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

April 17, 2025 updated by: Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University

Dietary Modification Intervention Involving Family Support (FamNUTRI) for Managing Sarcopenic Obesity Among Community-dwelling Older Adults: a Pilot Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FamNUTRI group
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.
Behavioral: 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.
Active Comparator: NUTRI group
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.
Behavioral: 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.
No Intervention: Control Group
This control group will not receive any intervention and participants will be instructed to maintain their original dietary habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of muscle mass
Time Frame: Change from baseline to the end of intervention at 15 weeks
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
Time Frame: Change from baseline to the end of intervention at 15 weeks
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
Time Frame: Change 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 from baseline to the end of intervention at 15 weeks
Change of weight
Time Frame: Change from baseline to the end of intervention at 15 weeks
Weight will be measured and recorded in kilograms
Change from baseline to the end of intervention at 15 weeks
Height
Time Frame: Change from baseline to the end of intervention at 15 weeks
Height will be measured and recorded in meters.
Change from baseline to the end of intervention at 15 weeks
Changes of body mass index
Time Frame: Change from baseline to the end of intervention at 15 weeks
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
Time Frame: Change from baseline to the end of intervention at 15 weeks
Percentage of body fat will be measured by using bioelectrical impedance analysis.
Change from baseline to the end of intervention at 15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Nutritional Assessment (MNA) scale
Time Frame: Change from baseline to the end of intervention at 15 weeks
The Mini Nutritional Assessment (MNA) scale will be used to measure the participants' nutritional status. Scores on the MNA range from 0 to 30, with higher scores indicating better nutritional status. Scoring 24-30 indicates normal nutritional status, scoring 17-23.5 indicates a risk of malnutrition, and scoring less than 17 indicates malnourished.
Change from baseline to the end of intervention at 15 weeks
Dietary Quality International-Index (DQI-I)
Time Frame: Change from baseline to the end of intervention at 15 weeks
The Dietary Quality International-Index (DQI-I) will be used to measure the dietary quality. The DQI-I assessed four aspects of diet which include variety, adequacy, moderation, and overall balance. Total scores on the DQI-I range from 0 to 100, with higher scores indicating a better quality of diet.
Change from baseline to the end of intervention at 15 weeks
Diet adherence
Time Frame: Change from baseline to the end of intervention at 15 weeks
Diet adherence will be measured by the protein intake and caloric restriction based on the 3-day dietary record. The adherence to protein intake will be reflected by the protein score in the DQI-I which will be calculated based on participant's 3-day dietary record. Also. the participants' attendance rate in the consultation sessions will be monitored.
Change from baseline to the end of intervention at 15 weeks
Health action process approach(HAPA)Nutrition Self-efficacy Scale
Time Frame: Change from baseline to the end of intervention at 15 weeks
The Nutrition Self-Efficacy Scale is a component of the Health-Specific Self-Efficacy Scale, created by Ralf Schwarzer and Britta Renner. It consists of 5 items, each rated on a 4-point Likert scale: 1 = Very Uncertain, 2 = Rather Uncertain, 3 = Rather Certain, and 4 = Very Certain. Higher scores indicate greater self-efficacy. The total scores range from 5 to 20.
Change from baseline to the end of intervention at 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Pui Ying Mak, BSN, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2025

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20241105001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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