Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time.
Status:
Suspended
Trial end date:
2022-05-31
Target enrollment:
Participant gender:
Summary
The study has two phases. In Phase 1, the investigators will revise and pilot the distress
tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20
GM103430, Spas, PI). Despite the 4-week post-intervention treatment outcomes demonstrating
the DT protocol's association with smoking cessation and weight loss, several revisions to
the DT protocol are important to improve the intervention. First, the investigators will
include the overweight/obese smokers' group-level feedback that the investigators collected
during the 7-week intervention and at the 4-week post-intervention individual interviews to
tailor the DT protocol to meet the unique needs of smokers with excess weight. Subjects from
the previous study revealed factors that led to current and/or previous successful smoking
cessation and weight loss efforts, barriers to sustaining current and/or previous successful
smoking cessation and weight loss efforts, and general feedback about DT intervention for
both health risks. The investigators believe revising the DT protocol to include
overweight/obese smokers' unique experience with the novel intervention and their acumen
about these key factors will improve the intervention and its generalizability to smokers
with excess weight. Additional revisions are described elsewhere. After the investigators
pilot the revised DT protocol, the investigators will revise the active health control
protocol comprised of standard treatment for smoking cessation and weight loss to ensure both
protocols equate for intervention contact time. Although both protocols will have some
similar content, to avoid any threats to internal validity, no DT-specific material will be
included in the control. In Phase 2, the investigators will conduct a two-armed, preliminary
randomized controlled trial (RCT) to compare the revised DT protocol's efficacy to the active
health control protocol.