Pain and Weight Treatment: Development and Trial of PAW
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorConnecticut Children's Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PAW
BehavioralPain and Weight Treatment plus standard of care
Pain Education
BehavioralPain Education plus standard of care
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PAW plus standard of careActive comparator 1 intervention
Group B: Pain education plus standard of carePlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Through the 13 weeks that comprise fit5Secondary outcomes
1
The feasibility and acceptability of the PAW intervention will be examined Via exit interviews
At the exit interviews, the investigators will inquire with families whether 4 sessions felt sufficient, whether they would have liked more or less sessions and when they would have liked sessions scheduled.
Time frame
At the conclusion of the 13 weeks of the program2
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Depressed mood: The Center for Epidemiological Studies Depression Scale for Children (CES-DC)
Time frame
At the conclusion of the 13 weeks of the program3
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Eating behaviors (EAH): Three Factor Eating Questionnaire - R18
Time frame
At the conclusion of the 13 weeks of the program4
The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires.
Although not powered to be able to detect clinically significant differences pre and post program completion, as part of standard of care families complete a battery of measures prior to and after their completion in the fit5 program. Family scores on these responses will be examined to see if trends show changes in a meaningful and clinically relevant direction. Pain symptoms: The Pain Frequency - Severity - Duration Scale
Time frame
At the conclusion of the 13 weeks of the programSponsors and contacts
Click on the lead sponsor to view all of their trials.
Connecticut Children's Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov