NCT06209996

A Weight Management Intervention for Overweight Chinese Cancer Survivors

Lose Little, Live Longer: A Randomised Controlled Feasibility Trial on a Diet-plus-exercise Weight Management Intervention for Overweight Chinese Cancer Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the weight management intervention on anthropometric measures (body weight and BMI), dietary quality, physical activity levels, physical and psychosocial functioning, self- efficacy for weight loss and quality of life.

Detailed description

The primary aim of the proposed study is to assess the feasibility and acceptability of conducting a randomized controlled trial (RCT) that evaluates an adaptive weight management intervention, tailored to Chinese cancer survivors with overweight/obesity after the completion of cancer survivorship care, to improve anthropometric measures (body weight and BMI), dietary quality, physical activity levels, physical and psychosocial functioning, self-efficacy for weight loss and quality of life. According to the Consolidation Standards of Reporting Trials (CONSORT) guidelines for reporting feasibility trials, hypothesis setting for a feasibility trial is not recommended, given that pilot trials are often underpowered to detect difference which instead should be the aim of the main trial.

Conditions

• Cancer
• Weight Loss
• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	L4 weight management intervention	he key goals of the intervention are to: (i) teach knowledge of weight loss benefits and health risks of obesity, (ii) offer skill-based dietary and physical activity advice, (iii) develop an achievable weight loss goal and plan, (iv) enhance weight management self-efficacy, (v) provide access to exercise equipment and resources, and (vi) teach strategies for managing cravings. The L4 intervention is a therapist- delivered intervention involving a registered dietitian and a cancer exercise specialist. Participants allocated to the intervention arm will be provided with a schedule to attend the L4 intervention within four weeks post-baseline via phone. They will receive five intervention sessions (120 min each) on a weekly basis, and will be given home-based practices and reading to practice the skills learnt in each session. The intervention sessions will be delivered in a group format with a maximum of 5 individuals per group, which is likely to enhance accountability.
BEHAVIORAL	Active control	A video-based intervention is selected as a low-touch alternative with expected benefits beyond a no treatment control. Participants allocated to the active control arm will receive five educational videos designed to promote a balanced diet and reinforce regular physical activity, weekly through instant messaging, and be encouraged to follow the advice covered in the videos. The materials will be developed based on the existing dietary and physical activity guidelines for cancer survivors. Participants in this arm will be arranged to attend to the L4 intervention upon completion of the study.

Timeline

• Start date: 2024-10-31
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-01-18
• Last updated: 2025-06-11

Locations

1 site across 1 country: Hong Kong