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PAW for Childhood Obesity (PAW Trial)

N/A
Recruiting
Led By Melissa Santos, PhD
Research Sponsored by Connecticut Children's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females between 12 and 18 years of age
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through the 13 weeks that comprise fit5
Awards & highlights

PAW Trial Summary

This trial will test whether treating pain, a common condition among obese children, will improve treatment outcomes.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on behavioral therapy and education rather than medication, side effects may be minimal and could include discomfort from discussing personal experiences with pain or lifestyle changes.

PAW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 18 years old.

PAW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the 13 weeks that comprise fit5
This trial's timeline: 3 weeks for screening, Varies for treatment, and through the 13 weeks that comprise fit5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean difference in session attendance between groups
Secondary outcome measures
The feasibility and acceptability of the PAW intervention will be examined Via exit interviews
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.

PAW Trial Design

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 Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,016 Total Patients Enrolled
1 Trials studying Cognitive Behavioral Therapy
50 Patients Enrolled for Cognitive Behavioral Therapy
Connecticut Children's Medical CenterLead Sponsor
71 Previous Clinical Trials
31,464 Total Patients Enrolled
Melissa Santos, PhDPrincipal Investigator - Connecticut Children's Medical Center
Connecticut Children's Medical Center

Media Library

PAW Clinical Trial Eligibility Overview. Trial Name: NCT04046562 — N/A
Cognitive Behavioral Therapy Research Study Groups: PAW plus standard of care, Pain education plus standard of care
Cognitive Behavioral Therapy Clinical Trial 2023: PAW Highlights & Side Effects. Trial Name: NCT04046562 — N/A
PAW 2023 Treatment Timeline for Medical Study. Trial Name: NCT04046562 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this medical research endeavor?

"To be eligible for this trial, participants need to have chronic pain and must fall between the ages of 12 and 18. Fifty individuals will be accepted in total."

Answered by AI

Does this clinical research encompass those aged 18 or above?

"According to the qualifications listed, this trial is seeking participants aged 12 to 18. Notably, there are 183 studies targeting minors and a further 384 dedicated towards elderly individuals over 65 years old."

Answered by AI

Is this investigation still seeking participants?

"This is accurate. As found on clinicaltrials.gov, this medical research project began its recruitment process in August 2019 and was last updated in January 2023; the study seeks to enrol 50 participants at a single site."

Answered by AI

How many individuals are participating in the current research study?

"Yes, according to clinicaltrials.gov, this trial is still recruiting participants. The initial announcement was posted on August 14th 2019 and the last update made on January 22nd 2023. Around 50 patients are needed from one medical site for full recruitment of study subjects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pain and Weight Treatment: Development and Trial of PAW
Melissa Santos 2019. "Pain and Weight Treatment: Development and Trial of PAW". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04046562.
~9 spots leftby Apr 2025
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