Breast FeedingNCT04922164
Using Cueing Interventions to Promote Breastfeeding
A study testing Cue intervention in people with Breast Feeding, run by The University of Hong Kong at 1 site in China.
Trial summary
Background: Interventions focusing on promoting good behavioural intentions were found to only have small-to-moderate effect sizes on changing the actual behaviours. Self-regulation plays an important role to maintain individual attentions to the distant benefits of healthy behaviours and resist to proximal tempting… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Cue intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to 6 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being ≥18 years
- being Chinese ethnicity and Hong Kong residents
- without any serious medical or obstetric complications
- having a full-term (i.e. gestational age ≥37 weeks) healthy infant with normal birthweight (≥2,500 grams)
Who cannot join
- with linguistic and cognitive barriers impeding completion of face-to-face and telephone interviews or comprehension of the intervention materials
- physical anomalies that contraindicate breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Cueing Interventions to Bridge Intention-behaviour Gaps: an Longitudinal Experimental Study on Promoting Breastfeeding
Background: Interventions focusing on promoting good behavioural intentions were found to only have small-to-moderate effect sizes on changing the actual behaviours. Self-regulation plays an important role to maintain individual attentions to the distant benefits of healthy behaviours and resist to proximal tempting cues from unhealthy behaviours, and thereby facilitate the translation of good intention into actual behaviours. However, self-regulation resources are limited and can be depleted in certain contexts. Providing environmental cues relevant to the desirable behaviours can activate the nonconscious process and lead to behavioural change without conscious awareness, the underlying mechanism of cueing interventions.
Aims: To test the effectiveness of using two types of cues, social normative and goal-related cues, to activate the nonconscious process for facilitating the translation of intentions into actual behaviours. We hypothesize that (1) cueing interventions will be more effective than will conventional education-based interventions (providing factual information about health benefits) be for changing behaviours; (2) cueing interventions are more effective for participants who have a tendency to use an intuitive mode in information processing; and (3) goal priming is more effective for participants with stronger motivation to pursue the goal of sustaining breastfeeding.
Subject and study design: The hypotheses will be tested in the behavioural context of breastfeeding among first-time mothers because: first, primiparous women may have less self-regulation resources due to high cognitive demand for postpartum adjustment during motherhood transition; and second, while breastfeeding intention and initiation were high, maintaining breastfeeding for the first six months postpartum was generally low in Hong Kong, indicating a substantial intention-behaviour gap. We propose to recruit 600 primiparous women. Baseline assessments will be conducted face-to-face using a standardized questionnaire. Participants will be randomly allocated to the control group (receive education-based messages about the health benefit of breastfeeding) or one of the two intervention groups (receive either social normative cues or goal-related cues related to breastfeeding). All messages will be delivered through smartphone on a daily basis over 16 weeks postpartum.
- Conditions
- Breast Feeding
- Being tested
- Cue intervention
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue interventionBehavioural
Around 30 pieces of narrative information about how a mother behaves in specific decision context will be derived from our qualitative study to construct social normative cues.
For goal-related cues, words relating to each category of breastfeeding-related values, benefits and goals will be identified and used to construct the messages (e.g. "attractive body shape", "smart baby", "natural", "strong immunity" and etc.). Each goal-priming message will be presented with brief priming words and a picture of an image of the desirable goal.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Receive education-based messages about the health benefit of breastfeeding |
| Social normative cues | Other | Receive social normative cues related to breastfeeding Receives: Behavioral: Cue intervention |
| Goal-related cues | Other | Receive goal-related cues related to breastfeeding Receives: Behavioral: Cue intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of two cueing interventions, cueing with social norms and goal priming at one month postpartum
The name of measurement: exclusive and any breastfeeding duration at one month postpartum
Unit of measurement: the duration of breastfeeding
Measured: Immediately after participants complete the questionnaire
The effectiveness of two cueing interventions, cueing with social norms and goal priming at three months postpartum
The name of measurement: exclusive and any breastfeeding duration at three months postpartum
Unit of measurement: the duration of breastfeeding
Measured: Immediately after participants complete the questionnaire
The effectiveness of two cueing interventions, cueing with social norms and goal priming at six months postpartum
The name of measurement: exclusive and any breastfeeding duration at six months postpartum
Unit of measurement: the duration of breastfeeding
Measured: Immediately after participants complete the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start26 Jul 2021
- Primary completion6 Feb 2023
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiuyan Liao, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922164
- Sponsor's protocol ID
- 20190320bf
- Status last verified
- Jan 2024
- First submitted
- 4 Jun 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cueing Interventions to Bridge Intention-behaviour Gaps: an Longitudinal Experimental Study on Promoting Breastfeeding
- ClinicalTrials.gov ID
- NCT04922164
- Acronym / sponsor ID
- 20190320bf
- Conditions
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Interventions focusing on promoting good behavioural intentions were found to only have small-to-moderate effect sizes on changing the actual behaviours. Self-regulation plays an important role to maintain individual attentions to the distant benefits of healthy behaviours and resist to proximal tempting cues from unhealthy behaviours, and thereby facilitate the translation of good intention into actual behaviours. However, self-regulation resources are limited and can be depleted in certain contexts. Providing environmental cues relevant to the desirable behaviours can activate the nonconscious process and lead to behavioural change without conscious awareness, the underlying mechanism of cueing interventions.
Aims: To test the effectiveness of using two types of cues, social normative and goal-related cues, to activate the nonconscious process for facilitating the translation of intentions into actual behaviours. We hypothesize that (1) cueing interventions will be more effective than will conventional education-based interventions (providing factual information about health benefits) be for changing behaviours; (2) cueing interventions are more effective for participants who have a tendency to use an intuitive mode in information processing; and (3) goal priming is more effective for participants with stronger motivation to pursue the goal of sustaining breastfeeding.
Subject and study design: The hypotheses will be tested in the behavioural context of breastfeeding among first-time mothers because: first, primiparous women may have less self-regulation resources due to high cognitive demand for postpartum adjustment during motherhood transition; and second, while breastfeeding intention and initiation were high, maintaining breastfeeding for the first six months postpartum was generally low in Hong Kong, indicating a substantial intention-behaviour gap. We propose to recruit 600 primiparous women. Baseline assessments will be conducted face-to-face using a standardized questionnaire. Participants will be randomly allocated to the control group (receive education-based messages about the health benefit of breastfeeding) or one of the two intervention groups (receive either social normative cues or goal-related cues related to breastfeeding). All messages will be delivered through smartphone on a daily basis over 16 weeks postpartum.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Receive education-based messages about the health benefit of breastfeeding |
| Social normative cues | Other | Behavioral: Cue interventionReceive social normative cues related to breastfeeding |
| Goal-related cues | Other | Behavioral: Cue interventionReceive goal-related cues related to breastfeeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being ≥18 years
- being Chinese ethnicity and Hong Kong residents
- without any serious medical or obstetric complications
- having a full-term (i.e. gestational age ≥37 weeks) healthy infant with normal birthweight (≥2,500 grams)
Key exclusion criteria (2 listed)
- with linguistic and cognitive barriers impeding completion of face-to-face and telephone interviews or comprehension of the intervention materials
- physical anomalies that contraindicate breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue interventionAround 30 pieces of narrative information about how a mother behaves in specific decision context will be derived from our qualitative study to construct social normative cues. For goal-related cues, words relating to each category of breastfeeding-related values, benefits and goals will be identified and used to construct the messages (e.g. "attractive body shape", "smart baby", "natural", "strong immunity" and etc.). Each goal-priming message will be presented with brief priming words and a picture of an image of the desirable goal. | Behavioural | Goal-related cues, Social normative cues |
Primary outcome
The effectiveness of two cueing interventions, cueing with social norms and goal priming at one month postpartum
Time frame: Immediately after participants complete the questionnaire
The name of measurement: exclusive and any breastfeeding duration at one month postpartum Unit of measurement: the duration of breastfeeding
The effectiveness of two cueing interventions, cueing with social norms and goal priming at three months postpartum
Time frame: Immediately after participants complete the questionnaire
The name of measurement: exclusive and any breastfeeding duration at three months postpartum Unit of measurement: the duration of breastfeeding
The effectiveness of two cueing interventions, cueing with social norms and goal priming at six months postpartum
Time frame: Immediately after participants complete the questionnaire
The name of measurement: exclusive and any breastfeeding duration at six months postpartum Unit of measurement: the duration of breastfeeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue intervention in people with Breast Feeding, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of two cueing interventions, cueing with social norms and goal priming at one month postpartum (time frame: Immediately after participants complete the questionnaire). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.