Exercise + Nutrition for Obesity

Recruiting at 1 trial location

Overseen By Florêncio Sousa, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Must not be taking: Inhalers, Rescue inhalers

Disqualifiers: Diabetes, Asthma, Autism, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications. However, it mentions that certain pre-existing medical conditions or medications that could affect the study outcomes may lead to exclusion, so it's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment Exercise Intervention, Nutritional Intervention for obesity?

Research shows that combining exercise with a low-calorie, low-fat diet leads to significant weight loss in people with obesity. This combination also helps improve health factors related to obesity, like blood pressure and cholesterol levels, and supports long-term weight maintenance. ^{1 2 3 4 5}

Is the combination of exercise and nutrition safe for managing obesity?

Exercise and nutrition interventions are generally safe for managing obesity, with benefits like improved physical function, better metabolic health, and reduced risk of complications. Regular exercise combined with a nutritious diet can help maintain weight loss and improve overall health without significant safety concerns. ^{4 5 6 7 8}

How does the Exercise + Nutrition treatment for obesity differ from other treatments?

The Exercise + Nutrition treatment for obesity is unique because it combines physical activity with dietary changes, which together lead to significant weight loss and help maintain weight loss more effectively than either approach alone. This combination also improves overall health by preserving muscle mass and enhancing metabolic rate, making it a comprehensive approach to managing obesity. ^{1 2 4 5 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn how exercise and diet quality affect the health of adolescents with obesity. The main questions it aims to answer are: * Does exercise improve cardiometabolic health in adolescents with obesity? * Does enriching the diet with fruits and vegetables (FV) improve cardiometabolic health in adolescents with obesity? * Do exercise and FV diet together provide greater health benefits than either alone in adolescents with obesity? Researchers will compare four groups to see how exercise and diet impact health: * Standard Care Group: Receives the usual care for obesity. * Exercise Group: Receives weekly exercise coaching and participates in a 12-week exercise program. * Diet Group: Receives weekly dietary coaching and eats a diet enriched with fruits and vegetables for 12 weeks. * Combined Exercise and Diet Group: Receives both exercise and dietary programs, namely weekly exercise and dietary coaching, participation in a 12-week exercise program, and daily consumption of fruits and vegetables for 12 weeks. During the 12-week study, participants will attend three study visits to: * Provide blood, stool, and urine samples. * Answer questions about health, sleep, diet, and physical activity. * Undergo body scans to measure fat, lean, and bone mass. * Complete blood vessel function and liver fat content assessments. * Assess resting exergy expenditure. * Complete fitness tests. * Wear a fitness tracker to monitor physical activity and sleep patterns.

Research Team

Elisabet Borsheim, Ph.D

Principal Investigator

Arkansas Children's Research Institute

Eligibility Criteria

This trial is for adolescents with obesity. Participants should be willing to undergo exercise or dietary coaching, provide samples, and have their body composition and health monitored. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Medical release

Less than 60 min/day of moderate to vigorous physical activity

Newly enrolled in a weight management program

Exclusion Criteria

Parent/child refusal to have blood drawn

I use daily asthma inhalers to control my symptoms.

I use my asthma rescue inhaler more than twice a week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week program involving exercise, dietary coaching, or both, depending on group assignment

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exercise Intervention
• Nutritional Intervention

Trial Overview The study tests the effects of exercise, a diet rich in fruits and vegetables (FV), or both on cardiometabolic health in obese adolescents. It compares four groups: standard care, exercise only, FV diet only, and combined exercise plus FV diet over 12 weeks.

Participant Groups

Group I: Nutritional Intervention Experimental Treatment 1 Intervention

In addition to the standard of care, participants receive dietary coaching and engage in a 12-week daily dietary program enriched with a blend of fruits and vegetables.

Group II: Exercise intervention Experimental Treatment 1 Intervention

In addition to the standard of care, participants engage in exercise coaching and a 12-week exercise program, encompassing three 60-minute supervised sessions per week.

Group III: Exercise and Nutritional Intervention Experimental Treatment 2 Interventions

In addition to the standard of care, participants receive a combined exercise and dietary intervention, as described in the other two intervention arms.

Group IV: Control Active Control 1 Intervention

Participants receive the standard of care for treating Class I and II obesity.

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Findings from Research

Combining diet and exercise is essential for effective obesity treatment, as neither alone is sufficient; however, very-low-calorie diets can help maintain physical function during significant weight loss.

Long-term success in maintaining weight loss is heavily dependent on adopting regular exercise habits after dieting, highlighting the importance of promoting lifelong exercise practices for sustained weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during and after very-low-calorie dieting. Phinney, SD.[2018]

An exercise program is crucial for managing obesity, as it not only burns calories but also boosts metabolism and helps regulate appetite, potentially leading to reduced caloric intake.

Combining regular exercise with a nutritious diet can help preserve lean body weight and lower the risk of serious health complications associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of physical activity in the control of obesity. Allen, DW., Quigley, BM.[2021]

A 16-week multimodal intervention combining enjoyable physical activities and nutritional counseling significantly improved health outcomes in 18 obese children, including better body composition and metabolic profiles.

The program achieved over 80% attendance and enhanced physical fitness, demonstrating that a fun and respectful approach to exercise can effectively combat childhood obesity without strict caloric restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent Exercise Training Combined with Nutritional Counselling Improves Physical Function, Biochemical and Anthropometric Profiles in Obese Children: A Pilot Study. Cordellat, A., Padilla, B., Grattarola, P., et al.[2021]

Exercise has numerous benefits for individuals with obesity, including aiding in weight loss and improving cardiovascular health, but the direct impact on weight loss from exercise alone is modest, typically resulting in only a few kilograms of weight loss.

Physical activity is crucial for managing type 2 diabetes and preventing its complications, and a structured approach like the 5 A's strategy can help healthcare professionals effectively support patients in overcoming barriers to increasing their physical activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. Oppert, JM., Bellicha, A., Ciangura, C.[2021]

Effective management of obesity requires a combination of diet, exercise, behavioral support, and sometimes medication, highlighting the importance of a comprehensive approach to weight management.

Behavioral counseling techniques, such as self-monitoring and social support, are crucial for overcoming barriers to compliance and enhancing motivation for physical activity, which is essential for successful weight loss and maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the science: a focus on physical activity. Hills, AP., Byrne, NM.[2006]

References

1. Austria pubmed.ncbi.nlm.nih.gov

[Diet and physical activity in the treatment of obesity]. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Critical Reappraisal of the Role and Importance of Exercise Intervention in the Treatment of Obesity in Adults. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The effects of imposed sedentary behavior and exercise on energy intake in adolescents with obesity. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise during and after very-low-calorie dieting. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

The role of physical activity in the control of obesity. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Multicomponent Exercise Training Combined with Nutritional Counselling Improves Physical Function, Biochemical and Anthropometric Profiles in Obese Children: A Pilot Study. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity in management of persons with obesity. [2021]

8. China pubmed.ncbi.nlm.nih.gov

State of the science: a focus on physical activity. [2006]

9. England pubmed.ncbi.nlm.nih.gov

The effect of exercise on energy intake and body composition in overweight women. [2014]