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NCT Number: NCT06933823

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

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

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Key information

Conditions

Sarcopenic Obesity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • having a family member consent to offer support to the study participant
  • 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%
  • ability to read, write and understand Chinese without severe speaking, hearing and vision problems for intervention delivery.

Exclusion criteria

  • 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
  • having medications that impact dietary patterns, digestion, or metabolism
  • following specific dietary pattern or restrictions, such as diabetic diets and renal diets
  • 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
  • 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.

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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).

  4. Change of weight

    Time frame: Change from baseline to the end of intervention at 15 weeks

    Weight will be measured and recorded in kilograms

  5. Height

    Time frame: Change from baseline to the end of intervention at 15 weeks

    Height will be measured and recorded in meters.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pui Ying Mak, BSN

CONTACT

[email protected]

852 34008295

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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