NCT06602076: ECHO

Developing an Empowerment Theory-Based Smoking Cessation Intervention for People With High Levels of Social Stress

Withdrawn EARLY_PHASE1 Last updated 5 May 2026

What this trial tests

EARLY_PHASE1 trial testing ECHO (Empowering Our Community & Health Outcomes) in Smoking Cessation. Withdrawn.

Timeline

1 August 2026

Primary endpoint
1 July 2027

1 July 2027

Quick facts

Lead sponsor	University of Oklahoma
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Start date	1 August 2026
Primary completion	1 July 2027
Estimated completion	1 July 2027

Drugs / interventions tested

• ECHO (Empowering Our Community & Health Outcomes)

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

University of Oklahoma

Who can join

Adults 18 to 100, any sex, with Smoking Cessation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Retention
  Time frame: 12 weeks
  BENCHMARK: Retention at week 12 (minimum 80%)
• Intervention feasibility
  Time frame: 12 weeks
  The following post-intervention outcome will be assessed at Week 12: Overall intervention feasibility will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater feasibility. BENCHMARK: Intervention feasibility at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
• Intervention acceptability
  Time frame: 12 weeks
  The following post-intervention outcome will be assessed at Week 12: Overall intervention acceptability will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater acceptability. BENCHMARK: Intervention acceptability at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).
• Intervention appropriateness
  Time frame: 12 weeks
  The following post-intervention outcome will be assessed at Week 12: Overall intervention appropriateness will be assessed by the Weiner scale (2017), which has four 5-point Likert-scale questions; higher score indicates greater appropriateness. BENCHMARK: Intervention appropriateness at Week 12 (70% or more of participants with an average score of 4 or greater on each scale).

Sponsor's own description

Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relapse within 6 months of a quit attempt. Existing smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than socioenvironmental influences on cessation success. Cessation interventions based on evidence linking social stress to increased nicotine dependence and relapse risk are needed to address the stressors people who smoke encounter while navigating their social environments (i.e., social stress). Effective empowering approaches for infectious disease prevention and youth tobacco use suggest that Empowerment Theory may also enhance smoking cessation assistance for people experiencing high levels of social stress.

Hypothesis: Our hypothesis is that when people participate in community-serving volunteer activities, they may also experience cognitive and behavioral changes (i.e., enhanced stress coping, social support, self-worth, prosociality) that ameliorate the effects of social stress, thereby supporting smoking cessation.

Importance: Empowerment Theory-informed health behavior change approaches have worked for infectious disease prevention and youth tobacco interventions. Our pretest (N=20; Oklahoma) demonstrated the feasibility and acceptability of volunteer activity participation as an adjunct to standard smoking cessation treatment. This novel smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community engagement. To ensure scalability and accessibility of this remotely delivered intervention, we will utilize the NIH-supported Dissemination and Implementation (D\&I) science framework, the Practical, Robust Implementation and Sustainability Model (PRISM), which is the contextually expanded version of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance). This project will advance efforts to understand and address high tobacco use among people experiencing high levels of social stress and will inform a future R01 application for a fully-powered, multi-site RCT of ECHO aiming to end tobacco use across the U.S. while supporting community connectedness.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.