Simultaneously Targeting Obesity and Pain: The STOP Trial (STOP)
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|ClinicalTrials.gov Identifier: NCT02100995|
Recruitment Status : Unknown
Verified April 2016 by Elizabeth Amy Janke, University of the Sciences in Philadelphia.
Recruitment status was: Recruiting
First Posted : April 1, 2014
Last Update Posted : April 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity Chronic Pain||Behavioral: Intervention Simultaneously Targeting Obesity and Pain Behavioral: Weight Loss/Weight Self-Management Behavioral: Chronic Pain Self-Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial of an Integrated Behavioral Self-management Intervention Simultaneously Targeting Obesity and Pain: The STOP Trial|
|Estimated Primary Completion Date :||January 2017|
Experimental: STOP Intervention
The STOP treatment includes content designed to simultaneously and explicitly target both chronic pain and obesity. Treatment components are drawn from evidence-based interventions for chronic pain and obesity, separately.
Behavioral: Intervention Simultaneously Targeting Obesity and Pain
Active Comparator: Standard Care Weight (SCW)
The weight loss intervention includes content focused around nutrition and eating habits, stimulus control and behavioral change, and physical activity. This content has been chosen because of its demonstrated effectiveness and importance in behavioral interventions to reduce weight.
Behavioral: Weight Loss/Weight Self-Management
Active Comparator: Standard Care Pain (SCP)
The chronic pain intervention is focused around reconceptualization of pain, decreasing catastrophizing, and increasing self-efficacy for pain. This content has been chosen because of its demonstrated effectiveness and importance in non-pharmacological interventions to improve pain management.
Behavioral: Chronic Pain Self-Management
- Change in weight from baseline to 12-months [ Time Frame: Baseline, up to 12 months ]Body weight measured using a calibrated digital scale during assessment visits.
- Change in pain intensity from baseline to 12 months [ Time Frame: Baseline, up to 12 months ]Pain intensity as measured on a numeric ratings scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).
- Change in pain disability from baseline to 12 months [ Time Frame: Baseline, up to 12 months ]As measured by West Haven Yale Multidimensional Pain Inventory (WHYMPI).
- Change in quality of life from baseline to 12 months [ Time Frame: Baseline, up to 12 months ]As measured by the SF-36.
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): NCT02100995
|Contact: Madelyn Ruggieriemail@example.com|
|Contact: Research Assistant(s)|
|United States, Pennsylvania|
|University of the Sciences||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Elizabeth A Janke, PhD||University of the Sciences in Philadelphia|