Clinical trial NCT06933823: Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults
Official title: Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenic Obesity
Keywords: Sarcopenic Obesity
Dietary intervention
Pilot RCT
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of muscle mass
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Changes of muscle strength
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: The Short Physical Performance Battery scale
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Change of weight
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Height
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Changes of body mass index
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Changes of percentage of body fat
timeFrame: Change from baseline to the end of intervention at 15 weeks
Secondary outcomes:
measure: Mini Nutritional Assessment (MNA) scale
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Dietary Quality International-Index (DQI-I)
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Diet adherence
timeFrame: Change from baseline to the end of intervention at 15 weeks
measure: Health action process approach(HAPA)Nutrition Self-efficacy Scale
timeFrame: Change from baseline to the end of intervention at 15 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Pui Ying Mak, BSN
role: PRINCIPAL_INVESTIGATOR
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