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临床试验/NCT06360432
NCT06360432已完成不适用

Effects of the EatWelLog App on Enhancing Daily Diet Management for Community-dwelling Older Adults With Sarcopenic Obesity: A Pilot Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Changes of muscle strength

研究概览

简要总结

Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.

This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:

  • their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,
  • nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.

The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.

Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.

Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0.

详细描述

Sarcopenic obesity (SO), characterized by concurrent reduced muscle mass and excess body fat, affects 11% older adults worldwide, rising to 23% among those over 751. Older adults with reduced muscle mass are 1.95-2.62 times prone to obesity than those with normal muscle mass. This is due to shared etiological factors between sarcopenia and obesity such as sedentary habits and aging-related biological shifts, including decreased anabolic hormones, increased insulin resistance, and escalated oxidative stress. The combination of sarcopenia and obesity has a compounding negative impact on health, raising the likelihood of knee and hip osteoarthritis, which leads to reduced physical capabilities, as well as increasing the risk of cardio-metabolic diseases, institutionalized, and death, exceeding the risks of sarcopenia or obesity alone.

Addressing SO effectively to promote muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies. Currently, exercise and nutrition interventions, are the most commonly recommended interventions.

Exercise and Nutrition Interventions for SO A recent systematic review of 11 trials with 440 SO participants showed that resistance training twice weekly for 20 minutes over a minimum of 8 weeks effectively enhances body composition, muscle strength, and gait speed. Furthermore, evidence suggested that combining aerobic and resistance training with increased protein intake is more effective in reducing body fat than resistance training alone but had no effects on muscle mass and strength. Another systematic review of eight trials with 605 SO participants found that resistance training alone could increase muscle strength. To also improve physical functions (i.e., gait speed and grip strength), exercise combining aerobic and resistance training with dietary supplements seems to have more promising results. The findings in a recent umbrella review of meta-analyses concluded that exercise interventions (either resistance training or combined resistance and aerobic exercise) are beneficial for body composition and physical performance in older adults with SO. However, the added value of exercise with nutrition interventions (either protein supplement and dietary modifications) produces inconsistent results.

Adequate protein intake is vital for muscle building, and calorie restriction is effective at reducing fat mass. Thus, nutrition is a critical factor in the onset and progression of SO, although the evidence for nutrition interventions in reserving SO demonstrated inconsistent effects, especially regarding muscle mass and strength. When implementing a weight loss diet for individuals with SO, it is important to balance fat reduction with muscle mass preservation by ensure adequate protein intake to prevent exacerbating muscle loss. Evidence suggests that the source of protein is crucial for muscle retention, specifically for animal-based proteins, which are high in leucine, may be more effective in preserving muscle mass during weight loss and in maintaining physical function. While nutritional supplements are commonly used to increase protein intake, their effects on SO remain inconsistent and may cause side effects such as digestive issues, interact with certain medications, dehydration, liver and renal damage, bloating, and calcium loss. The investigators advocates for an unhealthy diet incorporating a full spectrum of nutrients from whole foods, in line with the Dietary Guidelines for Americans, 2020-2025, as the preferred approach over supplements for those with sarcopenic obesity. Modifying daily dietary habits of individuals with SO may provide more sustainable benefits than merely adding supplements to their diet.

A recent systematic review examining nutrition interventions in managing sarcopenic obesity analysed nine studies but only two assessed the impact of dietary modifications on protein intake among older adults with SO. The first randomized controlled trial (RCT) assessed the impact of a low-calorie diet with normal (0.8 g/kg body weight/day) versus high protein intake (1.2 g/kg body weight/day) over three months in 104 older women with SO. The study found muscle mass decreased in the normal protein group concurrent with fat loss, while the high protein group saw muscle mass preservation. The second pilot RCT involving 18 women compared a low-calorie diet with placebo to one with high protein (1.2-1.4 g/kg body weight/day) over four months. Significant muscle strength gains were noted in the high protein group, though changes in muscle mass were not significantly different between the two groups. While the findings in these two trials provided preliminary evidence that hypocaloric diet and high protein intake may be necessary for managing SO, particularly for preserving mass muscle and strength. These studies, however, had limitations such as broad inclusion criteria for sarcopenic obesity, lacking a standardized diagnostic protocol, insufficient data on dietary adherence, and opaque details regarding randomization and intervention specifics. More rigorous research is needed to investigate the impact of diet modification on sarcopenic obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

An independent assessor who is blinded to the group allocations will assess the participants' outcomes.

入排标准

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

入选标准

  • Aged 65 or above, and living in the community;
  • Having SO according to the Asian Working Group for Sarcopenia (AWGS) and the World Health Organization (WHO)'s obesity criteria for Asians:
  • Early-stage sarcopenia indicated by fulfilment of one of the following criteria; handgrip strength <28 kg (men) and <18 kg (women); appendicular skeletal muscle mass (ASM)/ height2 <7 kg/m2 (men) and <5.7 kg/m2 (women), or SPPB score of <9; Short Physical Performance Battery (SPPB) score of <9,
  • Obesity indicated by BMI ≥25 kg/m2, waist circumference ≥90 cm (men) and ≥80 cm (women), or body fat >30%;
  • Own a smartphone with internet access; and
  • Proficiency in communicating, reading, and writing in Chinese, and without major hearing and vision impairments to ensure that comprehension of our instructions.

排除标准

  • Individuals with diseases impacting digestion or food consumption, including severe cardiac/ pulmonary/ renal diseases, diabetes, cancer, or autoimmune disorders;
  • Those on medications affecting eating habits, digestion, or metabolism, such as weight loss drugs;
  • Persons with alcohol use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), potentially hindering dietary behaviour changes;
  • Those with medical implants like pacemakers that could be disrupted by the bioelectric impedance analysis (BIA's) low-level electrical currents.

研究组 & 干预措施

M-health group

Experimental

Participants in the M-health will receive an 8-week program consisting of personalized dietary modification program and group-based exercise training. Additionally, the m-health group will be instructed to use the EatWellLog app for daily diet self-management.

干预措施: Dietary modification program (Behavioral)

M-health group

Experimental

Participants in the M-health will receive an 8-week program consisting of personalized dietary modification program and group-based exercise training. Additionally, the m-health group will be instructed to use the EatWellLog app for daily diet self-management.

干预措施: Exercise training (Behavioral)

M-health group

Experimental

Participants in the M-health will receive an 8-week program consisting of personalized dietary modification program and group-based exercise training. Additionally, the m-health group will be instructed to use the EatWellLog app for daily diet self-management.

干预措施: The EatWellLog App (Behavioral)

Control group

Sham Comparator

Participants in the Control group will receive an identical, 8-week program consisting of personalized dietary modification program and group-based exercise training without using the EatWellLog App.

干预措施: Dietary modification program (Behavioral)

Control group

Sham Comparator

Participants in the Control group will receive an identical, 8-week program consisting of personalized dietary modification program and group-based exercise training without using the EatWellLog App.

干预措施: Exercise training (Behavioral)

结局指标

主要结局

Changes of muscle strength

时间窗: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program

Handgrip strength (kg) will be measured by using the hand dynamometer.

Changes of body mass index

时间窗: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program

The weight and height will be combined to report BMI in kg/m\^2.

The Short Physical Performance Battery (SPPB) scale

时间窗: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program

The Short Physical Performance Battery (SPPB) scale will be used to measure physical function, which is a well-established tool for monitoring function in older people, which contains three kinds of assessments: stand for 10 seconds with feet in 3 different positions, 3-meter or 4-meter walking speed test, and time to rise from a chair for five times. The scores of SPPB range from 0 (worst performance) to 12 (best performance). The minimum and maximum values are 0 and 10 respectively. Higher scores mean a better performance.

Changes of muscle mass

时间窗: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program

Muscle mass (kg) will be measured by using bioelectrical impedance analysis.

Changes of waist circumference

时间窗: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program

Waist circumference was taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.

Changes of fat mass

时间窗: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program

Fat mass (kg) will be measured by using bioelectrical impedance analysis.

次要结局

  • Mini Nutritional Assessment (MNA) Short-form(Change from baseline to 8 weeks, 3 months, and 6 months after completing the program)
  • EuroQoL 5D (EQ-5D)(Change from baseline to 8 weeks, 3 months, and 6 months after completing the program)
  • Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale(Change from baseline to 8 weeks, 3 months, and 6 months after completing the program)
  • Dietary Quality Index-International (DQI-I)(Change from baseline to 8 weeks, 3 months, and 6 months after completing the program)
  • Diet Adherence(Change from baseline to 8 weeks, 3 months, and 6 months after completing the program)
  • Exercise Adherence(Change from baseline to 8 weeks, 3 months, and 6 months after completing the program)

研究者

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

Dr. Justina Liu Yat Wa

Principal Investigator

The Hong Kong Polytechnic University

研究点 (1)

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