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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

Must not have

Patients on weight reducing medications

Parent or guardian unable to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the 13 weeks that comprise fit5

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication to lose weight.

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My parent or guardian cannot take part in this.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the 13 weeks that comprise fit5

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean difference in session attendance between groups

Secondary study objectives

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.

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.

0 / 3Eligibility criteria met