A Self-efficacy Based Dietary Intervention

May 7, 2024 updated by: Wendy Wing Tak Lam, The University of Hong Kong

Eat Well After Cancer: a Randomized Controlled Trial of a Self-efficacy Based Dietary Intervention Among Chinese Cancer Survivors

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

Study Overview

Detailed Description

Healthy eating is linked to improved survival and quality of life among cancer survivors. However, previous studies showed that most cancer survivors were not adhering to dietary recommendations despite having made changes post-diagnosis.

Conventional nutrition counseling interventions are often used in this population. However, they are labor and cost intensive and involved multiple sessions with participants. Written materials have often been used to facilitate improvements of dietary quality beyond nutrition counseling sessions but are outdated. Therefore, we propose to develop and test the effectiveness of a dietary intervention aiming to enhance self-efficacy through sending images through instant messaging. Methods to increase self-efficacy include performance accomplishment, persuasion, modelling and peer-modelling.

A prospective, randomized controlled trial design will be used to test the effectiveness of the intervention. A total of 168 adult Chinese cancer survivors, diagnosed with non-metastatic cancer (Stages 0-III), and have completed all active treatments, including surgery and adjuvant treatments such as chemotherapy and radiation therapy will be recruited.

Participants will be randomly assigned into one of two groups at a 1:1 ratio, using computer-generated block randomization sequences. The first group will be an active control group. Participants in this group will receive knowledge-based dietary information through an instant messaging applications biweekly for 6 times. The second group will be the intervention group. Participants will receive biweekly self-efficacy enhancing materials for 6 times. Materials will provide information about behavior-health link, provide information on consequences, provide instruction, and provide opportunities for social comparison. For example, the materials will provide recipe ideas and meal planning samples from fellow cancer survivors. All materials will be developed by a registered dietitian and will be consistent with published dietary guidelines for cancer survivors.

Participants will have follow-up appointments at 3 months. Their dietary quality and skin carotenoid status will be monitored. It is hypothesized that dietary quality will be better and skin carotenoid status will be higher for participants in the intervention group compared to participants in the active control group.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: Self-efficacy based images
Intervention group with self-efficacy based images sent through instant messaging biweekly for 6 times.
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.
Active Comparator: Active control: knowledge based images
Active control group with knowledge based images sent through instant messaging biweekly for 6 times.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in mean dietary quality
Time Frame: Baseline and 3 months
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
Time Frame: Baseline and 3 months
Skin carotenoid status reading measured by a reflective spectroscopy machine
Baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in mean self-efficacy score
Time Frame: Baseline and 3 months
Dietary related self-efficacy measured by a 15-item scale (DIET-SE), consisted of 10 scenario based questions and 5 general questions.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wendy Lam, School of Public Health, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UW20-622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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