Impact of a smoking cessation program on smoking prevalence and food security among food pantry users – a study protocol for a cluster-randomized pragmatic controlled trial
Organizational Data
- DRKS-ID:
- DRKS00020037
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2020-04-29
- Last update in DRKS:
- 2021-09-28
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Many food pantry users are food insecure and smoke. Probably, smoking and food insecurity are are related to one another. A study will be conducted to evaluate the impact of a smoking cessation program adapted to food pantry users on the smoking status and on the food security level among food pantry users. In the first phase, a group discussion with food pantry users and telephone interviews with smoking cessation trainers, social workers and psychologists will be conducted. In the second phase, at least 32 food pantries (clusters) with 416 participating food pantry users in Berlin, Germany, shall be split into an intervention and a control group. The intervention will consist of the behavioural group program for smoking cessation previously adapted to food pantry users as well as optional nicotine replacement therapy and non-smoker friendly measures in the food pantries. The waiting list control group will receive the intervention around nine months after the intervention group. Participants will be asked to fulfil a questionnaire and to measure exhaled carbon monoxide three times.
Brief summary in scientific language
Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users. In the first phase, a mixed method approach will be used to develop the intervention. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes six months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level).
Health condition or problem studied
- ICD10:
- F17.2
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- The intervention will consist of the smoking cessation program previously designed for food pantry users as well as optional nicotine replacement therapy and the implementation of ecological non-smoker friendly measures in the food pantries.
- Arm 2:
- The control group will be provided with the usual food pantry supply and will receive the intervention when the last data collection period will be finished (waiting list control group).
Endpoints
- Primary outcome:
- Primary outcomes are the continuous smoking abstinence and increased food security level (the percentage of participants with an improved food security level) six months after the treatment. Smoking cessation is defined as the self-reported continuous smoking cessation (≤ 5 cigarettes since the defined day of stopping smoking) validated by exhaled carbon monoxide (< 10 ppm). Food insecurity is categorized in food security, mild food insecurity, moderate food insecurity, and severely food insecurity according to the Food and Agriculture Organization of the United Nations.
- Secondary outcome:
- Secondary outcomes at one and/or six months post-intervention include the point prevalence abstinence, the mean number of smoked cigarettes per day, the mean number of affirmative responses at the FIES, and the health-related quality of life.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Tafel Ausgabestellen Berlin
Recruitment period and number of participants
- Planned study start date:
- 2021-10-15
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 416
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Users of any of the participating food pantries who reported to smoke at least one cigarette or cigarillo per day and are able to sufficiently understand and speak German.
Exclusion Criteria
Non-smokers and individuals smoking less than daily as well as individuals who do not use any of the participating food pantries; individuals who are 17 years of age or less, are unable to understand and speak German or are illiterate; individuals who only use e-cigarettes or tobacco heating systems
Addresses
Primary Sponsor
- Address:
- Fg. Angewandte Ernährungspsychologie, Universität HohenheimProf. Dr. Nanette Ströbele-BenschopFruwirthstraße 1270599 StuttgartGermany
- Telephone:
- +49 (0)711/ 459 24620
- Fax:
- +49 (0)711/ 459 24343
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://epsych.uni-hohenheim.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Fg. Angewandte Ernährungspsychologie, Universität HohenheimProf. Dr. Nanette Ströbele-BenschopFruwirthstraße 1270599 StuttgartGermany
- Telephone:
- +49 (0)711/ 459 24620
- Fax:
- +49 (0)711/ 459 24343
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://epsych.uni-hohenheim.de/
Contact for Public Queries
- Address:
- Fg. Angewandte Ernährungspsychologie, Universität HohenheimProf. Dr. Nanette Ströbele-BenschopFruwirthstraße 1270599 StuttgartGermany
- Telephone:
- +49 (0)711/ 459 24620
- Fax:
- +49 (0)711/ 459 24343
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://epsych.uni-hohenheim.de/
Principal Investigator
- Address:
- Fg. Angewandte Ernährungspsychologie, Universität HohenheimProf. Dr. Nanette Ströbele-BenschopFruwirthstraße 1270599 StuttgartGermany
- Telephone:
- +49 (0)711/ 459 24620
- Fax:
- +49 (0)711/ 459 24343
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://epsych.uni-hohenheim.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Verband der Ersatzkassen e.V. (vdek)Askanischer Platz 110963 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Private sponsorship (foundations, study societies, etc.)
- Address:
- Deutsche Krebshilfe gGmbHBuschstraße 3253113 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Universität HohenheimGarbenstr. 3070599 StuttgartGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-hohenheim.de/senat#jfmulticontent_c241393-4
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-01-25
- Ethics committee number:
- No Entry
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-02-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Due to the sensibility and intimacy of the data.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry