50 Participants Needed

PAW for Childhood Obesity

(PAW Trial)

MS
Overseen ByMelissa Santos, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Connecticut Children's Medical Center

What You Need to Know Before You Apply

What is the purpose of this trial?

Pediatric weight management efficacy is impacted by failure to complete treatment protocols and, for those that do complete treatment, a return to unhealthy behaviors. This project tests whether treating pain, a common comorbid condition to pediatric obesity, will enhance treatment. This study will generate results that can be translated into immediate improvements in care for families seeking treatment for pediatric obesity.

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.

Is the PAW treatment for childhood obesity safe for humans?

The research articles do not provide specific safety data for the PAW treatment or Pain Education for childhood obesity, but they highlight the importance of careful drug dosing and trial design to ensure safety in children with obesity.12345

What data supports the effectiveness of the treatment PAW for Childhood Obesity?

The research suggests that pediatric weight management programs, which often include components like behavior therapy and increased physical activity, can improve health outcomes such as BMI (a measure of body fat based on height and weight) and cardiovascular risk factors in children. These elements are likely part of the PAW treatment, indicating potential effectiveness.678910

Who Is on the Research Team?

MS

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
See 3 more

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.
See 1 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: PAW plus standard of careActive Control1 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 carePlacebo Group1 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.

Find a Clinic Near You

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

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.
Pediatric obesity.Holterman, MJ., Le Holterman, AX., Browne, AF.[2012]
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 (โ‰ฅ12 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.
Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER.Kumar, S., King, EC., Christison, AL., et al.[2020]
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.
Management of childhood obesity in pediatric practice.Williams, CL., Campanaro, LA., Squillace, M., et al.[2019]

Citations

Pediatric obesity. [2012]
Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. [2020]
Management of childhood obesity in pediatric practice. [2019]
Remission of obesity among a nationally representative sample of US children. [2022]
A pediatric weight management program for high-risk populations: a preliminary analysis. [2009]
Overweight among children and adolescents in a Native Canadian community: prevalence and associated factors. [2018]
Evaluation of epicardial adipose tissue, carotid intima-media thickness and ventricular functions in obese children and adolescents. [2016]
Product Labeling of Drugs Commonly Administered to Children and Adults with Obesity. [2023]
The development of pharmacological treatment of obesity in children. A European regulatory perspective. [2016]
Cardiometabolic risk profile based on body mass index in American Indian children and adolescents. [2018]
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