- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04922164
Using Cueing Interventions to Promote Breastfeeding
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- University of Hong Kong School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Receive education-based messages about the health benefit of breastfeeding
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Other: Social normative cues
Receive social normative cues related to breastfeeding
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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. |
|
Other: Goal-related cues
Receive goal-related cues related to breastfeeding
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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The name of measurement: exclusive and any breastfeeding duration at one month postpartum Unit of measurement: the duration of breastfeeding |
Immediately after participants complete the questionnaire
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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
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The name of measurement: exclusive and any breastfeeding duration at three months postpartum Unit of measurement: the duration of breastfeeding |
Immediately after participants complete the questionnaire
|
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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 |
Immediately after participants complete the questionnaire
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20190320bf
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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