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NCT Number: NCT04046562

Pain and Weight Treatment: Development and Trial of PAW

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.

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Key information

Conditions

Obesity, Adolescent Body Weight CBT Chronic Pain Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location status: Recruiting

Location contact

Melissa Santos, PhD

CONTACT

[email protected]

860-867-6739

About this study

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. The investigators 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAW

Behavioral

Pain and Weight Treatment plus standard of care

Pain education

Behavioral

Pain Education plus standard of care

Primary outcomes

  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 outcomes

  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, 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.

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Santos, PhD

CONTACT

[email protected]

860-837-6739

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: PAW

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2019
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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