A Weight Management Intervention for Overweight Chinese Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L4 weight management intervention, Active control.
- Who it may be relevant to
- Registry conditions: Cancer, Weight Loss, Overweight and Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lose Little, Live Longer: A Randomised Controlled Feasibility Trial on a Diet-plus-exercise Weight Management Intervention for Overweight Chinese Cancer Survivors
Overview
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.
Interventions
- 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 speci - 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. Part
Primary outcome measures
- Rate of subject recruitment [Time frame: baseline]
- Rate of subject retention [Time frame: baseline, 3-months and 6- months post-intervention]
- Adherence rate to intervention [Time frame: immediate post-intervention]
- Rate of missing data [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- Change of weight [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- Change of BMI [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- change of Self efficacy [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
Secondary outcome measures (6)
- Change of dietary assessment [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- change of skin carotenoid status [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- Change of physical activity level [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- change of health-related quality of life [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- change of Cancer-specific quality of life [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
- change of physical and psychological symptom distress [Time frame: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The University of Hong Kong Jockey Club Institute of Cancer Care — Hong Kong
Identifiers
NCT: NCT06209996 · UW23-563