NCT04961827

Brief Summary

To develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
terminated

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

July 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

July 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

July 9, 2021

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in mean dietary quality

    Servings of fruit and vegetables per day, number of red meat servings per week and ratio of whole to refined grains measured by a 3-day dietary record self-completed by participants before baseline and 3-months follow-up

    Baseline and 3 months

  • Changes from baseline in mean skin carotenoid reading

    Skin carotenoid status reading measured by a reflective spectroscopy machine

    Baseline and 3 months

Other Outcomes (1)

  • Changes from baseline in mean self-efficacy score

    Baseline and 3 months

Study Arms (2)

Intervention: Self-efficacy based images

EXPERIMENTAL

Intervention group with self-efficacy based images sent through instant messaging biweekly for 6 times.

Behavioral: Self-efficacy based images through instant messaging

Active control: knowledge based images

ACTIVE COMPARATOR

Active control group with knowledge based images sent through instant messaging biweekly for 6 times.

Behavioral: Knowledge based images through instant messaging

Interventions

A total of 6 images will be sent to participants via instant messaging. Images will utilize concepts in the Theory of self-efficacy to increase dietary self-efficacy among participants and hence improve dietary quality beyond that of conventional nutrition counseling.

Intervention: Self-efficacy based images

A total of 6 images will be sent to participants via instant messaging. Images will consist of information covered in nutrition counseling sessions, such as those related to serving sizes.

Active control: knowledge based images

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or above
  • Diagnosed with cancer, non-metastatic (Stages 0-III)
  • Ability to read Chinese and speak Cantonese or Putonghua/Mandarin
  • Completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy
  • Attending clinic with nutrition counseling at study site

You may not qualify if:

  • Ethnicity other than Chinese
  • Diagnosed with mental, hearing, speech, or cognitive disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JCICC

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Wendy Lam

    School of Public Health, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 14, 2021

Study Start

July 29, 2021

Primary Completion

December 22, 2022

Study Completion

December 22, 2022

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations