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Exercise to Enhance Smoking Cessation for Women at the YMCA

6 juin 2012 mis à jour par: The Miriam Hospital

Using a YMCA Exercise Program to Enhance Nicotine Dependence Treatment for Women

Approximately 21% of women continue to smoke cigarettes despite the increased risk of cancer and cardiovascular disease associated with cigarette smoking. Exercise has been shown to be an efficacious treatment component in combating nicotine dependence, especially among women for whom concerns about weight gain during smoking cessation are an obstacle to successful quitting. In previous trials of women smokers, the investigators program of cognitive behavioral smoking cessation treatment (CBT) plus regular aerobic exercise was more efficacious than CBT plus equal contact time. Recognizing the program's successes, Commit to Quit (CTQ) was recently designated an Effective Program by the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Effective Programs. Thus, the Commit to Quit program is well poised for a larger trial in a community setting where it has the potential to reach a large number of female smokers in a setting in which it can be sustained. In response to PA-03-126, Behavioral Therapies Development Program, the investigators propose a Stage III study in which they will conduct a trial to test the investigators CTQ smoking cessation program in the community setting of the local YMCAs. As stated in the PA, Stage III research is aimed at understanding if and how an efficacious therapy may be transported to the community. The investigators propose a randomized controlled clinical trial to take place in the YMCA setting and delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise to CBT smoking cessation treatment plus contact control. In order to promote transportability to the YMCA, the investigators will use the YMCA's existing Personal Fitness Program, which is similar to the investigators CTQ exercise program, in that it is guided by trained staff and requires participants to exercise 3 times per week. If the exercise condition is found to be more efficacious than contact control when delivered at the YMCA by YMCA staff, then the investigators will be well positioned to partner with the YMCA to pursue widespread, national dissemination of this program.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

We propose a randomized controlled clinical trial to take place in the YMCA setting and to be delivered by YMCA staff. The trial will compare CBT smoking cessation treatment plus a program of regular exercise (CBT + EXERCISE) to CBT smoking cessation treatment plus an equal staff contact control (CBT + CONTACT). In order to promote transportability to the YMCA, the exercise program will be the YMCA's existing Personal Fitness Program, which like our CTQ exercise program, is guided by trained staff and requires participants to exercise at least 3 times per week.

If CBT + EXERCISE is found to be more efficacious than CBT + CONTACT when delivered at the YMCA by YMCA staff, then we will be well positioned to partner with the YMCA's initiative of Y Total Health to pursue widespread, national dissemination of this program. The proposed testing of the efficacy of the CTQ program in the YMCA setting is a necessary intermediate step in the eventual dissemination of the CTQ program.

Primary Aim. To determine the efficacy of CBT + EXERCISE compared with CBT + CONTACT when delivered in the YMCAs by YMCA staff to enhance the achievement and maintenance (3, 6, and 12 months follow-up) of smoking cessation (continuous abstinence) among healthy adult female smokers.

Hypothesis. Participants in the CBT + EXERCISE condition will have significantly greater continuous abstinence rates than those in the CBT + CONTACT condition at end-of-treatment, 3, 6, and 12 months follow-up.

Additional Questions of Interest.

1. To perform process-to-outcome analyses on the intermediate variables which influence the achievement and maintenance of smoking cessation among healthy female smokers. Specifically, to determine if exercise affects weight and/or weight concerns, negative affect associated with nicotine withdrawal, and/or self-efficacy and to determine if these hypothesized mediators affect the achievement and maintenance of smoking cessation.

To explore potential moderators of the treatment, such as baseline demographic and psychological characteristics (e.g., age, baseline mood) on smoking cessation outcomes.

Type d'étude

Interventionnel

Inscription (Réel)

408

Phase

  • Phase 2
  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • The Mriam Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Healthy female smokers
  • ages 18 - 65
  • Read and write English
  • Regularly smoke 5 or more cigarettes a day
  • Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than once a week or greater than 30 minutes of moderate exercise 2 times per week.

Exclusion Criteria:

  • known history of cardiovascular
  • pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension, chronic bronchitis, asthma, emphysema, and diabetes
  • Any musculoskeletal problems that would limit exercise training such as knee or hip osteoarthritis or any other serious medical condition that might make exercise unsafe or unwise.
  • The current use of smokeless tobacco, nicotine replacement therapy or other smoking cessation treatment, and currently using prescription medication that might impair exercise performance or tolerance, specifically beta-blockers or medications used for the treatment of hypertension
  • Pregnant or planning to become pregnant within the next 12 months.
  • Women hospitalized for a psychiatric disorder
  • Receiving treatment for bipolar disorder or schizophrenia
  • Current alcohol abuse or psychological problems when quitting in the past that required treatment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: CBT+ Contact
In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.
Comportemental: CBT+ Contact
In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.
Expérimental: CBT+ Exercise
Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.
Comportemental: CBT+ Exercise
Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Salivary Cotinine
Délai: 12 months posttreatment
Saliva will be collected at the 12 month follow-up visit and sent to a laboratory for analysis of cotinine, a biomarker of nicotine.
12 months posttreatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Miriam Hospital

Collaborateurs

National Institute on Drug Abuse (NIDA)

Les enquêteurs

  • Chercheur principal: Bess H Marcus, PhD, The Miriam Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2006

Achèvement primaire (Réel)

1 septembre 2010

Achèvement de l'étude (Réel)

1 avril 2012

Dates d'inscription aux études

Première soumission

18 mai 2012

Première soumission répondant aux critères de contrôle qualité

6 juin 2012

Première publication (Estimation)

8 juin 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 juin 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 juin 2012

Dernière vérification

1 juin 2012

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • R01DA021729 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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