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

Opening soonNot applicableInterventional

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age65 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionSarcopenic Obesity

Full registry 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.

Treatments and study arms

Dietary modification intervention involving family support

Behavioral

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

Behavioral

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

Changes of muscle massChange from baseline to the end of intervention at 15 weeks

Muscle mass (kg) will be measured by using bioelectrical impedance analysis.

Changes of muscle strengthChange from baseline to the end of intervention at 15 weeks

Handgrip strength (kg) will be measured by using the digital dynamometer.

The Short Physical Performance Battery scaleChange 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 weightChange from baseline to the end of intervention at 15 weeks

Weight will be measured and recorded in kilograms

HeightChange from baseline to the end of intervention at 15 weeks

Height will be measured and recorded in meters.

Changes of body mass indexChange 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 fatChange from baseline to the end of intervention at 15 weeks

Percentage of body fat will be measured by using bioelectrical impedance analysis.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Hong Kong Polytechnic University🇭🇰 Hong Kong, Hong Kong