Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes of muscle strength
研究概览
简要总结
The goal of this pilot RCT is to examine the feasibility and preliminary effects of a dietary modification intervention involving family support (FamNUTRI) on the management of sarcopenic obesity among older people living in the community. The main questions it aims to answer are:
- Is the intervention feasible and acceptable for community-dwelling older people with sarcopenic obesity?
- What are the preliminary effects of the intervention on managing sarcopenic obesity in this population?
Researchers will compare the FamNUTRI group, the NUTRI group, and a passive control group to see if the dietary modification intervention with family support has additional benefits over the dietary modification intervention alone and no intervention.
Participants will:
Attend 6 face-to-face one-hour bi-weekly sessions over 15 weeks Receive bi-weekly phone calls to foster adherence to the hypocaloric diet with high protein intake (For the FamNUTRI group) Invite a family member to attend the sessions together
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
A blinded independent assessor will assess the participants' outcomes without knowing their group allocations.
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
- •older adults aged 65 years old or above who are living in the community and have not less than 4 shared meals with family weekly
- •having a family member consent to offer support to the study participant
- •diagnosed as having sarcopenic obesity using the diagnostic criteria of Asian Working Group for Sarcopenia (AWGS) for sarcopenia and definition from WHO for obesity for Asian, respectively: 3a)early-stage sarcopenia is defined by meeting one of the following criteria: low handgrip strength <28 kg for men and <18 kg for women, low appendicular skeletal muscle mass (ASM) /height2 < 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; 3b) Obesity is defined by meeting one of the following criteria: BMI ≥25 kg/m2, waist circumference ≥ 90 cm in men and ≥ 80 cm in women, or percentage of body fat >30%
- •ability to read, write and understand Chinese without severe speaking, hearing and vision problems for intervention delivery.
排除标准
- •having any existing disease or condition that affects digestion or food intake, such as severe heart diseases, renal diseases, depression or advanced stages of cancer
- •having medications that impact dietary patterns, digestion, or metabolism
- •following specific dietary pattern or restrictions, such as diabetic diets and renal diets
- •having alcohol addiction defined by Alcohol Use Disorders Identification Test (AUDIT) scoring 8 or above since it may affect their ability and their determination to make changes in dietary modification
- •having medical implants such as a pacemaker since the equipment to carry out bioelectric impedance analysis (Inbody S10) may cause malfunctioning of the implanted devices.
研究组 & 干预措施
FamNUTRI group
The experimental FamNUTRI group will receive dietary modification intervention in the older adult centre. A total of 6 face-to-face one-hour bi-weekly sessions of the dietary modification program combined with bi-weekly phone calls for the intervention period of 15 weeks to foster their adherence to the hypocaloric diet with high protein intake will be included in the intervention. They will be asked to invite one of their family members to attend the sessions together.
干预措施: Dietary modification intervention involving family support (Behavioral)
NUTRI group
The participants in NUTRI group will receive a total of 6 face-to-face one-hour bi-weekly sessions of the dietary modification program combined with bi-weekly phone calls for the intervention period of 15 weeks to foster their adherence to the hypocaloric diet with high protein intake.
干预措施: Dietary modification intervention (Behavioral)
Control Group
This control group will not receive any intervention and participants will be instructed to maintain their original dietary habits.
结局指标
主要结局
Changes of muscle strength
时间窗: Change from baseline to the end of intervention at 15 weeks
Handgrip strength (kg) will be measured by using the digital dynamometer.
Changes of muscle mass
时间窗: Change from baseline to the end of intervention at 15 weeks
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
The Short Physical Performance Battery scale
时间窗: Change from baseline to the end of intervention at 15 weeks
The Short Physical Performance Battery (SPPB) measures balance, lower extremity strength and functional capacity. It is a well-established tool for assessing physical function in older adults. It consists of three types of assessments: standing for 10 seconds with feet in three different positions, a 3-meter or 4-meter walking speed test, and the time to rise from a chair for five times. The final total SPPB score ranges from 4 to 12. Scores will be categorized as low performance (4-6), middle performance (7-9) and best performance (10-12).
Change of weight
时间窗: Change from baseline to the end of intervention at 15 weeks
Weight will be measured and recorded in kilograms
Height
时间窗: Change from baseline to the end of intervention at 15 weeks
Height will be measured and recorded in meters.
Changes of body mass index
时间窗: Change from baseline to the end of intervention at 15 weeks
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 the end of intervention at 15 weeks
Percentage of body fat will be measured by using bioelectrical impedance analysis.
次要结局
- Mini Nutritional Assessment (MNA) scale(Change from baseline to the end of intervention at 15 weeks)
- Dietary Quality International-Index (DQI-I)(Change from baseline to the end of intervention at 15 weeks)
- Diet adherence(Change from baseline to the end of intervention at 15 weeks)
- Health action process approach(HAPA)Nutrition Self-efficacy Scale(Change from baseline to the end of intervention at 15 weeks)
研究者
Dr. Justina Liu Yat Wa
Professor
The Hong Kong Polytechnic University