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

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое 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 f
• Поведенческое 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.

Первичные конечные точки

• Changes of muscle mass [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Changes of muscle strength [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• The Short Physical Performance Battery scale [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Change of weight [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Height [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Changes of body mass index [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Changes of percentage of body fat [Срок оценки: Change from baseline to the end of intervention at 15 weeks]

Вторичные конечные точки (4)

• Mini Nutritional Assessment (MNA) scale [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Dietary Quality International-Index (DQI-I) [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Diet adherence [Срок оценки: Change from baseline to the end of intervention at 15 weeks]
• Health action process approach(HAPA)Nutrition Self-efficacy Scale [Срок оценки: Change from baseline to the end of intervention at 15 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Публикации

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• 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. PMID 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. PMID 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. PMID 29757230

Идентификаторы

NCT: NCT06933823 · HSEARS20241105001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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