Behavior Change in Context to Contain the Spread of COVID-19

NCT04830761 | Completed DMC

• 1 other identifier: 2021-00164
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

Project BECCCS (=Behavior Change in Context to Contain the Spread of COVID-19) aims to optimise and test a behaviour change intervention to promote correct hand hygiene at key times in the short and long term. The study's specific aims are:

1. 1.Optimisation phase: Identify the most effective combination and sequence of three different intervention modules (habit, motivation, social norms), and to assess usability and fidelity measures in order to optimise the intervention
2. 2.Evaluation phase: Test the final intervention against an active control group (basic app content including "Federal Office of Public Health" advice)

Conditions

Hand Hygiene

Keywords

Behavioral intervention; Hand hygiene behavior; MOST; Health behavior change

Outcome Measures

Primary Outcomes (2)

• Average frequency of correct hand hygiene behaviour at key times

  First, participants indicate, whether they experienced key times, e.g. arriving home, after using the toilet, which require to wash or disinfect hands since the last questionnaire. Participants will then be asked how many times they correctly washed or disinfected hands at the indicated key times. The response options are 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Participants receive 5 questionnaires during a diary day. People attend a diary day after module 1 and after module 2. The frequencies across the 5-times daily diaries will be averaged to indicate the average frequency by which participants correctly performed hand hygiene at key times that day (scale ranging from 0 to 4).

  Day 16 (after module 1)

• Average frequency of correct hand hygiene behaviour at key times

  First, participants indicate, whether they experienced key times, e.g. arriving home, after using the toilet, which require to wash or disinfect hands since the last questionnaire. Participants will then be asked how many times they correctly washed or disinfected hands at the indicated key times. The response options are 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. Participants receive 5 questionnaires during a diary day. People attend a diary day after module 1 and after module 2. The frequencies across the 5-times daily diaries will be averaged to indicate the average frequency by which participants correctly performed hand hygiene at key times that day (scale ranging from 0 to 4).

  Day 33 (after module 2)

Secondary Outcomes (18)

• Frequency of hand hygiene behaviour at key times, but not correctly

  Day 16 (after module 1) and day 33 (after module 2)

• Self-reported behavioural intention

  Day 17 (main survey T2) and day 34 (main survey T3)

• Mean score of self-reported fife risk perception items

  Day 17 (main survey T2) and day 34 (main survey T3)

• Mean score of eight self-reported outcome-expectancies items

  Day 17 (main survey T2) and day 34 (main survey T3)

• Mean score of four self-reported coping planning items

  Day 17 (main survey T2) and day 34 (main survey T3)

Study Arms (9)

Habit - Motivation group

EXPERIMENTAL

First: 2 weeks habit intervention; Second: 2 weeks motivation intervention

Behavioral: Motivation; Behavioral: Habit

Habit - Social group

EXPERIMENTAL

First: 2 weeks habit intervention; Second: 2 weeks social intervention

Behavioral: Habit; Behavioral: Social

Habit - Habit group

EXPERIMENTAL

4 weeks habit intervention

Behavioral: Habit

Motivation - Habit group

EXPERIMENTAL

First: 2 weeks motivation intervention; Second: 2 weeks habit intervention

Behavioral: Motivation; Behavioral: Habit

Motivation - Social group

EXPERIMENTAL

First: 2 weeks motivation intervention; Second: 2 weeks social intervention

Behavioral: Motivation; Behavioral: Social

Motivation - Motivation group

EXPERIMENTAL

4 weeks motivation intervention

Behavioral: Motivation

Social - Habit group

EXPERIMENTAL

First: 2 weeks social intervention; Second: 2 weeks habit intervention

Behavioral: Habit; Behavioral: Social

Social - Motivation group

EXPERIMENTAL

First: 2 weeks social intervention; Second: 2 weeks motivation intervention

Behavioral: Motivation; Behavioral: Social

Social - Social group

EXPERIMENTAL

4 weeks social intervention

Behavioral: Social

Interventions

Motivation BEHAVIORAL

The key constructs targeted by the motivational module are attitudes towards the target behavior, risk perception, outcome expectancies and self-efficacy. The intervention includes the following techniques: information about health consequences, salience of consequences, goal setting (behavior), problem solving, verbal persuasion about capabilities, focus on past success (Michie et al., 2013)

Habit - Motivation group; Motivation - Habit group; Motivation - Motivation group; Motivation - Social group; Social - Motivation group

Habit BEHAVIORAL

The goal of the habit module is to guide participants to perform correct hand hygiene at self-selected key times repeatedly. The aim is that the behavior will be translated into a habit. The intervention includes the following techniques: Information about antecedents, self-monitoring of behavior, action planning, prompts/cues, habit formation, behavioral practice/ rehearsal, prompts/cues (physical cue) (Michie et al., 2013).

Habit - Habit group; Habit - Motivation group; Habit - Social group; Motivation - Habit group; Social - Habit group

Social BEHAVIORAL

The key constructs targeted by the social module are perceived norms including descriptive norms and injunctive norm. The intervention includes the following techniques: Monitoring of behavior by others, social incentive, social comparison, social reward, restructuring the physical environment, information about others approval, credible source, information about health consequences, feedback on behavior (Michie et al., 2013).

Habit - Social group; Motivation - Social group; Social - Habit group; Social - Motivation group; Social - Social group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years old
• Have signed an electronically written informed consent (online) form to participate in the study
• Own a smartphone with mobile access to the internet
• Be proficient in the German language to the degree that they understand the contents and instructions of the study.

Sponsors & Collaborators

• University of Bern: lead
• Ursula Wirz Stiftung: collaborator

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

Related Publications (16)

• Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, Eccles MP, Cane J, Wood CE. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013 Aug;46(1):81-95. doi: 10.1007/s12160-013-9486-6.

  PMID: 23512568 BACKGROUND

• Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.

  PMID: 17466815 BACKGROUND

• Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.

  PMID: 27049339 BACKGROUND

• Allan JL, Sniehotta FF, Johnston M. The best laid plans: planning skill determines the effectiveness of action plans and implementation intentions. Ann Behav Med. 2013 Aug;46(1):114-20. doi: 10.1007/s12160-013-9483-9.

  PMID: 23456214 BACKGROUND

• Bierbauer W, Inauen J, Schaefer S, Kleemeyer MM, Luscher J, Konig C, Tobias R, Kliegel M, Ihle A, Zimmerli L, Holzer BM, Siebenhuener K, Battegay E, Schmied C, Scholz U. Health Behavior Change in Older Adults: Testing the Health Action Process Approach at the Inter- and Intraindividual Level. Appl Psychol Health Well Being. 2017 Nov;9(3):324-348. doi: 10.1111/aphw.12094. Epub 2017 Oct 12.

  PMID: 29024515 BACKGROUND

• Orbell S, Verplanken B. The automatic component of habit in health behavior: habit as cue-contingent automaticity. Health Psychol. 2010 Jul;29(4):374-83. doi: 10.1037/a0019596.

  PMID: 20658824 BACKGROUND

• Ajzen I. The theory of planned behaviour: reactions and reflections. Psychol Health. 2011 Sep;26(9):1113-27. doi: 10.1080/08870446.2011.613995.

  PMID: 21929476 BACKGROUND

• Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: A longitudinal intervention study in cardiac rehabilitation. Br J Health Psychol. 2006 Feb;11(Pt 1):23-37. doi: 10.1348/135910705X43804.

  PMID: 16480553 BACKGROUND

• Perski O, Blandford A, Garnett C, Crane D, West R, Michie S. A self-report measure of engagement with digital behavior change interventions (DBCIs): development and psychometric evaluation of the "DBCI Engagement Scale". Transl Behav Med. 2020 Feb 3;10(1):267-277. doi: 10.1093/tbm/ibz039.

  PMID: 30927357 BACKGROUND

• Schmidt J, Lamprecht F, Wittmann WW. [Satisfaction with inpatient management. Development of a questionnaire and initial validity studies]. Psychother Psychosom Med Psychol. 1989 Jul;39(7):248-55. German.

  PMID: 2762479 BACKGROUND

• Schwarzer R, Schuz B, Ziegelmann JP, Lippke S, Luszczynska A, Scholz U. Adoption and maintenance of four health behaviors: theory-guided longitudinal studies on dental flossing, seat belt use, dietary behavior, and physical activity. Ann Behav Med. 2007 Apr;33(2):156-66. doi: 10.1007/BF02879897.

  PMID: 17447868 BACKGROUND

• Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.

  BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Baretta D, Ruttimann CL, Amrein MA, Inauen J. Promoting Hand Hygiene During the COVID-19 Pandemic: Randomized Controlled Trial of the Optimized Soapp+ App. JMIR Mhealth Uhealth. 2025 Apr 24;13:e57191. doi: 10.2196/57191.

  PMID: 40273441 DERIVED

• Baretta D, Amrein MA, Bader C, Ruschetti GG, Ruttimann C, Del Rio Carral M, Fabian C, Inauen J. Promoting Hand Hygiene During the COVID-19 Pandemic: Parallel Randomized Trial for the Optimization of the Soapp App. JMIR Mhealth Uhealth. 2023 Feb 3;11:e43241. doi: 10.2196/43241.

  PMID: 36599056 DERIVED

• Amrein MA, Ruschetti GG, Baeder C, Bamert M, Inauen J. Mobile intervention to promote correct hand hygiene at key times to prevent COVID-19 in the Swiss adult general population: study protocol of a multiphase optimisation strategy. BMJ Open. 2022 Mar 28;12(3):e055971. doi: 10.1136/bmjopen-2021-055971.

  PMID: 35351716 DERIVED

MeSH Terms

Interventions

Information Motivation Behavioral Skills Model; Sleep

Intervention Hierarchy (Ancestors)

Models, Psychological; Models, Theoretical; Investigative Techniques; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dario Baretta, Dr.

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, the MOST methodology (multiphase optimization strategy; Collins et al., 2007) will be applied. First, the most effective intervention components for specific target groups will be determined, which is called the optimisation phase. To this end, the investigators run a parallel randomized trial with nine intervention groups that investigates three interventions modules in different order. After this optimisation phase, the final intervention will be tested against an active control group (basic app content) in a randomized controlled trial, which is called the evaluation phase.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 5, 2021
• Study Start: March 26, 2021
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)