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Sarcopenic ObesityNCT06933823

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

A study testing Dietary modification intervention involving family support and Dietary modification intervention in people with Sarcopenic Obesity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Sarcopenic Obesity
What is being tested?
Dietary modification intervention involving family support and Dietary modification intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteHong Kong
Study dates
15 Apr 2025to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pui Ying Mak, BSN contact

852 34008295

pui-ying-bobo.mak@connect.polyu.hk

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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?
Read more

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

Being tested
Dietary modification intervention involving family support, Dietary modification intervention
Keywords
Sarcopenic Obesity, Dietary intervention, Pilot RCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary modification intervention involving family supportBehavioural

    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 interventionBehavioural

    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.

Study groups in NCT06933823
Study groupRoleWhat they receive
FamNUTRI groupExperimentalThe 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.
Receives: Behavioral: Dietary modification intervention involving family support
NUTRI groupActive comparatorThe 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.
Receives: Behavioral: Dietary modification intervention
Control GroupNo interventionThis control group will not receive any intervention and participants will be instructed to maintain their original dietary habits.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of muscle mass

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

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

  2. Changes of muscle strength

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

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

  3. The Short Physical Performance Battery scale

    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).

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

  4. Change of weight

    Weight will be measured and recorded in kilograms

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

  5. Height

    Height will be measured and recorded in meters.

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

  6. Changes of body mass index

    The weight and height will be combined to report BMI in kg/m^2.

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

  7. Changes of percentage of body fat

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

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

Secondary outcomes (4)

  1. Mini Nutritional Assessment (MNA) scale

    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.

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

  2. Dietary Quality International-Index (DQI-I)

    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.

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

  3. Diet adherence

    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.

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

  4. Health action process approach(HAPA)Nutrition Self-efficacy Scale

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start15 Apr 2025 (estimated)
  3. Primary completion15 Apr 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06933823
Sponsor's protocol ID
HSEARS20241105001
Status last verified
Apr 2025
First submitted
2 Apr 2025
Last updated
18 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.

    PubMed 10811152

  • Zhou X, Perez-Cueto FJA, Santos QD, Monteleone E, Giboreau A, Appleton KM, Bjorner T, Bredie WLP, Hartwell H. A Systematic Review of Behavioural Interventions Promoting Healthy Eating among Older People. Nutrients. 2018 Jan 26;10(2):128. doi: 10.3390/nu10020128.

    PubMed 29373529

  • Gilbert SJ, Zamenopoulos T, Alexiou K, Johnson JH. Involvement of right dorsolateral prefrontal cortex in ill-structured design cognition: an fMRI study. Brain Res. 2010 Feb 2;1312:79-88. doi: 10.1016/j.brainres.2009.11.045. Epub 2009 Nov 27.

    PubMed 19948156

  • Willoughby D, Hewlings S, Kalman D. Body Composition Changes in Weight Loss: Strategies and Supplementation for Maintaining Lean Body Mass, a Brief Review. Nutrients. 2018 Dec 3;10(12):1876. doi: 10.3390/nu10121876.

    PubMed 30513859

  • Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.

    PubMed 28514618

  • Verjans-Janssen SRB, van de Kolk I, Van Kann DHH, Kremers SPJ, Gerards SMPL. Effectiveness of school-based physical activity and nutrition interventions with direct parental involvement on children's BMI and energy balance-related behaviors - A systematic review. PLoS One. 2018 Sep 27;13(9):e0204560. doi: 10.1371/journal.pone.0204560. eCollection 2018.

    PubMed 30261057

  • Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, Morley JE, Chumlea W, Salva A, Rubenstein LZ, Garry P. Overview of the MNA--Its history and challenges. J Nutr Health Aging. 2006 Nov-Dec;10(6):456-63; discussion 463-5.

    PubMed 17183418

  • Trouwborst I, Verreijen A, Memelink R, Massanet P, Boirie Y, Weijs P, Tieland M. Exercise and Nutrition Strategies to Counteract Sarcopenic Obesity. Nutrients. 2018 May 12;10(5):605. doi: 10.3390/nu10050605.

    PubMed 29757230

  • Sammarco R, Marra M, Di Guglielmo ML, Naccarato M, Contaldo F, Poggiogalle E, Donini LM, Pasanisi F. Evaluation of Hypocaloric Diet With Protein Supplementation in Middle-Aged Sarcopenic Obese Women: A Pilot Study. Obes Facts. 2017;10(3):160-167. doi: 10.1159/000468153. Epub 2017 May 20.

    PubMed 28528340

  • Rosland AM, Kieffer E, Israel B, Cofield M, Palmisano G, Sinco B, Spencer M, Heisler M. When is social support important? The association of family support and professional support with specific diabetes self-management behaviors. J Gen Intern Med. 2008 Dec;23(12):1992-9. doi: 10.1007/s11606-008-0814-7. Epub 2008 Oct 15.

    PubMed 18855075

  • Robinson SM, Reginster JY, Rizzoli R, Shaw SC, Kanis JA, Bautmans I, Bischoff-Ferrari H, Bruyere O, Cesari M, Dawson-Hughes B, Fielding RA, Kaufman JM, Landi F, Malafarina V, Rolland Y, van Loon LJ, Vellas B, Visser M, Cooper C; ESCEO working group. Does nutrition play a role in the prevention and management of sarcopenia? Clin Nutr. 2018 Aug;37(4):1121-1132. doi: 10.1016/j.clnu.2017.08.016. Epub 2017 Aug 24.

    PubMed 28927897

  • Peters MDJ, Godfrey C, McInerney P, Khalil H, Larsen P, Marnie C, Pollock D, Tricco AC, Munn Z. Best practice guidance and reporting items for the development of scoping review protocols. JBI Evid Synth. 2022 Apr 1;20(4):953-968. doi: 10.11124/JBIES-21-00242.

    PubMed 35102103

  • Phillips BE, Atherton PJ, Varadhan K, Limb MC, Wilkinson DJ, Sjoberg KA, Smith K, Williams JP. The effects of resistance exercise training on macro- and micro-circulatory responses to feeding and skeletal muscle protein anabolism in older men. J Physiol. 2015 Jun 15;593(12):2721-34. doi: 10.1113/JP270343. Epub 2015 May 14.

    PubMed 25867865

  • Pavasini R, Guralnik J, Brown JC, di Bari M, Cesari M, Landi F, Vaes B, Legrand D, Verghese J, Wang C, Stenholm S, Ferrucci L, Lai JC, Bartes AA, Espaulella J, Ferrer M, Lim JY, Ensrud KE, Cawthon P, Turusheva A, Frolova E, Rolland Y, Lauwers V, Corsonello A, Kirk GD, Ferrari R, Volpato S, Campo G. Short Physical Performance Battery and all-cause mortality: systematic review and meta-analysis. BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7.

    PubMed 28003033

  • Nilsson MI, Dobson JP, Greene NP, Wiggs MP, Shimkus KL, Wudeck EV, Davis AR, Laureano ML, Fluckey JD. Abnormal protein turnover and anabolic resistance to exercise in sarcopenic obesity. FASEB J. 2013 Oct;27(10):3905-16. doi: 10.1096/fj.12-224006. Epub 2013 Jun 26.

    PubMed 23804240

Questions about this trial

What is this clinical trial studying?

A study testing Dietary modification intervention involving family support and Dietary modification intervention in people with Sarcopenic Obesity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pui Ying Mak, BSN (852 34008295, pui-ying-bobo.mak@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of muscle mass (time frame: Change from baseline to the end of intervention at 15 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06933823, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.

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