Pain and Weight Treatment: Development and Trial of PAW

Pain, Chronic Clinical Trial

— PAW  

Official title:

Pain and Weight Treatment: Development and Trial of PAW

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046562
• Other study ID #: 14-079
• Secondary ID: 1R21DK117221
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Connecticut Children's Medical Center
• Contact: Melissa Santos, PhD
• Phone: 860-837-6739
• Email: Msantos[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Childhood obesity is a major public health crisis in the United States, affecting 16.9% of youth aged 2-19 and 20.5% of youth aged 12-19. While current family-based interventions are effective in reducing body mass index (BMI) in adolescents; the majority of adolescents regain their excess weight within 2 years. In addition, there is a high rate of drop out from weight management programs, with 27% to 73% of families not completing the full treatment protocol. One possible mechanism influencing pediatric weight management outcomes is chronic pain. Although chronic pain affects 25 to 46% of all youth, among youth with obesity, the prevalence is upwards of 70%. The causal relationship between pain and obesity is not well understood. In some cases, chronic pain may be a precipitant that causes youth to develop obesity by limiting their activities or altering their eating habits. A more common scenario is that obesity places mechanical stresses on the body that can cause pain. With time, pain may become "centralized." Either mechanism may impact youth's participation in a weight management program. However, interventions that address the relationship between chronic pain and obesity in youth are needed, yet no such interventions exist. We expect that co-treating these conditions -obesity and pain- rather than treating just the obesity, will lead to improved pediatric weight management outcomes. The proposed study will take place at the Pediatric Obesity Center at Connecticut Children's Medical Center (CCMC), as an adjunct to our Fit5 program. Fit5 is CCMC's family-based, group weight management treatment program for youth between the ages of 10-18. Consisting of 13 sessions, this multidisciplinary program focuses on behavior changes, nutrition education and physical activity within a cognitive behavioral therapy (CBT) framework. A brief 4 session adjunctive CBT intervention, Pain and Weight treatment (PAW), will be trialed in a group of youth entering weight management treatment and endorsing musculoskeletal pain. This will be done in three phases. First a focus group will be held to review the PAW curriculum which has already been created for this study. In phase two, a small randomized (n = 25 per condition) controlled trial (RCT) will be conducted to pilot PAW. Finally, exit interviews to obtain preliminary feasibility, acceptability and retention data on PAW as compared to an information only control condition will be conducted. There is much work that continues to be needed to improve treatment for youth with obesity. The findings of this study will advance a line of research much needed to better understand outcomes and treatment for adolescents with obesity by shifting from focusing on obesity as an independent condition, and instead, treating it in the context of its comorbid conditions that may be important determinants of engagement, adherence, and outcomes. This proposal will focus on pain and obesity as a model with the intention that this could expand to other comorbidities such as sleep disturbances. The pilot data obtained through this R21 grant proposal will be used to modify the intervention and to seek R01 funding to support a large scale RCT of PAW.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• CBT
• Chronic Pain
• Obesity, Adolescent
• Pain, Chronic
• Pediatric Obesity

Intervention

Behavioral:
• PAW
Pain and Weight Treatment plus standard of care
• Pain Education
Pain Education plus standard of care

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The feasibility and acceptability of the PAW intervention will be examined Via exit interviews	At the exit interviews, we 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.	At the conclusion of the 13 weeks of the program
Secondary	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)	At the conclusion of the 13 weeks of the program
Secondary	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	At the conclusion of the 13 weeks of the program
Secondary	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	At the conclusion of the 13 weeks of the program
Secondary	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 Adolescent Pediatric Pain Tool	At the conclusion of the 13 weeks of the program
Secondary	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.; Self-confidence: Readiness Ruler	At the conclusion of the 13 weeks of the program
Secondary	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: Eating Behaviors Questionnaire	At the conclusion of the 13 weeks of the program
Secondary	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.; Behavior: The Pediatric Symptom Checklist 17 item (PSC-17)	At the conclusion of the 13 weeks of the program
Secondary	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.; Quality of life: Sizing me up	At the conclusion of the 13 weeks of the program
Secondary	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.; Quality of life: Sizing them up	At the conclusion of the 13 weeks of the program
Secondary	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 Child Activity Limitations Interview questionnaire	At the conclusion of the 13 weeks of the program
Secondary	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 Child Activity Limitations Interview questionnaire Parent version	At the conclusion of the 13 weeks of the program
Secondary	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: Pain Burden Interview	At the conclusion of the 13 weeks of the program
Secondary	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.; Sleep: Adolescent Sleep-Wake Scale	At the conclusion of the 13 weeks of the program
Secondary	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.; Medical: Youth will have their height, weight, BMI and BMI z-score calculated pre and post program completion as well as an assessment of their medical comorbidities.	At the conclusion of the 13 weeks of the program

External Links

•   Dr. Santos' Obesity Website