A Weight Management Intervention for Overweight Chinese Cancer Survivors

Официальное название

Lose Little, Live Longer: A Randomised Controlled Feasibility Trial on a Diet-plus-exercise Weight Management Intervention for Overweight Chinese Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Rate of subject recruitment [Срок оценки: baseline]
• Rate of subject retention [Срок оценки: baseline, 3-months and 6- months post-intervention]
• Adherence rate to intervention [Срок оценки: immediate post-intervention]
• Rate of missing data [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• Change of weight [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• Change of BMI [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• change of Self efficacy [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]

Вторичные конечные точки (6)

• Change of dietary assessment [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• change of skin carotenoid status [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• Change of physical activity level [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• change of health-related quality of life [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• change of Cancer-specific quality of life [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]
• change of physical and psychological symptom distress [Срок оценки: baseline, immediate post-intervention, 3-months and 6- months post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The University of Hong Kong Jockey Club Institute of Cancer Care — Гонконг

Идентификаторы

NCT: NCT06209996 · UW23-563

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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