Pain and Weight Treatment: Development and Trial of PAW

NCT04046562 | Recruiting DMC

• 2 other identifiers: 14-0791R21DK117221
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean difference in session attendance between groups

  The number of sessions of fit5 attended will be compared between the group attending PAW and those in the information control group.

  Through the 13 weeks that comprise fit5

Secondary Outcomes (15)

• The feasibility and acceptability of the PAW intervention will be examined Via exit interviews

  At the conclusion of the 13 weeks of the program

• The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.

  At the conclusion of the 13 weeks of the program

• The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.

  At the conclusion of the 13 weeks of the program

• The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.

  At the conclusion of the 13 weeks of the program

• The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.

  At the conclusion of the 13 weeks of the program

Study Arms (2)

PAW plus standard of care

ACTIVE COMPARATOR

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.

Behavioral: PAW

Pain education plus standard of care

PLACEBO COMPARATOR

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.

Behavioral: Pain Education

Interventions

PAW BEHAVIORAL

Pain and Weight Treatment plus standard of care

PAW plus standard of care

Pain Education BEHAVIORAL

Pain Education plus standard of care

Pain education plus standard of care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

Related Links

• Dr. Santos' Obesity Website

MeSH Terms

Conditions

Pediatric Obesity; Chronic Pain

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Melissa Santos, PhD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Santos, PhD

CONTACT

860-837-6739; Msantos@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to one of two arms. One arm is PAW plus standard of care and the second arm is pain education plus standard of care.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: August 6, 2019
• Study Start: August 14, 2019
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)