NCT04922164

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 26, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

June 4, 2021

Last Update Submit

January 1, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    Immediately after participants complete the questionnaire

Study Arms (3)

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

Behavioral: Cue intervention

Goal-related cues

OTHER

Receive goal-related cues related to breastfeeding

Behavioral: Cue intervention

Interventions

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.

Goal-related cuesSocial normative cues

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFirst-time mothers from the postnatal wards
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong School of Public Health

Hong Kong, China

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

July 26, 2021

Primary Completion

February 6, 2023

Study Completion

February 6, 2023

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations