Faith Based Pilot Intervention to Reduce Tobacco Use Among Somali Males
1.1 In the last five years, representatives of WellShare International and the University of Minnesota have engaged a large community of Muslims of Somali descent in the Twin Cities of Minnesota in a community-academic research program to understand smoking and cessation behaviors. This followed research by WellShare International which discovered a smoking prevalence among Somali men of 44%, which is nearly three times that of the general population (14.4%) in Minnesota. More recently, pilot data from ecological momentary assessments (EMA) conducted by WellShare International and the University of Minnesota Program in Health Disparities Research before and during Ramadan, showed that the majority of smokers achieved spontaneous significant reductions in cigarettes smoked per day during Ramadan. Guided by the NIH Stage Based Intervention Development Model, this study aims to understand the processes underlying smoking reduction and cessation during Ramadan. The investigators plan to harness this knowledge and develop a culturally-tailored, faith-based smoking cessation intervention (Stage 1). The investigators also plan to assess the feasibility of the new culturally-tailored smoking cessation intervention by conducting a pilot study (Stage 2).
The study aims are as follows:
Aim 1: To develop a faith-based, community-informed innovative smoking cessation intervention for use with a Somali immigrant population in Minnesota:
Aim 2: To assess the feasibility of a faith-based smoking cessation intervention delivered via a mobile phone during the Ramadan period:
This pilot study will test a protocol for use of faith based text messages, as informed by the scholarly work of the Imams, Community Advisory Group (CAG) and focus groups conducted in Stage 1.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Minnesota
-
Minneapolis, Minnesota, 미국, 55412
- University of Minnesota
-
Minneapolis, Minnesota, 미국, 55414
- WellShare International
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Somali Male
- 18 years of age or older
- Can read either Somali or English (Non English Speaking Participants will be included)
- Current smokers defined as smoking ≥ 1 cigarette per day
- Self-report of smoking ≥ 100 cigarettes in their lifetime
- Willingness to use nicotine patch or other selected pharmacotherapy
- Possess a working mobile phone with texting
- Planning to fast during Ramadan
Exclusion Criteria:
- Currently using any form of smoking cessation service
- Any medical contraindication
- Current history or in past 6 months of a psychotic disorder
- Suicidal ideation
- Cognitive impairment
- Any other medical condition that, in the opinion of the investigator, may interfere with the patient's ability to successfully and safely complete the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Behavioral: Faith-Based messages
We will send faith-based messages one week prior to Ramadan and twice a day during Ramadan.
|
We will send out faith based text messages on a weekly basis for the one week prior to the start of Ramadan, then twice a day during the Ramadan period that will encourage smoking cessation and continue to encourage change of behavior.
The faith-based messages will be incorporated with messages drawn from the Smokefree.gov
Mobile Interventions QuitNowTXT Message Library.
These messages will be geared towards reminding the smokers that as Ramadan is coming closer they need to consider the effects that smoking may have on their health and should consider taking steps towards quitting.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participants Adherence to the Intervention
기간: 8 weeks
|
Real time smoking cravings and urges, as well as the number of cigarettes smoked in each time period, will be measured via ecological momentary assessment (EMA) in a sample of Muslim male smokers who are fasting during Ramadan.
Participants will be enrolled in this study if they are current smokers and are going to fast throughout Ramadan.
Analyses will use data collected via a RedCap survey at random time points (3 times per day, 2 times a week) during Ramadan.
In the analysis, 4 time blocks (pre sunrise [4:30am-9:00am], day time [9:01am-3:00pm], pre sunset [3:01pm-9:00pm] and breaking fast [9:01pm-4:29am]) will be used for analysis.
|
8 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
smoking cessation
기간: 8 weeks
|
CO breath test at week 4 and week 8
|
8 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Olamide Ojo-Fati, MD MPH, University of Minnesota
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FMCH-2017-25736
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Faith-Based messages에 대한 임상 시험
-
Emory UniversityNational Institute on Aging (NIA)완전한
-
University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)모병
-
Qazvin University Of Medical Sciences완전한
-
Qazvin University Of Medical Sciences알려지지 않은
-
New Jersey Institute of TechnologyChildren's Hospital of Philadelphia; National Eye Institute (NEI); Rutgers University; Salus...완전한