- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01162577
Oklahoma Weight Concerns Quitline: a Randomized Cessation Trial (OKRCT)
Przegląd badań
Szczegółowy opis
Smoking and obesity are the two biggest contributors to preventable morbidity and mortality. They are usually thought of independently, but for many people are inter-related. Cessation-related weight gain and concerns about weight gain are common and negatively impact cessation efforts.
Between March 2008 and November 2008 smokers who called the OKHL were screened for the presence of weight concerns and asked if they would be interested in a study offering the chance to speak with a weight coach (WC). Interested individuals were transferred to a specially trained Quit Coach (QC) who provided informed verbal consent, collected additional baseline data, obtained a second verbal consent to be randomized and were then randomized using a pre-programmed automated randomization procedure. Groups were randomly assigned in blocks of 20 so that after every 20th person randomized, the cells would be balanced. Individuals were randomized into either the control group to receive the standard quitline only (the OKHL 5-call program), or into the intervention group to receive standard care with integrated weight content plus three calls with a weight coach. All participants were offered a total of five tobacco cessations calls, access to Web Coach, tailored emails with quitting tips, access to the inbound support line, mailed quit guides, and nicotine replacement therapy (NRT) for cessation as appropriate. For the intervention group, QCs and WCs integrated weight concerns topics and components of the tobacco treatments into their calls with the primary goal of smoking cessation. A 6-month follow-up survey was conducted by the Oklahoma Tobacco Research Center, University of Oklahoma Health Sciences Center to compare outcomes between intervention and control conditions. The primary outcome was the 30-day quit rate. Secondary outcomes were:
90 day abstinence, adherence to tobacco treatment, confidence in quitting or staying quit, confidence in controlling weight gain after quitting, change in physical activity, participant satisfaction, change in weight concerns, change in weight by quit outcomes
We hypothesized that relative to controls, the 'Weight2Quit' intervention would:
- increase cessation without excessive weight gain
- increase satisfaction with the OKHL
- increase call completion rate
- reduce weight concerns, and
- increase confidence in quitting without weight gain THE STANDARD QUITLINE CESSATION PROGRAM The 5 proactive calls provided to participants in the multiple call programs are scheduled by mutual agreement between each participant and his or her Quit Coach. The aim is to set a quit date within 15 days, schedule calls around that quit date, and complete all calls within three months of enrollment.
THE WEIGH2QUIT INTERVENTION The intervention was modeled on evidence-based methods to address maladaptive weight gain concerns that negatively impact quitting (Perkins, 2001). In this study, we adapted the original intensive, in-person group intervention described by Perkins for delivery via a telephone-based quitline. Participants randomized to the Weigh2Quit intervention were offered the standard OKHL cessation program (with integrated weight concerns content) plus 3 additional calls with a weight coach and specialized support materials. The mailed materials included a description of the rationale of the new program, educational information and worksheets (e.g. self-monitoring forms for tracking maladaptive thoughts about weight and body image and tracking alternative thoughts). Intervention counseling calls were designed to increase smoking cessation and
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Washington
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Seattle, Washington, Stany Zjednoczone, 98104
- Free & Clear
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Individuals were eligible for the study if they were age 18 or older, smoked at least 5 cigarettes per day, were willing to quit within 30 days from enrollment in the Helpline, were not pregnant or nursing, agreed to be in the study and randomized, agreed to the follow-up interview, provided a workable phone number with a secondary back-up number, had a BMI of at least 23 and reported having significant concerns about gaining weight with quitting.
Exclusion Criteria:
- Individuals were not eligible for the study if they had a BMI lower than 23 or were pregnant
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Intervetion
The intervention group received the 5 standard tobacco calls plus 3 weight calls with a weight coach to address weight concerns related to quitting smoking
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Standard Quitline plus weight coaching
Inne nazwy:
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Brak interwencji: Control
Participants in this arm received only the 5 standard tobacco calls
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
30 day abstinence
Ramy czasowe: 6 months
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No smoking in the past 30 days
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6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in weight
Ramy czasowe: 6 months
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Change in weight (pounds)between baseline and 6 months
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6 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Terry Bush, PhD, Free & Clear, Inc.
Publikacje i pomocne linki
Publikacje ogólne
- Bush T, Levine MD, Deprey M, Cerutti B, Zbikowski SM, McAfee T, Mahoney L, Beebe L. Prevalence of Weight Concerns and Obesity Among Smokers Calling a Quitline. J Smok Cessat. 2008 Dec 1;4(5):74-78. doi: 10.1375/jsc.4.2.74.
- Bush T, Levine MD, Beebe LA, Cerutti B, Deprey M, McAfee T, Boeckman L, Zbikowski S. Addressing weight gain in smoking cessation treatment: a randomized controlled trial. Am J Health Promot. 2012 Nov-Dec;27(2):94-102. doi: 10.4278/ajhp.110603-QUAN-238.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 0001 (Cancer Research Institute)
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Badania kliniczne na Weight Concerns
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University of North Carolina, Chapel HillWeight Watchers InternationalZakończonyNadwaga i otyłośćStany Zjednoczone
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Medical University of South CarolinaWeight Watchers InternationalZakończonyOtyłość | Nadwaga | Cukrzyca typu 2Stany Zjednoczone
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University of PennsylvaniaWeight Watchers InternationalZakończony
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University Hospital, GhentZakończony
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University of British ColumbiaZakończonyNadwaga i otyłość | Dieta KetogenicznaKanada
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The Miriam HospitalUniversity of Tennessee; Weight Watchers InternationalZakończony
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Walter Reed Army Medical CenterZakończony
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The Miriam HospitalZakończony
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Stanford UniversityNational Heart, Lung, and Blood Institute (NHLBI)ZakończonyOtyłośćStany Zjednoczone
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University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Zakończony