Pain and Weight Treatment: Development and Trial of PAW

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Contact Information
Primary
Melissa Santos, PhD
Msantos@connecticutchildrens.org
860-837-6739
Time Frame
Start Date: 2019-08-14
Estimated Completion Date: 2026-05
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Connecticut Children's Medical Center

This content was sourced from clinicaltrials.gov