A Weight Management Intervention for Overweight Chinese Cancer Survivors
- Conditions
- Weight LossCancerOverweight and Obesity
- Interventions
- Behavioral: L4 weight management interventionBehavioral: Active control
- Registration Number
- NCT06209996
- Lead Sponsor
- The University of Hong Kong
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 102
- 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
- Non-Chinese survivors with advanced or metastatic disease
- who have communication difficulties, mobility impairment or cognitive disabilities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L4 weight management intervention L4 weight management intervention A weight management intervention, namely Lose Little, Live Longer (L4), is recently developed to assist overweight cancer survivors in weight loss through lifestyle modification including improved dietary quality and enhanced physical activity levels. Its underlying theoretical framework is principally derived from Social Cognitive Theory (SCT), which have been widely used in health behavioural change interventions. Active control 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.
- Primary Outcome Measures
Name Time Method Rate of subject recruitment baseline number of participants consent and being randomized/number of eligible patients x 100
Change of weight 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.
Change of BMI 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.
Rate of missing data 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
Rate of subject retention 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
Adherence rate to intervention immediate post-intervention number of participants who complete the intervention/number of being allocated to attend the intervention x 100
change of Self efficacy 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 Outcome Measures
Name Time Method change of health-related quality of life 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).
change of skin carotenoid status 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.
Change of dietary assessment 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.
Change of physical activity level 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.
change of Cancer-specific quality of life 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"
change of physical and psychological symptom distress 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.