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Pain and Weight Treatment: Development and Trial of PAW (PAW)

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ClinicalTrials.gov Identifier: NCT04046562
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Melissa Santos, Connecticut Children's Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity, Adolescent Pain, Chronic CBT Behavioral: PAW Behavioral: Pain Education Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain and Weight Treatment: Development and Trial of PAW
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
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.
Behavioral: PAW
Pain and Weight Treatment plus standard of care

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.
Behavioral: Pain Education
Pain Education plus standard of care




Primary Outcome Measures :
  1. Mean difference in session attendance between groups [ Time Frame: Through the 13 weeks that comprise fit5 ]
    The number of sessions of fit5 attended will be compared between the group attending PAW and those in the information control group.


Secondary Outcome Measures :
  1. The feasibility and acceptability of the PAW intervention will be examined Via exit interviews [ Time Frame: At the conclusion of the 13 weeks of the program ]
    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.

  2. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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)


  3. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  4. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  5. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  6. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  7. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  8. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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)


  9. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  10. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  11. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  12. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  13. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  14. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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


  15. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [ Time Frame: At the conclusion of the 13 weeks of the program ]

    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.




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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046562


Contacts
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Contact: Melissa Santos, PhD 860-837-6739 Msantos@connecticutchildrens.org

Locations
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United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Melissa Santos, PhD    860-867-6739    Msantos@connecticutchildrens.org   
Sponsors and Collaborators
Connecticut Children's Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Melissa Santos, PhD Connecticut Children's Medical Center

Additional Information:
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Responsible Party: Melissa Santos, Principal Investigator, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT04046562     History of Changes
Other Study ID Numbers: 14-079
1R21DK117221 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NA - we are not planning on sharing the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight