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NCT Number: NCT06209996

A Weight Management Intervention for Overweight Chinese Cancer Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong Jockey Club Institute of Cancer Care

Hong Kong

Location status: Recruiting

Location contact

Wendy Lam

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese cancer survivors attending the one-off face-to-face survivorship care clinic
  • who are Cantonese- or Mandarin- speaking
  • aged 18 or above
  • diagnosed with early-stage disease (stage 0-II)
  • have completed primary and adjuvant treatments such as chemotherapy and radiotherapy
  • and with a BMI ≥ 23 kg/m2, as indicative as overweight or obesity using Asia-Pacific BMI cutoffs at 3-months reassessment

Exclusion criteria

  • Non-Chinese survivors with advanced or metastatic disease
  • who have communication difficulties, mobility impairment or cognitive disabilities

Treatment and study plan

L4 weight management intervention

Behavioral

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.

Active Control

Behavioral

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.

Primary outcomes

  1. Rate of subject recruitment

    Time frame: baseline

    number of participants consent and being randomized/number of eligible patients x 100

  2. Rate of subject retention

    Time frame: baseline, 3-months and 6- months post-intervention

    number of participants who complete follow-up assessments at 3 and 6 months post-baseline/number of participants enrolled x 100

  3. Adherence rate to intervention

    Time frame: immediate post-intervention

    number of participants who complete the intervention/number of being allocated to attend the intervention x 100

  4. Rate of missing data

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    number of participants with completed datasets for outcome measures/number of participant enrolled x 100

  5. Change of weight

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Weight will be assessed in light clothing and without shoes using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). To minimise measurement error, weight will be measured twice with accepted values within 0.1kg. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.

  6. Change of BMI

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    BMI will be assessed in light clothing and without shoes using a high-quality segmental body composition monitor (Tanita InnerScan BC545N). For the calculation of BMI (kg/m2), height will be measured to 0.01cm using a portable calibrated stadiometer (SECA Stadiometer). To minimise measurement error, weight and height will be measured twice with accepted values within 0.1kg and 0.3cm, respectively. If either measure falls outside the accepted range, a third measure will be taken. The average of the two acceptable measures will be used in the analysis.

  7. change of Self efficacy

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Self-efficacy for weight loss will be assessed using the 11-item Physical Activity and Nutrition Self-Efficacy (PANSE) scale. Each item is rated on a 9-point Likert scale ranging from 1 "not at all confident" to 9 "highly confident". Total score range is 11 to 99, with higher scores indicative as greater perceived self-efficacy for weight loss. The PANSE has demonstrated strong internal consistency (Cronbach α = .89), convergent validity, and test-retest reliability.(18)

Secondary outcomes

  1. Change of dietary assessment

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Dietary quality will be assessed with a three-day dietary record. Participants will be instructed to record their diet for three consecutive days including two weekdays and one weekend day, and not to alter their diet deliberately. All dietary records will be coded for the following food groups: (1) total grains, (2) refined grains, (3) whole grains, (4) fruits, (5) vegetables, (6) pork, (7) beef and other red meats, and (8) processed meats.

  2. change of skin carotenoid status

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Skin carotenoid status, a biomarker of fruit and vegetable intake, will be measured by the Veggie Meter. The Veggie Meter is a non-invasive tool that utilizes the optical method of reflective spectroscopy upon pressure of the fingertip on the lens to measure skin carotenoid status. Three consecutive measurements will be taken per participant without removing the finger from the lens, and the average of the three ranging from 0-800 will be used with higher scores indicating higher fruit and vegetable intake.

  3. Change of physical activity level

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Physical activity level will be assessed using the Global Physical Activity Questionnaire (GPAQ) developed by World Health Organization. The GPAQ measures how many days per week (0-7 days) and how many times in minutes per day (0-1440 minutes) spent doing different types of physical activity.

  4. change of health-related quality of life

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    The generic EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire evaluates five dimensions including mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale (1 = no problem; 2 = slight problem; 3 = moderate problem; 4 = severe problem; 5 = extreme problem).

  5. change of Cancer-specific quality of life

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Cancer-specific quality of life will be assessed using the standard Chinese version of the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30), which measures five function domains (physical, role, emotional, cognitive and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health QoL subscale, five single symptoms items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial difficulties, using a 4-point Likert scale ranging from 0 "Not at all" to 3 "Very much"

  6. change of physical and psychological symptom distress

    Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention

    Physical and psychological symptom distress will be measured using the 10-item Edmonton Symptom Checklist (ESAS).The ESAS comprises 10 symptoms commonly observed in cancer patients (including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, and sleep difficulty) that assess three components: physical, emotional and total symptom burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Ng, PhD

CONTACT

[email protected]

+852 39179897

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 18, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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