Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults
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interventional
72
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2025
CompletedStudy Start
First participant enrolled
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 18, 2025
April 1, 2025
1 year
April 2, 2025
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Changes of muscle mass
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Change from baseline to the end of intervention at 15 weeks
Changes of muscle strength
Handgrip strength (kg) will be measured by using the digital dynamometer.
Change from baseline to the end of intervention at 15 weeks
The Short Physical Performance Battery scale
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 from baseline to the end of intervention at 15 weeks
Change of weight
Weight will be measured and recorded in kilograms
Change from baseline to the end of intervention at 15 weeks
Height
Height will be measured and recorded in meters.
Change from baseline to the end of intervention at 15 weeks
Changes of body mass index
The weight and height will be combined to report BMI in kg/m\^2.
Change from baseline to the end of intervention at 15 weeks
Changes of percentage of body fat
Percentage of body fat will be measured by using bioelectrical impedance analysis.
Change from baseline to the end of intervention at 15 weeks
Secondary Outcomes (4)
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
Study Arms (3)
FamNUTRI group
EXPERIMENTALThe 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.
NUTRI group
ACTIVE COMPARATORThe 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.
Control Group
NO INTERVENTIONThis control group will not receive any intervention and participants will be instructed to maintain their original dietary habits.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Related Publications (48)
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Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Pui Ying Mak, BSN
The Hong Kong Polytechnic University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A blinded independent assessor will assess the participants' outcomes without knowing their group allocations.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 2, 2025
First Posted
April 18, 2025
Study Start
April 15, 2025
Primary Completion
April 15, 2026
Study Completion
May 1, 2026
Last Updated
April 18, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
To maintain confidentiality, all participant information will remain anonymous and replaced with reference codes. The collected data will be securely stored, with physical copies kept in a locked location and electronic files encrypted and accessible only to the research team. All data will be destroyed within seven years following the conclusion of this study.