Obesity, AdolescentPAWNCT04046562
Pain and Weight Treatment: Development and Trial of PAW
A study testing PAW and Pain Education in people with Obesity, Adolescent and Pain, Chronic, run by Connecticut Children's Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Obesity, Adolescent, Pain, Chronic, CBT
- What is being tested?
- PAW and Pain Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Melissa Santos, PhD, 860-867-6739, Msantos@connecticutchildrens.org
About this study
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.
Read the 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. 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.
- Conditions
- Obesity, Adolescent, Pain, Chronic, CBT
- Being tested
- PAW, Pain Education
- Medical subject headings
- Pediatric Obesity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAWBehavioural
Pain and Weight Treatment plus standard of care
Pain EducationBehavioural
Pain Education plus standard of care
| Study group | Role | What they receive |
|---|---|---|
| PAW plus standard of care | Active comparator | 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. Receives: Behavioral: PAW |
| Pain education plus standard of care | Placebo comparator | 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. Receives: Behavioral: Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the 13 weeks that comprise fit5
Secondary outcomes (15)
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.
Measured: At the conclusion of the 13 weeks of the program
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)
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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)
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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
Measured: At the conclusion of the 13 weeks of the program
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.
Measured: At the conclusion of the 13 weeks of the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start14 Aug 2019
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Santos, Connecticut Children's Medical Center
- Investigators
- Melissa Santos, PhD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046562
- Sponsor's protocol ID
- 14-079
- Other IDs
- 1R21DK117221
- Acronym
- PAW
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NA - the investigators are not planning on sharing the data
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Weight Treatment: Development and Trial of PAW
- ClinicalTrials.gov ID
- NCT04046562
- Acronym / sponsor ID
- PAW / 14-079
- Conditions
- Obesity, Adolescent, Pain, Chronic, CBT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PAW plus standard of care | Active comparator | Behavioral: PAWEach 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. |
| Pain education plus standard of care | Placebo comparator | Behavioral: Pain EducationFor 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAWPain and Weight Treatment plus standard of care | Behavioural | PAW plus standard of care |
| Pain EducationPain Education plus standard of care | Behavioural | Pain education plus standard of care |
Primary outcome
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.
15 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Dr. Santos' Obesity WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. NA - the investigators are not planning on sharing the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Santos, PhD principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAW and Pain Education in people with Obesity, Adolescent and Pain, Chronic, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Santos, PhD (860-837-6739, Msantos@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in session attendance between groups (time frame: Through the 13 weeks that comprise fit5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.