Asthma and Obesity Diet Versus Exercise

NCT03644355 | Completed DMC

• 1 other identifier: LSUHSC IRB 7437
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is recognized as a pro-inflammatory condition associated with multiple chronic diseases, including asthma. The specific mechanisms linking asthma and obesity remain hypothetical. Our primary hypothesis is that inflammatory SNPs may regulate the degree of the inflammatory response, with obesity modifying the severity of the disease. In this instance, asthma that develops in the context of obesity demonstrates the potential deleterious relationship between a specific proinflammatory state (obesity) and the genetic regulators of inflammation (SNPs). Our secondary hypothesis proposes that short-term (12-weeks) weight loss by diet alone, but not exercise alone, will reduce lung specific inflammation and diminish the pro-inflammatory responses in female African American obese adolescents with asthma compared to a waiting list control group who after their initial 12 weeks then receive a combined 12-week diet plus exercise program (waiting list control/combined). A third exploratory hypothesis proposes that the frequency of identified SNPs will be significantly related to the amount of fat loss through diet, exercise or combined program and will further be mediated by specific airway and, pro-and-anti-inflammatory markers.These hypotheses will be tested using the following Specific Aims:

1. 1.To determine the frequency of single nucleotide polymorphisms and SNP haplotypes in pro- and anti-inflammatory genes in female African American obese and non-obese asthmatic and non-asthmatic adolescents, 13-19 years or age.
2. 2.To examine the effects of diet or exercise on lung specific inflammation (exhaled nitric oxide, \[eNO\]) and pro-and-anti-inflammatory responses in female African-American obese asthmatic and non-asthmatic adolescents compared to a waiting list control/ combined group.

Conditions

Obesity, Childhood; Asthma in Children; Inflammatory Response; Metabolic Syndrome; Nutrition Poor; Physical Activity; Behavior, Eating; Molecular Biology, Restriction Fragment Length Polymorphisms; Maternal Exposure; Genetic Change

Outcome Measures

Primary Outcomes (1)

• exhaled nitric oxide, [eNO] change

  Exhaled nitric-oxide (eNO; to be performed at baseline visit and post intervention at 13 to 15 weeks): The eNO level will be measured by chemiluminescence gas analyzer (Niox®), standardized according to the American Thoracic Society guidelines, 1999 \[29\]. NO is produced in healthy airway for normal physiologic functions (maintaining airway patency). It is formed during airway inflammation and may contribute to oxidative stress. It is overproduced in the lungs of asthmatic patient. Evidence suggests that eNO may be used as marker for lung inflammation \[30-33; 112\].

  Baseline visit and and post intervention at 13 to 15 weeks

Secondary Outcomes (10)

• Body Mass Index Change

  Baseline visit and and post intervention at 13 to 15 weeks

• Single nucleotide polymorphisms (SNPs)

  Baseline clinical visit

• Arginase activity

  Baseline clinical visit

• myeloid-derived suppressor cells (MDSC)

  Baseline clinical visit

• Serum inflammatory markers change

  Baseline visit and and post intervention at 13 to 15 weeks

Study Arms (4)

Diet and Nutrition Education

EXPERIMENTAL

Lifestyle counseling plus nutrition education and counseling and protein sparing modified fast diet plus supplementation of vitamins and minerals, followed by a balanced, hypo-caloric diet and nutrition education provided by a registered dietician

Behavioral: Lifestyle counseling

Exercise Instruction

ACTIVE COMPARATOR

Lifestyle counseling plus moderate intensity, progressive exercise prescription including cardio-pulmonary, strength and flexibility exercise tailored to the individual needs of each participant.

Behavioral: Lifestyle counseling

Combined Diet and Exercise

ACTIVE COMPARATOR

Lifestyle counseling plus dietary intervention including nutrition education and counseling and a protein sparing modified fast diet and nutrition education combined with the exercise intervention including a moderate intensity, progressive exercise prescription including cardio-pulmonary, strength and flexibility exercise tailored to the individual needs of each participant.

Behavioral: Lifestyle counseling

Control

NO INTERVENTION

Delayed intervention (waiting list) group receives no intervention for 12 weeks followed by the Diet plus Exercise intervention.

Interventions

Lifestyle counseling BEHAVIORAL

Inter-disciplinary, interactive, family based behavioral intervention for overweight children

Also known as: Trim Kids Behavioral Counseling Intervention

Combined Diet and Exercise; Diet and Nutrition Education; Exercise Instruction

Eligibility Criteria

• Age: 13 Years - 19 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• African American Females with an age of 13-19 years will be recruited. Our aim is to target high school age youth who are most likely to exhibit autonomy and authority to control both their nutrition and exercise regimens. In addition this age range is representative of the age group most likely to access school based health centers for recruitment purposes. Lastly, the study includes the collection of blood samples for the purpose of examining varied physiologic parameters that are affected by maturation. Participants above the age of 13 are most likely pubertal and thus, less likely to be affected by maturation issues.

You may not qualify if:

• Presence of other chronic pulmonary or systemic disease.
• Presence of moderate or severe atopic dermatitis or allergic rhinitis.
• Severe asthmatic based upon American Thoracic Society (ATS) standards and/or NIH guidelines.
• Acute lower respiratory infection in the last 2 weeks before baseline eNO evaluation.
• Pregnant are nursing mothers Study participants and parents (s) will be advised of the known risks and consequences associated with the testing and also of the reasonably known risks and consequences of not undergoing testing.
• Severe or uncontrolled asthmatics will not be allowed to participate.
• Participants with a recent (in the last 2 weeks) lower respiratory infection will not be allowed to participate.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome; Malnutrition; Motor Activity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior; Behavior, Animal

Study Officials

• Melinda S Sothern, PhD

  Louisiana State University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Cross-sectional, randomized controlled trial

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: August 23, 2018
• Study Start: May 19, 2010
• Primary Completion: August 4, 2016
• Study Completion: August 4, 2016
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)