Clinical trial
Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults
Opening soon · Not applicable · 1 countries · Registry ID NCT06933823
What this study is about
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
Basic eligibility
Full registry criteria
Treatments and study arms
Dietary 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.
Dietary 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.
Primary outcomes
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Handgrip strength (kg) will be measured by using the digital dynamometer.
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).
Weight will be measured and recorded in kilograms
Height will be measured and recorded in meters.
The weight and height will be combined to report BMI in kg/m\^2.
Percentage of body fat will be measured by using bioelectrical impedance analysis.
Study locations
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