Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity

NCT02060279 | Completed Results

• 1 other identifier: 12-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Obesity

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

Outcome Measures

Primary Outcomes (3)

• Change in β-carotene

  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.

  6 months

• Waist to Height Ratio

  6 months

Study Arms (2)

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

Interventions

Lifestyle intervention and carotenoid supplements OTHER

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 carotenoid supplement; Lifestyle intervention and placebo

Lifestyle intervention and placebo OTHER

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.

Lifestyle intervention and carotenoid supplement; Lifestyle intervention and placebo

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8 years to 11 years at enrollment
• BMI percentile ≥ 95th percentile

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, United States

Location

Related Publications (1)

• 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.

  PMID: 28323947 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Sedentary Behavior

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Endocrine System Diseases; Hyperinsulinism; Behavior

Results Point of Contact

• Title: Dr. Amanda Lochrie
• Organization: Nemours Children's Specialty Care

alochrie@nemours.org

904-697-3698

Study Officials

• Amanda S Lochrie, PhD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

• Jose A Canas, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: February 12, 2014
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-02

Locations

US (1)