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临床试验/NCT05400187
NCT05400187已完成不适用

The Effectiveness on Healthy Eating and Weight Management by Body Composition Assessment and Smart-phone Based Counselling Among Middle-aged Hong Kong Chinese: A 6-month Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 221 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
221
试验地点
1
主要终点
The difference of the weight management knowledge

研究概览

简要总结

This study proposed an integrated multi-disciplinary approach including a professional and convenient body composition measurement and an immediate counselling after the measurement, followed by 6-month smart-phone based individualized counselling. We believe that this approach will promote healthy eating behaviors and weight management among middle-aged Chinese in Hong Kong.

详细描述

This is a two-arm, individual level, 6-month randomized controlled trial. The intervention group will receive convenient body composition measurement and 6-month smart-phone based individualized counselling. No specific intervention will be given to the control group except the common anthropometric and body composition measurement. A pretest-posttest evaluation and between-group comparison will be used to test whether the impact/success of the project has been achieved.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

During the randomization session, the generated random numbers will be placed in opaque and tamperproof envelopes and sealed. Another independent person (other than statistician) will open all envelopes for eligible participants and responsible for arranging participants to undertake their corresponding treatments. Participants, investigators, and statistician will be concealed about the random allocation until each participant has been registered and the assignments have been made. The research assistant who will perform the outcome measures and the statistician are blinded to treatment group assignment.

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to understand Cantonese and read Chinese;
  • Self-reported vegetable and fruit consumption is less than 5 servings per day (one serving means 125 mL (½ cup) fresh, frozen or canned fruits or vegetables; or 250 mL (1 cup) raw leafy veggies or salad; or 125 mL (½ cup) 100% juice; or 1 fruit;
  • Reachable by smart-phone and familiar with the use of smart-phone;
  • Would not move from the local area during the study period.

排除标准

  • Self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, osteoarthritis, and eating disorder;
  • Receiving medically prescribed diet or physical activity intervention;
  • For women, currently pregnant;
  • Have been taking any medications or long-term supplement such as herbs;
  • Cannot provide written informed consent.

结局指标

主要结局

The difference of the weight management knowledge

时间窗: From baseline to 6 months after randomization

The knowledge of weight management was measured by 13 items from the general nutrition knowledge questionnaire (GNKQ). Each item carries one point for a correct answer and the maximum score is 13. A higher score shows better weight management knowledge.

The difference of the weight management belief

时间窗: From baseline to 6 months after randomization

Four items from belief domain of Chinese weight management scales (WMS) was used to measure the participants' belief of self weight management . Each item is measured by 3- or 4-point Likert scale. The total score change from 4 to 15 with higher scores indicating better weight management belief.

次要结局

  • Weight(From baseline to 6 months after randomization)
  • Body mass index (BMI)(From baseline to 6 months after randomization)
  • Waist circumference(From baseline to 6 months after randomization)
  • Thigh circumference(From baseline to 6 months after randomization)
  • The difference of health eating behavior(From baseline to 6 months after randomization)
  • Systolic blood pressure(From baseline to 6 months after randomization)
  • Diastolic blood pressure(From baseline to 6 months after randomization)
  • Body fat mass(From baseline to 6 months after randomization)
  • Hip circumference(From baseline to 6 months after randomization)
  • Body fat percentage(From baseline to 6 months after randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

XIE Yao Jie Grace

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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