Pain and Weight Treatment: Development and Trial of PAW

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT04046562
Status
Recruiting
Apply to this trial

Conditions

  • CBT
  • Obesity, Adolescent
  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • PAW — BEHAVIORAL
    Pain and Weight Treatment plus standard of care
  • Pain Education — BEHAVIORAL
    Pain Education plus standard of care

Study Details

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.

Key Dates

Start date
Aug 14, 2019
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106
Melissa Santos, PhD
[email protected]
860-867-6739

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By research site
Connecticut Children's Medical Center· Hartford, CT

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