Effects of an Individualized Dietary Behavioural Change (IDBC) Programme and Exercise Training in Combination or Separately on Managing Sarcopenic Obesity in Community-dwelling Older Adults: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Changes of muscle mass
研究概览
简要总结
Sarcopenic obesity (SO) has synergistic detrimental effects on elderlies' health. It greatly increases the risk of cardio-metabolic diseases, physical impairment, institutionalization, and mortality when compared with sarcopenia or obesity alone. Effective interventions to simultaneously increase muscle mass and decrease fat mass are challenging but highly warranted. Research showed that exercise tends to produce better outcomes in SO than nutritional interventions. Inconsistent effects of nutritional interventions may be due to a short intervention duration and participants' poor compliance with nutritional advice. Participants' adherence to a dietary regimen is essential to the success of nutritional interventions. Behavior change techniques grounded in a tested effective theoretical model - the Health Action Process Approach [HAPA] model at improving participants' self-efficacy should be incorporated in a diet modification intervention.This project aims to investigate the effects of a HAPA-based individualized dietary behavior change (IDBC) intervention and exercise training, in combination and separately, for elderly with SO, to improve their body composition and physical functions. In this four-armed randomized controlled trial, investigators will recruit and randomize 380 elderly with SO to one of the following four groups: the combined (COMB) group, receiving the 24-week combined intervention consisting of the IDBC program and exercise training, the EXER-only group, receiving only the exercise training, the IDBC-only group, receiving a combination of the IDBC program and health talks, and the control group, receiving only health talks with no other intervention. Investigators will use health talks to control the group and social interaction effects of the group exercise training for the COMB and the EXER-only groups. Investigators hypothesize that participants in the COMB, EXER-only, and IDBC-only groups will have significantly better outcome measures middle of the intervention (T1), immediately (T2), at 3-months (T3), and 6-months (T4) post-intervention than those in the control group when compared to baseline (T0).
Investigators will use mixed-effects modeling to compare changes in all outcome variables at the three post-tests among the four groups. If our intervention is effective at mitigating or preventing such occurrences, the impact on public health will be significant. A similar intervention for other populations.
详细描述
Low muscle mass and high body fat mass often coexist in older adults, a condition known as sarcopenic obesity. Older adults with low muscle mass and strength are 1.95-2.62 times more likely to suffer from obesity than those with normal muscle mass. This is because both sarcopenia and obesity have common risk factors that include unhealthy lifestyles and age-related physiological changes with a decline in growth hormones, increased insulin resistance, and increased oxidative stress. Sarcopenic obesity has synergistic detrimental effects on physical functions and overall health. The risks of developing cardio-metabolic diseases, institutionalization, and mortality are higher than with sarcopenia or obesity alone. Depending on the diagnostic criteria, its prevalence can be up to 20.4% and 27.0% in women and men, respectively, in China and worldwide.
Effective interventions to simultaneously increase muscle mass and decrease body fat mass are challenging, but highly warranted. To date, only a limited number of trials have focused on managing sarcopenic obesity. The common proposed interventions are lifestyle interventions (i.e. exercise and a nutritional intervention). Unfortunately, evidence-based interventions are yet to be established due to diverse methodologies with inconsistent results in different clinical trials.
Exercise-based interventions: The current evidence shows that managing sarcopenic obesity with exercise interventions tends to produce better outcomes than with nutritional interventions. A recent systematic review of 15 trials with 856 participants revealed that the combination of aerobic and resistance exercise decreased fat mass and improved physical performance (i.e. gait speed). However, additional benefits could not be observed when combining a nutritional intervention and exercise. Another systematic review of eight RCTs with 605 participants observed 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. Another systematic review of seven RCTs with 558 participants also reported that exercise alone or combined with dietary supplements showed beneficial effects on increasing muscle mass and physical functions in this population. In summary, exercise, especially the combination of resistance and aerobic training, improves body composition and physical performance in older adults with sarcopenic obesity. However, the additional beneficial effects of combining exercise and nutritional interventions were inconsistent.
Nutrition-based interventions: However, nutritional intervention should not be ignored in managing sarcopenic obesity, as unhealthy diet habit is a key factor to develop both sarcopenia (i.e. a result of an inadequate protein intake) and obesity (i.e. a result of an excess calories consumption). Studies suggest that adequate protein intake is essential for building muscles, whereas caloric restriction effectively reduces fat mass. Several studies demonstrated that a hypocaloric diet was effective in reducing fat mass in older adults with sarcopenic obesity. However, this fat mass loss is often accompanied with muscle mass loss. Therefore, a weight loss diet in this population should also focus on preserving muscle mass. Protein, particularly animal-based protein, which contains leucine, can prevent loss of muscle mass associated with weight reduction and maintain physical performance. Although dietary supplements are commonly used to increase protein intake, their effects on sarcopenic obesity remain inconsistent. Protein supplements may cause side effects, including dehydration, liver and renal damage, bloating, and calcium loss. Investigators argue that people should not only take dietary supplements but foods and meals containing a whole range of interacting constituents, which is also one of the points emphasized in the Dietary Guidelines for Americans, 2020-2025. Therefore, investigators believe that modifying the daily diet habits of people with sarcopenic obesity is more appropriate and may produce long-term benefits than solely giving them dietary supplements.
To date, only two intervention studies have attempted to modify the dietary habits of older adults with sarcopenic obesity. The first RCT compared the effects of a hypocaloric normal protein diet (0.8 g/kg body weight/day) and a hypocaloric high protein diet (1.2 g/kg body weight/day) for 3 months in 104 older women. The results showed a significant reduction in muscle mass associated with fat mass loss in the normal protein intake group, but increased muscle mass in the high protein group. This study provided preliminary evidence that a hypocaloric diet moderately rich in proteins was able to preserve muscle mass in their participants. Another pilot RCT found a significant reduction in muscle mass in a hypocaloric diet plus placebo group compared with a hypocaloric high-protein group (1.2-1.4 g / kg body weight / day) during a 4-month diet control regimen involving 18 women. The preliminary results showed that muscle strength improved significantly in the high-protein intake group, while no observable differences in fat free mass were observed in both groups. Some limitations were observed in these two studies, including the use of loose screening criteria for sarcopenic obesity without referring to a commonly accepted diagnostic standard, little information on the participants' compliance with the dietary regimen, and an unclear randomization process and intervention components. Further studies are required to examine the effects of using a diet modification approach on sarcopenic obesity in a rigorous manner.
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
- 否
入选标准
- •community-dwelling older people aged > 65 years
- •who meet the diagnostic criteria of sarcopenic obesity according to the Asian Sarcopenia Working Group (ASWG)41 and the WHO definition of obesity for the Asian population, respectively: 2a) Early stage sarcopenia refers to the fulfillment of one of the following criteria: low handgrip strength < 28 kg for men and < 18 kg for women, low muscle quality as reflected by low appendicular skeletal muscle mass (ASM) /height squared < 7 kg/m2 for men and <5.7 kg/m2 for women, or low physical performance with a Short Physical Performance Battery (SPPB) score of < 9; 2b) Obesity refers to the fulfillment of one of the following criteria: BMI ≥ 23kg/m2 or waist circumference ≥ 90 cm in men and ≥ 80 cm in women, or percentage of body fat > 30%;
- •able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure that our instructions are understood.
排除标准
- •those with any form of disease or condition that might affect food intake and digestion (such as severe heart or lung diseases, renal diseases, diabetes, cancer, or autoimmune diseases);
- •taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication);
- •being addicted to alcohol, which might affect the effort to change dietary behaviour;
- •having impaired mobility, which might affect participation in exercise training, as defined by a modified Functional Ambulatory Classification score of < 7; ) having any medical implant device such as a pacemaker, because low-level currents will flow through the body when doing the bioelectric impedance analysis (BIA by InBody s10, Korea), which may cause the device to malfunction.
研究组 & 干预措施
The COMB group
Participants in The COMB group will be grounded on the HAPA model and piloted by the team. It consists of three phases with 10 face-to-face hourly sessions nested with weekly telephone calls to enhance the participants' adherence to dietary behavioral change. And will be group-based, and offered weekly for about 60 minutes during the execution phase (a total 20 sessions from weeks 4-24). The combination of resistance and aerobic exercises can improve muscle quantity and strength as well as reduce body fat in people with sarcopenic obesity, and will be adopted in this study.
干预措施: The Individualized Dietary Behavioural Change Programme (IDBC) (Behavioral)
The COMB group
Participants in The COMB group will be grounded on the HAPA model and piloted by the team. It consists of three phases with 10 face-to-face hourly sessions nested with weekly telephone calls to enhance the participants' adherence to dietary behavioral change. And will be group-based, and offered weekly for about 60 minutes during the execution phase (a total 20 sessions from weeks 4-24). The combination of resistance and aerobic exercises can improve muscle quantity and strength as well as reduce body fat in people with sarcopenic obesity, and will be adopted in this study.
干预措施: The Exercise Training (Behavioral)
The EXER-only group
Participants in The EXER-only group will be group-based, and offered weekly for about 60 minutes during the execution phase (a total 20 sessions from weeks 4-24). The combination of resistance and aerobic exercises can improve muscle quantity and strength as well as reduce body fat in people with sarcopenic obesity, and will be adopted in this study.
干预措施: The Exercise Training (Behavioral)
The IDBC-only group
Participants in The IDBC-only group will be grounded on the HAPA model and piloted by the team. It consists of three phases with 10 face-to-face hourly sessions nested with weekly telephone calls to enhance the participants' adherence to dietary behavioral change. And attend centre-based health talks about the management of different health issues with the exception of sarcopenic obesity.
干预措施: The Individualized Dietary Behavioural Change Programme (IDBC) (Behavioral)
The Control Group
Participants in The Control Group will attend centre-based health talks about the management of different health issues with the exception of sarcopenic obesity. As the purpose of the health talk is to control the group interactive effect in exercise training, the group size, and the frequency and the time of the health talks will be similar to those offered in the exercise programme for the COMB and EXER-only groups.
结局指标
主要结局
Changes of muscle mass
时间窗: Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
The Short Physical Performance Battery (SPPB) scale
时间窗: Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme
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 unabbreviated scale title: The Short Physical Performance Battery (SPPB) scale The minimum and maximum values: 0, 10 Higher scores mean a better performance
Waist circumference
时间窗: Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme
To estimate your potential disease risk is to measure your waist circumference. Excessive abdominal fat may be serious because it places you at greater risk for developing obesity-related conditions, such as Type 2 Diabetes, high blood pressure, and coronary artery disease.
Changes of muscle strength
时间窗: Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme
Handgrip strength (kg) will be measured by using the jamar dynamometer.
Changes of body mass index
时间窗: Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme
The weight and height will be combined to report BMI in kg/m\^2.
Changes of fat mass
时间窗: Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme
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 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme)
- Diet Adherence(Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme)
- Health action process approach(HAPA)Nutrition Self-efficacy Scale(Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme)
- Dietary quality index-International (DQI-I)(Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme)
- Exercise Adherence(Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme)
研究者
Dr. Justina Liu Yat Wa
Principal Investigator
The Hong Kong Polytechnic University
