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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FamNUTRI group | Experimental | 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. |
|
| NUTRI group | Active Comparator | 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. |
|
| Control Group | No Intervention | This control group will not receive any intervention and participants will be instructed to maintain their original dietary habits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of muscle mass | 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 | 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 | 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 | Weight will be measured and recorded in kilograms | Change from baseline to the end of intervention at 15 weeks |
| Height | Height will be measured and recorded in meters. | Change from baseline to the end of intervention at 15 weeks |
| Changes of body mass index | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to the end of intervention at 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pui Ying Mak, BSN | Contact | 852 34008295 | pui-ying-bobo.mak@connect.polyu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Pui Ying Mak, BSN | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10811152 | Background | 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. | |
| 29373529 |
| Label | URL |
|---|---|
| Inbody S10 | View source |
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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.
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A blinded independent assessor will assess the participants' outcomes without knowing their group allocations.
|
| 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. |
|
| Changes of percentage of body fat | Percentage of body fat will be measured by using bioelectrical impedance analysis. | Change from baseline to the end of intervention at 15 weeks |
| 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. | Change from baseline to the end of intervention at 15 weeks |
| 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. | Change from baseline to the end of intervention at 15 weeks |
| 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. | Change from baseline to the end of intervention at 15 weeks |
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| Food Processor | View source |