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Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity (Imagery)

2018년 11월 27일 업데이트: University of Arizona
Tobacco use among women now approaches that of men, with approximately 27 million women smokers in the United States alone. Women report greater difficulties quitting smoking and are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary practices and lack of physical activity, with 92% of smokers reporting at least one other health risk factor. Concerns surrounding weight gain, negative body image, and low self-efficacy, may be key factors affecting smoking cessation among weight-concerned women smokers. Guided imagery has been successfully employed in separate lines of inquiry to address physical activity, diet and smoking cessation. However, guided imagery has not been employed to target weight concerned women who smoke or to simultaneously target smoking, diet, and exercise behavior in a single intervention. The proposed study would be the first of its kind to create a theory-based, guided imagery intervention to assist weight-concerned women smokers to quit. The use of a mobile app offers an innovative approach to addressing the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and has the potential to reach large numbers of women smokers. The project aims to develop and test the feasibility of a mobile health application using guided imagery in order to increase smoking cessation among a population of weight-concerned women smokers.

연구 개요

상태

완전한

정황

상세 설명

SPECIFIC AIMS Tobacco use among women now approaches that of men, with approximately 27 million women smokers in the United States alone. Lung cancer is the leading cause of cancer death among women, and more than 180,000 women die of other illnesses linked to smoking annually. Women report greater difficulties quitting smoking and are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary practices and lack of physical activity, with 92% of smokers reporting at least one other health risk factor. The presence of multiple behavioral risk factors greatly increases the risk of developing many acute and chronic conditions.

Concerns about weight gain, negative body image, and lack of self-efficacy may be key factors affecting smoking, diet, and exercise behavior of women. Women smokers are less satisfied with their bodies, have lower self-esteem, and are more concerned about becoming overweight than non-smokers. Approximately 50% of women smokers report that concerns about body weight are reasons they do not quit. Research indicates that women report lower self-efficacy in quitting than men, especially women concerned about controlling their weight. These findings suggest that targeting weight concerns, body image, and self-efficacy to quit with weight-concerned women who smoke may be an effective intervention strategy. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping weight-concerned smokers to quit.

One cognitive approach, guided imagery, has been successfully employed in separate lines of inquiry to address body image concerns and self-efficacy in our three target behaviors-exercise, diet and smoking cessation. However, guided imagery has not been employed to target weight concerned women who smoke or to simultaneously target smoking, diet, and exercise behavior in a single intervention. The proposed study would be the first of its kind to create a theory-based, guided imagery intervention to assist weight-concerned women smokers to quit.

While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in-person, limiting the dissemination of guided imagery-based interventions to large populations. Mobile health applications (mobile apps) delivered via smart phones offer a unique channel through which to distribute imagery-based interventions. Mobile apps may enhance the use of guided imagery through the use of audio files. The app may allow guided imagery scripts to be tailored by the user, and flexibly administered at varying times (e.g., during nicotine cravings). This approach could be especially useful for women, who are more likely than men to use the Internet to obtain health information. The use of a mobile app offers an innovative approach to addressing the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and has the potential to reach large numbers of women smokers. If successful, a mobile application for guided imagery could be used to address other health behaviors as well. The present project aims to develop and test the feasibility of a mobile health application using guided imagery in order to increase smoking cessation among weight-concerned women smokers.

The Specific Aims for this study are to:

Aim 1. Develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among weight-concerned women smokers. Scripts incorporating imagery across these domains will be developed specifically for smoking cessation, eating a healthy diet and engaging in physical activity. The investigators will develop initial content and user interface ideas based on experience in using guided imagery for increasing physical activity, and using technology to assist tobacco cessation and healthy eating. Ten focus group participants (weight-concerned women smokers who own a smart phone, representing various racial/ethnic groups) will provide feedback on content, potential tailoring of content by race/ethnicity, functions, and design, which will inform development of the mobile app.

Aim 2. Program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features. Users will be able to customize certain elements of the application, and be required to provide input in response to app prompts. The investigators will conduct usability testing, observing 10 participants using "think aloud" procedures as they interact with the app, to ensure that it is fully functional and easy to use.

Aim 3. Evaluate the feasibility, acceptability, and preliminary efficacy of the app with 50 weight-concerned women smokers. The primary outcome will be self-reported tobacco abstinence at 3 months post-enrollment. The investigators will also measure: dietary intake; level of physical activity; body image; self-efficacy; cravings; and participants' use of the app, including the imagery scripts, diary, and resource links.

The potential impact of this proposed intervention is great, because it addresses behavioral risk factors that can be applied to populations beyond smokers. This proposal is significant because it intervenes with women smokers; innovative, in that it uses guided imagery to change lifestyle behaviors important for the prevention of chronic diseases, and, technology to maximize dissemination potential. The proposed investigation takes a theory-based approach, builds on the considerable track records of the investigators, and will be conducted in an environment highly suited for this study. Results of this study will be used to prepare for a future randomized controlled trial to test the efficacy and cost-effectiveness of a multi-behavioral, guided imagery mobile health application versus a single smoking cessation imagery mobile health application.

연구 유형

중재적

등록 (실제)

166

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

여성

설명

Inclusion Criteria include the following:

  • Must be female
  • Report smoking in the past 30 days
  • Use an Android cell phone
  • Have a valid email address
  • Have a valid phone number
  • Speak English

Exclusion Criteria including the following:

  • Male
  • Not a current smoker
  • Do not use an Android cell phone
  • Do not have a valid email address
  • Do not have a valid phone number
  • Do not speak English

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: See Me Smoke-Free
Participants received access to the See Me Smoke-Free mobile application (app) delivered via smart phone, and were asked to use the app "most days" for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.
See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.
See Me Smoke-Free mHealth app delivered via a smart phone

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants Reporting Smoking Abstinence
기간: 3 months
Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.
3 months

2차 결과 측정

결과 측정
측정값 설명
기간
Weekly Minutes of Exercise
기간: 3 months
Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.
3 months
Servings of Fruit Per Day
기간: 3 months
Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.
3 months
Minutes of Guided Imagery Use Per Day
기간: Collected throughout each day for up to 90 days
Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.
Collected throughout each day for up to 90 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 1월 1일

기본 완료 (실제)

2015년 12월 1일

연구 완료 (실제)

2016년 12월 30일

연구 등록 날짜

최초 제출

2016년 11월 16일

QC 기준을 충족하는 최초 제출

2016년 11월 21일

처음 게시됨 (추정)

2016년 11월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 12월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 11월 27일

마지막으로 확인됨

2016년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 1R21CA174639 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

3
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