A Self-efficacy Based Dietary Intervention

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04961827
• Other study ID #: UW20-622
• Status: Terminated
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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have often been used to facilitate improvements of dietary quality beyond nutrition counseling sessions but are outdated.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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Self-efficacy based images through instant messaging
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.
• Knowledge based images through instant messaging
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.

Locations

Country	Name	City	State
Hong Kong	JCICC	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline in mean self-efficacy score	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
Primary	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
Primary	Changes from baseline in mean skin carotenoid reading	Skin carotenoid status reading measured by a reflective spectroscopy machine	Baseline and 3 months