Recruiting

PAW

Sponsor:

Connecticut Children's Medical Center

Code:

NCT04046562

Conditions

Obesity, Adolescent

Pain, Chronic

CBT

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

PAW

Pain Education

Study Details

Brief summary:

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.

Conditions

Obesity, Adolescent

Pain, Chronic

CBT

Study ID

NCT04046562

Start date

Aug 14, 2019

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and females between 12 and 18 years of age
  • Ability to speak, write and read English
  • A parent or guardian who speaks, writes and reads English
  • Signed consent and assent from the child and parent
  • Enrollment in a weight management program
  • Score greater than 3 on the Pain Burden Inventory at screening (in order to recruit adolescents who experience more than just general aches and pains).
  • Youth reporting musculoskeletal pain

Exclusion Criteria:

  • Parent or guardian unable to participate
  • Patients on weight reducing medications
  • Severe psychiatric illness (i.e., suicidal or hospitalization within past 6 months)
  • Medical conditions such as Type 1 diabetes

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PAW plus standard of care

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.

placebo comparator: Pain education plus standard of care

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.

Interventions

PAW

Pain and Weight Treatment plus standard of care

Pain Education

Pain Education plus standard of care

Primary outcome measure

  • Mean difference in session attendance between groups [ Time Frame: Through the 13 weeks that comprise fit5 ]

Central Contacts and Locations

Central contacts

Melissa Santos, PhD

860-837-6739Msantos@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Melissa Santos, PhD

860-867-6739Msantos@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-07-01.