Z-scores range from -3 to 3 and a z-score of 0 represents the population mean.
Higher z-score values indicate worse outcomes. The Centers for Disease Control has defined obesity as a z-score > 1.64 and overweight as a z-score > 1.04.
Measured: 6 months
Waist to Height Ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Lochrie, Nemours Children's Clinic
- Investigators
- Amanda S Lochrie, PhD, Principal investigator, Nemours Children's ClinicJose A Canas, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060279
- Sponsor's protocol ID
- 12-42
- Status last verified
- Feb 2024
- First submitted
- 16 Apr 2013
- Last updated
- 18 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Canas JA, Lochrie A, McGowan AG, Hossain J, Schettino C, Balagopal PB. Effects of Mixed Carotenoids on Adipokines and Abdominal Adiposity in Children: A Pilot Study. J Clin Endocrinol Metab. 2017 Jun 1;102(6):1983-1990. doi: 10.1210/jc.2017-00185.
PubMed 28323947
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month Family-based, Intense Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity: A Pilot Study
- ClinicalTrials.gov ID
- NCT02060279
- Acronym / sponsor ID
- 12-42
- Conditions
- Pediatric Obesity
- Keywords
- Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Prevention, Behavioral research, Metabolic Syndrome, Metabolic Disease, Overnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Posted 18 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants.
Detailed description
The spread of childhood obesity across all ethnic and socioeconomic classes in North America is alarming. The close link between morbid obesity and type II diabetes (T2DM) and in childhood is undisputed fact and recent statistics reported by the American Diabetes Association suggest that newly diagnosed cases are on the rise. The link between decreased exercise, increased calorie and fat intake, decrease intake of fruits and vegetables and increased frequency of T2DM are well established. Complications of child obesity include risks for heart disease, high cholesterol, high blood pressure, diabetes, and even some cancers. The lack of fruit and vegetable consumption may be responsible for specific nutrient deficiencies such as low β-carotene, which has recently been identified as an important regulator of body fat. Nemours and Wolfson Children's Hospital have taken the initiative to explore factors that contribute to childhood obesity including well controlled studies examining the effects of intensive nutritional and behavioral education, healthy eating and increased exercise as ways to help prevent the rise in childhood obesity. This study aims to institute an intensive 2 week in-patient intervention which will serve as a model for behavioral changes required in children and families to successfully address the rapid progression of obesity. We will administer a supplement of β-carotene and follow the changes in abdominal fat accumulation over six months. At the third week of intervention we will obtain a blood sample that will determine if any beneficial changes have already taken place in white blood cells that clear cholesterol from the arteries using genetic testing. At the end of the study we will compare the amount of abdominal fat that accumulates or decreases in each subject. An intensive educational program that leads to healthy eating and the habitual exercise for the whole family will help promote significant benefits in the rate of weight gain and delay the progression to diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention and carotenoid supplement | Experimental | Other: Lifestyle intervention and carotenoid supplements, Other: Lifestyle intervention and placebo |
| Lifestyle intervention and placebo | Experimental | Other: Lifestyle intervention and carotenoid supplements, Other: Lifestyle intervention and placebo |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 8 years to 11 years at enrollment
- BMI percentile ≥ 95th percentile
Key exclusion criteria (4 listed)
- Any major chronic diseases, cognitive impairments, or any organic cause of obesity
- any orthopedic or neuromuscular condition that prevents/impedes age-appropriate physical activity
- confirmed diagnosis of Prader-Willi syndrome
- any metal implants that would preclude subject from safely having the MRI procedure
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 intervention and carotenoid supplements2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water. | Other | Lifestyle intervention and carotenoid supplement, Lifestyle intervention and placebo |
| Lifestyle intervention and placebo2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a gel-cap placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water. | Other | Lifestyle intervention and carotenoid supplement, Lifestyle intervention and placebo |
Primary outcome
Change in β-carotene
Time frame: 6 months
BMI Z-score
Time frame: 6 months
Body Mass Index (kg/m*2) was calculated using body mass and height. Body Mass Index z-scores were generated according to the U.S. Centers for Disease Control and Prevention reference criteria. Z-scores range from -3 to 3 and a z-score of 0 represents the population mean. Higher z-score values indicate worse outcomes. The Centers for Disease Control has defined obesity as a z-score > 1.64 and overweight as a z-score > 1.04.
Waist to Height Ratio
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28323947Canas JA, Lochrie A, McGowan AG, Hossain J, Schettino C, Balagopal PB. Effects of Mixed Carotenoids on Adipokines and Abdominal Adiposity in Children: A Pilot Study. J Clin Endocrinol Metab. 2017 Jun 1;102(6):1983-1990. doi: 10.1210/jc.2017-00185.
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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.
Amanda S Lochrie, PhD principal investigator
Nemours Children's Clinic
Jose A Canas, MD principal investigator
Nemours Children's Clinic
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 intervention and carotenoid supplements in people with Pediatric Obesity, run by Nemours Children's Clinic 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 4 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 18 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 18 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 β-carotene (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060279, which also lists 1 linked publication.
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 18 Jul 2024.