Clinical trial NCT06209996: A Weight Management Intervention for Overweight Chinese Cancer Survivors
Official title: Lose Little, Live Longer: A Randomised Controlled Feasibility Trial on a Diet-plus-exercise Weight Management Intervention for Overweight Chinese Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Weight Loss
Overweight and Obesity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-01-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a 3-arm feasibility trial study with one intervention group, one active control group and one waitlist control group. Computer-generated block randomization sequences will be generated by a statistician who is blinded to the identity of participants prior to the start of the trial. A block randomisation structure with randomly permuted block sizes of 3 and 6 will be used to reduce selection bias and ensure close balance of the numbers in each arm. The serially labelled opaque sealed envelope method will be used for randomisation.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of subject recruitment
timeFrame: baseline
measure: Rate of subject retention
timeFrame: baseline, 3-months and 6- months post-intervention
measure: Adherence rate to intervention
timeFrame: immediate post-intervention
measure: Rate of missing data
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: Change of weight
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: Change of BMI
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: change of Self efficacy
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
Secondary outcomes:
measure: Change of dietary assessment
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: change of skin carotenoid status
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: Change of physical activity level
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: change of health-related quality of life
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: change of Cancer-specific quality of life
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
measure: change of physical and psychological symptom distress
timeFrame: baseline, immediate post-intervention, 3-months and 6- months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong Jockey Club Institute of Cancer Care
Study officials:
affiliation: School of Public Health, The University of Hong Kong
name: Danielle Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: