- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060279
Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
February 7, 2014 updated by: Amanda Lochrie, Nemours Children's Clinic
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 8 years to 11 years at enrollment
- BMI percentile ≥ 95th percentile
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle intervention and carotenoid supplement
|
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.
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.
|
Experimental: Lifestyle intervention and placebo
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participation rates, satisfaction with the intervention, responses from the qualitative interview post-intervention, and health and medical outcomes
Time Frame: 6 months
|
6 months
|
β-carotene, FABP4 and C16:1n7 palmitolate levels
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Macrophage expression of genes involved in lipid and lipoprotein metabolism and adipose deposition
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda S Lochrie, PhD, Nemours Children's Clinic
- Principal Investigator: Jose A Canas, MD, Nemours Children's Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
April 16, 2013
First Submitted That Met QC Criteria
February 7, 2014
First Posted (Estimate)
February 12, 2014
Study Record Updates
Last Update Posted (Estimate)
February 12, 2014
Last Update Submitted That Met QC Criteria
February 7, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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