- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06209996
A Weight Management Intervention for Overweight Chinese Cancer Survivors
February 28, 2024 updated by: The University of Hong Kong
Lose Little, Live Longer: A Randomised Controlled Feasibility Trial on a Diet-plus-exercise 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Danielle Ng, PhD
- Phone Number: +852 39179897
- Email: dwlng@hku.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 Comparator: 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.
|
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.
|
No Intervention: Waitlist
Participants allocated to the waitlist control arm will receive a set of pamphlets with generic, knowledge-based dietary and physical activity information.
All pamphlets are developed based on the self-management framework.
Participants in this arm will be arranged to attend to the L4 intervention upon completion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of subject recruitment
Time Frame: baseline
|
number of participants consent and being randomized/number of eligible patients x 100
|
baseline
|
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
|
baseline, 3-months and 6- months post-intervention
|
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
|
immediate post-intervention
|
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
|
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
|
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.
|
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
|
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.
|
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
|
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)
|
baseline, immediate post-intervention, 3-months and 6- months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
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.
|
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
|
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"
|
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
|
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.
|
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
|
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.
|
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
|
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).
|
baseline, immediate post-intervention, 3-months and 6- months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Danielle Ng, PhD, School of Public Health, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
December 12, 2023
First Submitted That Met QC Criteria
January 12, 2024
First Posted (Actual)
January 18, 2024
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW23-563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that underlie results in a publication will be available from the PI upon reasonable request.
IPD Sharing Time Frame
Starting 6 months after publication
IPD Sharing Access Criteria
Information will be available from the PI upon reasonable request.
The author to review requests is the PI.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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