Exercise + Nutrition for Obesity

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how exercise and dietary changes can improve heart and metabolic health in teens with obesity. Researchers seek to determine whether exercising, increasing fruit and vegetable intake, or combining both offers the greatest health benefits. Participants will be divided into four groups to test these approaches. Teens who are not very active and consume fewer fruits and vegetables may be well-suited for this study.

As an unphased trial, this study provides a unique opportunity for teens to contribute to important research that could lead to healthier lifestyle recommendations.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that intense exercise improved body shape and reduced insulin problems in teenagers with severe obesity. These results suggest that exercise is generally safe and well-tolerated for them. Another study found that engaging in aerobic exercise for at least 150 minutes a week significantly reduced waist size and body fat without causing serious side effects.

Research has also shown that dietary changes can be effective and safe. One study found that increasing fruit and vegetable intake helped lower body mass index (BMI) and fat consumption. Importantly, no evidence of serious harm emerged from these dietary changes.

Combining exercise with a healthy diet might offer even greater benefits. Studies have shown that this combination can further reduce body fat and improve overall health, again without major safety concerns.

Overall, both exercise and dietary changes appear safe for teenagers with obesity, based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these interventions for obesity because they offer a holistic approach that integrates both exercise and nutrition into the standard care framework. Unlike typical obesity treatments that often focus on medication or surgery, these interventions emphasize lifestyle changes. The exercise intervention provides structured, supervised sessions that help participants build a consistent routine, while the nutritional intervention enriches diets with a variety of fruits and vegetables, aiming to improve overall health. The combined approach is especially promising because it addresses multiple aspects of obesity, potentially leading to more sustainable weight loss and better long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that exercise can greatly reduce body fat and waist size in people with obesity. In this trial, participants may join an exercise intervention arm, engaging in a 12-week exercise program. Studies suggest that exercising for at least 150 minutes a week can lead to significant changes in body shape.

Participants in the nutritional intervention arm will receive dietary coaching and participate in a 12-week dietary program enriched with fruits and vegetables. Learning about nutrition and combining it with exercise has been linked to noticeable weight loss and improved body measurements.

Additionally, some participants will join an arm that combines both exercise and nutritional interventions, which has been shown to enhance these benefits. Short-term programs that include both exercise and healthy eating have effectively helped people with obesity lose weight and improve their health. ^{2 4 6 7 8}

Who Is on the Research Team?

Elisabet Borsheim, Ph.D

Principal Investigator

Arkansas Children's Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828487

Aerobic Exercise and Weight Loss in Adults: A Systematic ... Aerobic exercise at least 150 minutes per week was associated with clinically important reductions in waist circumference and measures of body fat.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37084486/

A systematic review on the effectiveness of diet and ... The ADF participants achieved body weight change of mean -0.9% ± 0.6% in the low-weight-loss group, and -9.9% ± 1.1% in the high-weight-loss ...

3. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... This meta-analysis of 14 RCTs found that interventions lasting 6 months or less were effective at achieving weight loss. Each study showed ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2212267214010557

Diet or Exercise Interventions vs Combined Behavioral ... Pooled results showed that weight loss at 3 to 6 months was significantly higher in combined programs than in those that involved physical activity alone (mean ...

5. mdpi.com mdpi.com/1660-4601/18/5/2635

Effects of Exercise Interventions on Weight, Body Mass ... The exercise interventions were effective in reducing visceral fat (d = −1.08 (95% CI, −1.60–−0.57; p < 0.001; k = 5)) in overweight and obese individuals.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK539893/

Exercise and Fitness Effect on Obesity - StatPearls - NCBI - NIH Researchers have proposed that exercise is an important lifestyle measure to maintain a healthy weight. This review will cover the role of exercise in obesity ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000348

Effect and safety of a physical exercise-based intervention ... High-intensity exercise program improved body composition and insulin resistance in adolescents with severe obesity (SOb). •. Adolescents with SOb responded ...

8. nature.com nature.com/articles/s41366-025-01860-z

Effects of weight control interventions on cardiovascular ... Bariatric surgery was consistently associated with reduced risks for all cardiovascular outcomes except atrial fibrillation. For dietary ...