Dietary Behaviour Change Intervention on Managing Sarcopenic Obesity in Community-dwelling Older People: a Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of body weight
研究概览
简要总结
The aim of this study is to evaluate the feasibility and preliminary effects of dietary behavior change intervention on the management of sarcopenic obesity (SO) among older people in the community.
The feasibility and preliminary effects of the intervention will be tested using a two-armed pilot randomized controlled trial among older people (N=60) with SO in the community in Nanjing, China. Finally, 10 participants will be invited to join a semi-structured interview to explore their perceptions about the whole intervention process.
It is hypothesized that the experimental group will have a greater improvement in the body composition, muscle strength and physical function compared to the control group after receiving the 15-week dietary behavior change intervention.
详细描述
The pilot study is a single-blind, two-arm randomized controlled trial. A total of 60 subjects (60 years old or more) are planned to be recruited. The subjects will be randomly divided into 2 groups witht a ratio of 1:1. One is the experimental group and the other is the control group.
The experimental group will receive 15 weeks of dietary intervention, including 6 face-to-face meetings and weekly telephone call. Each meeting lasts for 1 hour. The participants in the experimental group are required to control of calorie intake (decrease energy intake by 12%) and increase protein intake (1.2-1.5 g/body weight kg/day), and take dietary diary.
The control group will not receive any dietary interventions. They will only receive regular contacts with a similar frequency as the experimental group. The content of the conversations will not involve any topics related to SO.
After the intervention, 10-15 people from the experimental group will be randomly selected to receive semi-structured individual interview, which will last around 1 hour. The researcher plan to understand their feelings about participating in the study.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •community-dwelling older people aged 60 years old or above;
- •handgrip strength < 28 kg for men and < 18 kg for women;
- •BMI ≥ 28% or waist circumference ≥ 85 cm in men and ≥ 80 cm in women;
- •be able to read and write without severe hearing and vision problems.
排除标准
- •suffering from severe heart disease or metabolic disorders (e.g. renal diseases, diabetes) or autoimmune disease, cancer, or any other diseases/ conditions which may affect food intake and digestion or amputee;
- •cognitively impaired (e.g. dementia) may impede the delivery of the intervention;
- •under special diet restriction such as on diabetes disease diet, vegetarian, ketogenic diet, etc.;
- •using of medications that may influence eating behavior, digestion or metabolism (such as weight loss medication);
- •addicted to alcohol;
- •a metal device is implanted in the body;
- •be engaged in another trials.
结局指标
主要结局
Changes of body weight
时间窗: Change from baseline to 1 week after the programme
Body weight (kg) will be measured.
Changes of physical function
时间窗: Change from baseline to 1 week 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).
Changes of visceral fat score
时间窗: Change from baseline to 1 week after the programme
Visceral fat score will be measured by using bioelectrical impedance analysis. Maintain a visceral fat score below 10 means good health.
Recruitment rate
时间窗: Baseline
The proportion of participants who consent to join the study over the eligible participants.
Changes of skeletal muscle mass
时间窗: Change from baseline to 1 week after the programme
Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of muscle strength
时间窗: Change from baseline to 1 week after the programme
Handgrip strength (kg) will be measured by using the jamar dynamometer.
Adherence to diet regimen
时间窗: Throughout the 15-week programme
Diet adherence will be assessed by the session attendance (Rate of attendance in 6 sessions).
Occurrence of adverse events
时间窗: Throughout the 15-week programme
Any adverse events at home will be recorded.
Changes of fat mass
时间窗: Change from baseline to 1 week after the programme
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of body mass index
时间窗: Change from baseline to 1 week after the programme
The weight and height will be combined to report BMI in kg/m\^2.
Changes of percentage of body fat
时间窗: Change from baseline to 1 week after the programme
Percentage of body fat will be reported by the percent of body fat mass in whole body weight.
Changes of waist-to-hip ratio
时间窗: Change from baseline to 1 week after the programme
Waist circumference(cm) and hip circumference (cm) will be measured to report the waist-to-hip ratio.
Attrition rate
时间窗: At the end of the 15-week programme
The percentage of participants who withdraw from the study and their reasons for withdrawing.
次要结局
- Nutrition Self-efficacy Scale(Change from baseline to 1 week after the programme)
- Dietary quality index-International(Change from baseline to 1 week after the programme)
- Mini Nutritional Assessment (MNA) Short-form(Change from baseline to 1 week after the programme)
- Short Form Health Survey (SF-36)(Change from baseline to 1 week after the programme)
- International Physical Activity Questionnaire Short-form (IPAQ-SF)(Change from baseline to 1 week after the programme)
研究者
Dr. Justina Liu Yat Wa
Associate Professor
The Hong Kong Polytechnic University