A randomized clinical trial of an integrated behavioral self-management intervention Simultaneously Targeting Obesity and Pain: the STOP trial

BACKGROUND: Obesity often occurs co-morbid with chronic, non-cancer pain. While behavioral treatments have proved effective for pain management and weight loss independently, integrated interventions are lacking. The study Simultaneously Targeting Obesity and Pain (STOP) is a prospective, pragmatic, randomized controlled trial that aims to determine whether overweight/obese individuals with chronic pain who are randomized to receive an integrated treatment Simultaneously Targeting Obesity and Pain (STOP) will show more weight loss and greater reduction in pain intensity over a 6-month period and greater maintenance at 12 months than those who receive standard care behavioral weight loss or standard care behavioral pain management. We hypothesize that individuals randomized to receive the STOP treatment will demonstrate improved weight loss, pain reduction, and maintenance compared to standard care treatment approaches. METHODS/DESIGN: Adults aged ≥ 18 with a body mass index ≥ 25 and who report persistent pain (≥4 out of 0–10 for > 6 months) will be recruited for treatment at the Health Behavior Research Lab at the University of the Sciences. After baseline assessments and goal setting, participants will be randomized to receive one of three treatments. Participants will receive eleven treatment sessions delivered during 1 hour, weekly individual meetings with a clinic therapist. Follow-up will occur at 3, 6 and 12-month time points; assessments will include measures of weight and pain intensity (primary outcomes). A mixed-method approach to evaluating study outcomes will include individual interviews with participants about their treatment experience. These interviews will be led by a research staffer who was not involved in study intervention or assessment using a semi-structured discussion guide. DISCUSSION: This study fills an important gap in intervention research, evaluating best-practices for behavioral management of a highly prevalent co-morbidity that has sub-optimal outcomes with currently-implemented approaches. STOP’s pragmatic focus builds upon treatments already in use in clinical practice. Should STOP be found efficacious in achieving the dual outcomes of pain management and weight loss, such an approach could be integrated into practice with minimal additional cost or training. TRIAL REGISTRATION: Clinical Trials.gov NCT02100995 Date of Registration: March 2014