Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Sarcopenic Obesity

Treatments: Behavioral: Dietary modification intervention; Behavioral: Dietary modification intervention involving family support

Study type: Interventional

Funder types: Other

Identifiers

NCT06933823

HSEARS20241105001

Details and patient eligibility

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

Enrollment: 72 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

FamNUTRI group

Experimental group

Description:

The 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.

Treatment:

Behavioral: Dietary modification intervention involving family support

NUTRI group

Active Comparator group

Description:

The 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.

Treatment:

Behavioral: Dietary modification intervention

Control Group

No Intervention group

Description:

This control group will not receive any intervention and participants will be instructed to maintain their original dietary habits.