Pain and Weight Treatment: Development and Trial of PAW
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
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.
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 08/31/2019 |
প্রথম জমা দেওয়া: | 06/06/2019 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 08/04/2019 |
প্রথম পোস্ট: | 08/05/2019 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 09/29/2019 |
সর্বশেষ আপডেট পোস্ট: | 09/30/2019 |
আসল অধ্যয়ন শুরুর তারিখ: | 08/13/2019 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 02/28/2021 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 02/28/2021 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Behavioral: PAW plus standard of care
Behavioral: Pain education plus standard of care
পর্যায়
বাহু গ্রুপ
বাহু | হস্তক্ষেপ / চিকিত্সা |
---|---|
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 plus standard of care 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 plus standard of care Pain Education plus standard of care |
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 12 Years প্রতি 12 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | All |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | 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 |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Mean difference in session attendance between groups [Through the 13 weeks that comprise fit5]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. The feasibility and acceptability of the PAW intervention will be examined Via exit interviews [At the conclusion of the 13 weeks of the program]
2. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
3. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
4. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
5. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
6. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
7. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
8. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
9. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
10. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
11. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
12. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
13. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
14. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]
15. The feasibility and acceptability of the PAW intervention will be examined via self-report psychosocial questionnaires. [At the conclusion of the 13 weeks of the program]