A Weight Management Intervention for Overweight Chinese Cancer Survivors

The University of Hong Kong (HKU)

Status: Begins enrollment this month

Conditions: Weight Loss; Overweight and Obesity; Cancer

Treatments: Behavioral: L4 weight management intervention; Behavioral: Active control

Study type: Interventional

Funder types: Other

Identifiers

NCT06209996

UW23-563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 3 patient groups

L4 weight management intervention

Experimental group

Description:

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.

Treatment:

Behavioral: L4 weight management intervention

Active control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active control

Waitlist

No Intervention group

Description:

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.