A Weight Management Intervention for Overweight Chinese Cancer Survivors

NCT06209996 | Recruiting

• 1 other identifier: UW23-563
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Weight Loss; Overweight and Obesity

Outcome Measures

Primary Outcomes (7)

• Rate of subject recruitment

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

  baseline

• Rate of subject retention

  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

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

  immediate post-intervention

• Rate of missing data

  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

  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

  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

  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 Outcomes (6)

• Change of dietary assessment

  baseline, immediate post-intervention, 3-months and 6- months post-intervention

• change of skin carotenoid status

  baseline, immediate post-intervention, 3-months and 6- months post-intervention

• Change of physical activity level

  baseline, immediate post-intervention, 3-months and 6- months post-intervention

• change of health-related quality of life

  baseline, immediate post-intervention, 3-months and 6- months post-intervention

• change of Cancer-specific quality of life

  baseline, immediate post-intervention, 3-months and 6- months post-intervention

Study Arms (3)

L4 weight management intervention

EXPERIMENTAL

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.

Behavioral: L4 weight management intervention

Active control

ACTIVE COMPARATOR

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.

Behavioral: Active control

Waitlist

NO INTERVENTION

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.

Interventions

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.

L4 weight management intervention

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.

Active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

The University of Hong Kong Jockey Club Institute of Cancer Care

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Neoplasms; Weight Loss; Overweight; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Danielle Ng, PhD

  School of Public Health, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Ng, PhD

CONTACT

+852 39179897; dwlng@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, care provider, and outcomes assessor are masked in terms of not knowing to which condition the participants will be randomized until after the completion of the baseline assessment. The outcomes assessor will break the envelope for the next eligible participant indicating if that participant is to be allocated to intervention or active control or waitlist arms. The participants are masked in terms of not knowing that the intervention are hypothesized to yield larger effects than the others (i.e. controls).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 18, 2024
• Study Start: October 31, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication
• Access Criteria: Information will be available from the PI upon reasonable request. The author to review requests is the PI.

Locations

HK (1)