Sarcopenic Obesity
Conditions
Keywords
Sarcopenic Obesity, Dietary intervention, Pilot RCT
Brief summary
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: 1. Is the intervention feasible and acceptable for community-dwelling older people with sarcopenic obesity? 2. 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
Interventions
BEHAVIORALDietary modification intervention involving family support
The intervention includes six one-hour, bi-weekly face-to-face sessions, along with bi-weekly phone calls over 15 weeks, to support participants in adhering to a hypocaloric and high-protein diet. The participants will be asked to invite one of their family members to attend the sessions together. Family members will be engaged in discussions to help enhance the participant's adherence to the recommended diet regimen. The aims of the sessions are to raise awareness among participants and their families about sarcopenia obesity and the recommended dietary modifications, emphasizing the critical role of family in supporting adherence to these changes. It also focuses on boosting participants' motivation, reducing barriers to dietary adjustments, and enhancing family-driven social support to help sustain long-term adherence to the prescribed regimen.
BEHAVIORALDietary modification intervention
The intervention includes six one-hour, bi-weekly face-to-face sessions, along with bi-weekly phone calls over 15 weeks, to support participants in adhering to a hypocaloric and high-protein diet. The sessions will only focus on educating the participants on following the dietary regimen and addressing the barriers they may encounter during dietary modification without family involving in the intervention.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A blinded independent assessor will assess the participants' outcomes without knowing their group allocations.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. having a family member consent to offer support to the study participant 3. 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% 4. ability to read, write and understand Chinese without severe speaking, hearing and vision problems for intervention delivery.
Exclusion criteria
1. 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 2. having medications that impact dietary patterns, digestion, or metabolism 3. following specific dietary pattern or restrictions, such as diabetic diets and renal diets 4. 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 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of percentage of body fat | Change from baseline to the end of intervention at 15 weeks | Percentage of body fat will be measured by using bioelectrical impedance analysis. |
| The Short Physical Performance Battery scale | 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 | Change from baseline to the end of intervention at 15 weeks | Weight will be measured and recorded in kilograms |
| Height | Change from baseline to the end of intervention at 15 weeks | Height will be measured and recorded in meters. |
| Changes of body mass index | 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 muscle mass | Change from baseline to the end of intervention at 15 weeks | Muscle mass (kg) will be measured by using bioelectrical impedance analysis. |
| Changes of muscle strength | Change from baseline to the end of intervention at 15 weeks | Handgrip strength (kg) will be measured by using the digital dynamometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Quality International-Index (DQI-I) | Change from baseline to the end of intervention at 15 weeks | The Dietary Quality International-Index (DQI-I) will be used to measure the dietary quality. The DQI-I assessed four aspects of diet which include variety, adequacy, moderation, and overall balance. Total scores on the DQI-I range from 0 to 100, with higher scores indicating a better quality of diet. |
| Diet adherence | Change from baseline to the end of intervention at 15 weeks | Diet adherence will be measured by the protein intake and caloric restriction based on the 3-day dietary record. The adherence to protein intake will be reflected by the protein score in the DQI-I which will be calculated based on participant's 3-day dietary record. Also. the participants' attendance rate in the consultation sessions will be monitored. |
| Health action process approach(HAPA)Nutrition Self-efficacy Scale | Change from baseline to the end of intervention at 15 weeks | The Nutrition Self-Efficacy Scale is a component of the Health-Specific Self-Efficacy Scale, created by Ralf Schwarzer and Britta Renner. It consists of 5 items, each rated on a 4-point Likert scale: 1 = Very Uncertain, 2 = Rather Uncertain, 3 = Rather Certain, and 4 = Very Certain. Higher scores indicate greater self-efficacy. The total scores range from 5 to 20. |
| Mini Nutritional Assessment (MNA) scale | Change from baseline to the end of intervention at 15 weeks | The Mini Nutritional Assessment (MNA) scale will be used to measure the participants' nutritional status. Scores on the MNA range from 0 to 30, with higher scores indicating better nutritional status. Scoring 24-30 indicates normal nutritional status, scoring 17-23.5 indicates a risk of malnutrition, and scoring less than 17 indicates malnourished. |
Countries
Hong Kong
Contacts
Primary ContactPui Ying Mak, BSN
Outcome results
None listed