PAW for Childhood Obesity

(PAW Trial)

Overseen By Melissa Santos, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Must not be taking: Weight reducing

Disqualifiers: Severe psychiatric illness, Type 1 diabetes

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if addressing pain can improve weight management in children with obesity. The study tests a program called PAW (Pain and Weight management), which combines pain management with standard weight loss care, to assess its effectiveness in helping children adhere to their treatment plan and maintain healthy habits. Teens aged 12-18 in a weight management program who experience significant pain, such as musculoskeletal pain, may be suitable candidates for this trial. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance future care for children with obesity and pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on weight reducing medications.

What prior data suggests that these treatments are safe for pediatric obesity management?

Research has shown that the PAW (Pain, Awareness, and Weight management) method is being tested to help children with obesity by focusing on managing pain to improve weight control. Specific safety data from these studies is not available. However, the study is labeled as "Not Applicable" for the clinical trial phase, indicating the treatment is considered safe enough to test without early safety trials.

The PAW method incorporates standard care practices, building on treatments for childhood obesity that are already widely accepted. This suggests it is likely safe, as these standard treatments are generally well-tolerated by children.

In summary, while direct safety data is unavailable, the trial phase and use of standard treatments suggest that PAW is likely safe for children in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAW program for childhood obesity because it integrates pain management with weight management strategies, offering a holistic approach not typically seen in current treatments. Unlike standard care, which often focuses solely on diet and exercise, PAW incorporates cognitive and behavioral skills training, helping kids understand the connections between their pain, eating habits, and physical activity. This comprehensive method aims to empower children with the tools needed for long-term success, potentially leading to more sustainable lifestyle changes and improved outcomes compared to conventional methods.

What evidence suggests that PAW might be an effective treatment for pediatric obesity?

Research has shown that programs like PAW, which help manage weight in children and teens, can lead to a small reduction in body weight for those with obesity. A study with 6,454 young participants demonstrated the effectiveness of these programs in weight management. In this trial, one group will receive PAW sessions, which combine pain management strategies with traditional weight management methods, such as maintaining diaries for pain, food, and exercise. This approach aims to address both obesity and related issues like pain, which can hinder the adoption of healthy habits. Evidence from similar programs suggests that tackling these issues together can enhance weight loss efforts. Meanwhile, another group will receive pain education sessions, focusing on general pediatric pain management without behavioral or cognitive skills training. ^{2 4 6 7 8}

Who Is on the Research Team?

Melissa Santos, PhD

Principal Investigator

Connecticut Children's Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 12-18 with obesity, experiencing musculoskeletal pain, and enrolled in a weight management program. They must score above 3 on the Pain Burden Inventory, indicating significant pain. Parents or guardians must consent to participate but can't join if they have Type 1 diabetes, are on weight loss meds, or have severe psychiatric issues.

Inclusion Criteria

You are currently participating in a program to manage your weight.

Your pain score is higher than 3 on the Pain Burden Inventory, showing that you have more than just normal aches and pains.

Signed consent and assent from the child and parent

Exclusion Criteria

I am currently taking medication to lose weight.

You have Type 1 diabetes.

You have a serious mental illness, such as feeling very depressed or needing to stay in the hospital for mental health reasons in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

A focus group will be held to review the PAW curriculum

1 week

Treatment

Participants undergo a 13-week Fit5 program with a 4-session adjunctive CBT intervention for those with musculoskeletal pain

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Exit Interviews

Exit interviews to obtain preliminary feasibility, acceptability, and retention data on PAW

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Pain Education
• PAW

Trial Overview

The PAW (Pain and Weight Treatment) study tests whether addressing chronic pain alongside obesity treatment improves outcomes for kids. It involves PAW therapy combined with standard care versus just standard care which includes education about managing pain.

How Is the Trial Designed?

Group I: PAW plus standard of care Active Control 1 Intervention

Each PAW session will include handouts and worksheets to assist with new strategies as well as homework. Strategies taught within PAW will be integrated with the skills taught in weight management. For example, pain diaries will be kept along with food and exercise logs to examine relationships among pain, eating and activity.

Group II: Pain education plus standard of care Placebo Group 1 Intervention

For those randomized into the information-only group, sessions will be delivered in the same manner. Sessions will cover general pediatric pain management but no behavioral or cognitive skills training will be taught.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

About one-third of children with obesity in kindergarten experienced remission by eighth grade, indicating that some children can naturally overcome obesity without formal weight loss programs.

Persistent remission of obesity was observed in 21.6% of children, with factors like being female and having a high socio-economic status initially linked to this outcome, although these links weakened when considering initial BMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remission of obesity among a nationally representative sample of US children. Luan, D., Mezuk, B., Bauer, KW.[2022]

In a study of 6454 children and adolescents with obesity, participation in pediatric weight management programs led to a modest median decrease in body mass index (BMI), with significant improvements observed over 12 months.

Factors such as older age (≥12 years), greater severity of obesity, and Hispanic ethnicity were linked to better outcomes in BMI reduction, which also correlated with improvements in cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. Kumar, S., King, EC., Christison, AL., et al.[2020]

Surgical options for treating adolescent obesity have been shown to be both safe and effective, making them a viable treatment choice for severe cases.

To improve treatment outcomes, individualized protocols of varying intensity should be developed based on each patient's severity of obesity and risk factors, ideally through multidisciplinary clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric obesity. Holterman, MJ., Le Holterman, AX., Browne, AF.[2012]

A study involving 500 obese children and 150 healthy controls found that obesity is linked to increased thickness of epicardial adipose tissue (EAT) and carotid intima-media thickness (IMT), which are indicators of cardiovascular risk.

Obese children exhibited early signs of heart dysfunction, including changes in echocardiographic measurements and cardiac function indices, suggesting that obesity can lead to significant cardiovascular issues even at a young age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of epicardial adipose tissue, carotid intima-media thickness and ventricular functions in obese children and adolescents. Alp, H., Eklioğlu, BS., Atabek, ME., et al.[2016]

A comprehensive evaluation of obese children and adolescents should include assessments of weight, body fat, and potential underlying health issues, as well as risk factors for diseases like diabetes and hypertension.

Successful obesity treatment involves setting realistic goals, promoting a balanced low-fat/high-fiber diet, achieving a safe weight loss of 1-2 pounds per week, increasing physical activity, and providing strong parental support along with behavior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of childhood obesity in pediatric practice. Williams, CL., Campanaro, LA., Squillace, M., et al.[2019]

A multidisciplinary pediatric weight management program showed a small but significant decrease in BMI z-score among high-risk children after 9 months, indicating some improvement in weight status.

The program also led to significant improvements in cardiovascular risk factors, such as total cholesterol and triglyceride levels, highlighting its effectiveness in addressing obesity-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pediatric weight management program for high-risk populations: a preliminary analysis. Skelton, JA., DeMattia, LG., Flores, G.[2009]

Children with obesity often do not have appropriate drug dosing guidelines, leading to increased risks of adverse events and challenges for healthcare providers in managing their care.

The study emphasizes the need for well-designed pharmacokinetic (PK) trials and collaboration with the FDA to improve drug labeling and dosing information for this vulnerable population, which could significantly enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. Zimmerman, KO., Benjamin, DK., Becker, ML., et al.[2023]

In a study of 2977 American Indian children and adolescents, higher body mass index (BMI) percentiles were linked to increased blood pressure, higher fasting plasma glucose, and unfavorable cholesterol levels, indicating a higher cardiometabolic risk.

Longitudinal analysis showed that as BMI percentiles increased over time, there were corresponding increases in fasting glucose, 2-hour glucose, and triglycerides, along with a decrease in HDL cholesterol, highlighting the importance of monitoring BMI for health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk profile based on body mass index in American Indian children and adolescents. Wheelock, KM., Fufaa, GD., Nelson, RG., et al.[2018]

In a study of 445 Native Canadian children and adolescents, the prevalence of overweight was significantly higher than national averages, with 27.7% of boys and 33.7% of girls classified as overweight.

Increased television viewing (more than 5 hours per day) and lower fitness levels were strongly associated with a higher risk of overweight, while higher fiber intake was linked to a reduced risk, highlighting the importance of lifestyle factors in obesity prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overweight among children and adolescents in a Native Canadian community: prevalence and associated factors. Hanley, AJ., Harris, SB., Gittelsohn, J., et al.[2018]

The European Medicines Agency (EMA) has received only four pediatric investigation plans for treating childhood obesity, highlighting the limited development of obesity medications for children.

Challenges in these plans often relate to patient population characteristics, trial design, and safety considerations, emphasizing the need for clinical trial protocols that align with European guidelines before starting pediatric trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of pharmacological treatment of obesity in children. A European regulatory perspective. Karres, J., Tomasi, P., Saint Raymond, A.[2016]

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