[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659770":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":66,"studyPopulation":55,"armGroups":67,"interventions":81,"overallOfficials":95,"centralContacts":99,"locations":108,"responsibleParty":118,"collaborators":55,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":55,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":55,"enrollmentInfo":130,"targetDuration":55,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":144,"whyStopped":55,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":55},[9,13,17,20,23,26],{"measure":10,"description":11,"timeFrame":12},"Muscle Strength","Handgrip strength (kg) will be measured by using a Takei TKK5401 digital hand dynamometer.","From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program",{"measure":14,"description":15,"timeFrame":16},"Muscle Quantity","Muscle mass (kg) will be measured by using bioelectrical impedance analysis (InBody S10, Korea).","From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.",{"measure":18,"description":19,"timeFrame":16},"Body Mass Index (BMI)","The weight and height will be combined to report BMI in kg\u002Fm\\^2.",{"measure":21,"description":22,"timeFrame":16},"Waist Circumference","Waist circumference was taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.",{"measure":24,"description":25,"timeFrame":16},"Fat Mass","Fat mass (kg) will be measured by using bioelectrical impedance analysis (S10, Korea).",{"measure":27,"description":28,"timeFrame":16},"The Short Physical Performance Battery (SPPB) scale","The Short Physical Performance Battery (SPPB) scale will be used to measure physical function, which is a well-established tool for monitoring function in older people, which contains three kinds of assessments: stand for 10 seconds with feet in 3 different positions, 3-meter or 4-meter walking speed test, and time to rise from a chair for five times. The scores of SPPB range from 0 (worst performance) to 12 (best performance). The minimum and maximum values are 0 and 10 respectively. Higher scores mean a better performance.",[30,33,36,39,42,45,48,52],{"measure":31,"description":32,"timeFrame":16},"Mini Nutritional Assessment (MNA) Short-form","Participants' nutritional status will be assessed through the Mini Nutritional Assessment (MNA). It is a simple and quick tool for assessing older people who are malnourished or at risk of malnutrition. The MNA Short-form contains 6 items. Questions are weighted, 2-3 points per item. Scores are categorised as 0-7 (malnourished), 8-11 (at risk of malnutrition), 12-14 (normal nutritional status). The minimum and maximum values are 0 and 14 respectively. Higher scores mean a better nutritional status.",{"measure":34,"description":35,"timeFrame":16},"Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale","The nutrition self-efficacy scale is one part of the Health-Specific Self-efficacy Scale. The nutritional self-efficacy scale is a 5-item scale, and each item is rated on 4-point likert scale from 1= very uncertain, 2=rather uncertain, 3=rather certain, 4=very certain. Higher score means higher self-efficacy. The minimum and maximum values are 0 and 20 respectively. Higher scores mean a higher self-efficacy.",{"measure":37,"description":38,"timeFrame":16},"Dietary Quality Index-International (DQI-I)","The DQI-I will be used to estimate the dietary quality of participants. It is a well-used questionnaire without being affected by culture. The total scores range from 0 to 100, with a higher score representing better diet quality. The minimum and maximum values are 0 and 100 respectively. Higher scores mean a better diet quality.",{"measure":40,"description":41,"timeFrame":16},"EuroQoL 5D-5L (EQ-5D-5L)","The EQ-5D-5L comprises five dimensions of health: mobility, self-care, usual activities, pain \u002F discomfort, and anxiety\u002Fdepression. Each of them has five severity levels: no problems, slight problems, moderate problems, severe problems, or extreme problems, and a 0-100 points visual analogue scale (EQ VAS). The ratings from the five categories can be transformed into a utility index score by utilizing the scores derived from the preference weights of the general population in Hong Kong. The utility score generally ranges from less than 0 to 1. A higher score indicates higher health utility. The EQ VAS ranges from 0 to 100, with higher scores indicate better imaginable health.",{"measure":43,"description":44,"timeFrame":16},"Diet Adherence","The adherence of total caloric and other nutrient intakes will be analyzed by a software program \"Food Processor®\". If any participant forgets to keep the dietary record, the dietitian will employ the 3-day food recall method to check their food intake, a standard approach in nutritional studies. Participants' consultation session attendance rates will also be monitored.",{"measure":46,"description":47,"timeFrame":16},"Exercise Adherence","Assessed based on attendance in the weekly exercise training sessions and self-reported adherence to the exercise regimen on an 11-point Likert scale with 0 = poorest compliance; 10 = highest compliance.",{"measure":49,"description":50,"timeFrame":51},"Mobile Application Rating Scale (uMARS)","The uMARS is used to assess the app usage experience among participants in M-health group. Participants will also be invited in focus groups at the 3- and 12-month follow-ups to explore the participants' perceptions of the usefulness, ease of use, attitude toward using, and intention to use the App.","From 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.",{"measure":53,"description":54,"timeFrame":16},"Health service utilization","Health service utilization will be collected using a self-reported questionnaire, capturing the number, frequency, reasons, and duration of hospital stays, emergency room and clinical visits at each measurement point.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","A two-arm, assessor-blinded, parallel design randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWelLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related elements.","TREATMENT",{"masking":62,"maskingDescription":63,"whoMasked":64},"SINGLE","A biostatistician who will randomize group assignment as well as final data analyses",[65],"OUTCOMES_ASSESSOR","Background Sarcopenic obesity (SO), characterized by reduced muscle mass alongside excess body fat, affects 9.95% of Chinese1 and 11% worldwide2, with prevalence exceeding 23% among those 75+1,2.. SO poses greater risks of osteoarthritis, cardio-metabolic diseases, institutionalization, and mortality, than sarcopenia or obesity alone3. Healthcare costs for obese individuals are triple those of individuals with normal BMI (US$16,348 vs US$5,814)4. Sarcopenia alone accounted for an estimated US$18.5 billion in 2000 (1.5% of total healthcare expenditures), with a 10% reduction in prevalence potentially saving US$1.1 billion5. SO's economic burden likely amplifies these costs, highlighting the need for targeted interventions.\n\nMobile health (m-Health) applications offer a convenient, personalized, and cost-effective alternative to traditional care. Features such as self-monitoring, automated feedback, and interactive messaging enhance treatment adherence, foster peer support, and overcome the barriers of in-person consultations6,7. While evidence shows apps significantly improve nutritional behaviors in chronic disease management, maintaining long-term user engagement remains a challenge8.\n\nCurrently, a critical research gap exists: no nutritional app specifically targets SO to support mandatory low-calorie, high-protein diets. The proposed EatWelLog App aims to bridge this gap. By encouraging healthy dietary habits, evaluating long-term usage data, and linking engagement patterns to health outcomes, this digital intervention has the potential to revolutionize SO management and deliver sustainable, cost-effective health outcomes.\n\nStudy Objectives \\& Hypotheses Objectives: The study aims to evaluate the effects of an mHealth-based intervention using the EatWelLog App, developed by our research team, to empower people's self-management of a healthy diet and thereby improve their sarcopenic obesity status. The expected benefits include reducing body fat and improving muscle health.\n\nHypotheses: Compared with the control group receiving the same supervised nutrition and exercise programme without the App, the mHealth group using the App during and after the supervised programme will demonstrate sustained improvements in sarcopenic obesity status.\n\nStudy Design \\& Methodology Study Design: The study will adopt a two-arm, assessor-blinded, parallel-group randomized controlled trial design.\n\n* An m-Health group receiving an 8-week supervised nutrition and exercise programme, and training to incorporate the App for daily dietary management,\n* A control group receiving the identical 8-week supervised programme without the App.\n\nParticipants:\n\nSample size: 212 (106 per group) community-dwelling older people with SO\n\nInclusion criteria:\n\n1. Age 50+;\n2. Having SO according to the Asian Working Group for Sarcopenia (AWGS)9 and the WHO's obesity criteria for Asians9:\n\n   1. Early-stage sarcopenia refers to the fulfillment both of the following criteria:\n   2. For participants aged 50-64: low handgrip strength \\\u003C 34 kg for men and \\\u003C 20 kg for women, low muscle quality as reflected by low appendicular skeletal muscle mass (ASM) \u002Fheight squared \\\u003C 7.6 kg\u002Fm2 for men and \\\u003C5.7 kg\u002Fm2 for women. For participants aged 65 or above: handgrip strength \\\u003C28kg (men) and \\\u003C18 kg (women); appendicular skeletal muscle mass (ASM)\u002F height2 \\\u003C7 kg\u002Fm2 (men) and \\\u003C5.7 kg\u002Fm2 (women).\n   3. Obesity is indicated by BMI ≥25 kg\u002Fm2, waist circumference ≥90 cm (men) and ≥80 cm (women)9, or body fat \\>30%10. fulfil either one criterion to indicate the status of obesity.\n3. Smartphone owners with internet access\n4. Chinese (Cantonese) literacy and no significant sensory impairments\n\nExclusion criteria: Individuals who:\n\n1. have diseases that impact digestion or food consumption, including severe cardiac\u002F pulmonary\u002F renal diseases, diabetes, cancer, or autoimmune disorders.\n2. are on medications that affect eating habits\u002F digestion\u002F metabolism, such as weight loss drugs.\n3. have alcohol use disorder as defined by the Manual of Mental Disorder (DSM-5), which may hinder dietary behaviour changes.\n4. have medical implants like pacemakers that could be disrupted by the low-level electrical currents of the bioelectric impedance analysis (BIA).\n5. have a Functional Ambulatory Classification (FAC)11 score of \\\u003C7, indicating impaired mobility to participate in exercise training\n\nFocus group: Thirty m-Health participants will be divided into 5-8 focus group (4-6 participants per group) for interviewed by a trained research assistant (RA) to understand their App user experiences.\n\nInterventions:\n\nBoth groups will separately receive an 8-week supervised programme including a personalized dietary modification programme and group-based exercise. The research team's involvement will conclude after the programme for both groups. However, the m-Health group will continue using the App for daily dietary self-management during and after the programme.\n\nThe 8-week Intervention components for both the m-Health and control groups:\n\n* Dietary modification programme: aims to improve the participants' self-efficacy in adopting our previously validated diet regimen\\*12,13. It includes eight personalized, one-hour, face-to-face sessions.\n* \\*Dietary Regimen: a moderate hypocaloric diet reduces daily energy intake by 12% for steady weight loss while preserving muscle mass9. To address the reduced anabolic response in older people, a protein intake of 1.5 g\u002Fkg of body weight per day is recommended, with leucine-rich animal proteins prioritized to enhance muscle development9.\n* Exercise Training: involves weekly one-hour group sessions for 8 weeks, with groups of approximately ten. The training combines resistance and aerobic exercises to increase muscle mass and strength while reducing fat in SO individuals7. Each session includes a 10-minute warm-up and cool-down period, 20 minutes of resistance training, and 20 minutes of brisk walking, supervised by an instructor for practice and feedback. Participants will receive a YouTube link and pamphlet detailing exercises to follow 30 minutes daily, five times a week, during and after the programme.\n\nIntervention components for the m-Health group:\n\n• The EatWelLog App: designed for older people with SO, incorporates Klasnja and Pratt's m-health development framework to facilitate health behavioural change7 by integrating BCT14 to support ongoing adherence to dietary regimens.\n\nThe control condition:\n\n• After the 8-week programme (identical to the mHealth group but conducted separately), the control group will be encouraged to follow dietary and exercise guidelines independently, with no further formal interactions or training. To ensure they are not deprived of the App's benefits, they will receive a training session on using the App and full access to it after completing the 12-month follow up.",[68,76],{"label":69,"type":70,"description":71,"interventionNames":72},"M-Health Group","EXPERIMENTAL","M-Health group will receive an 8-week supervised nutrition and exercise programme, and training to incorporate the EatWelLog App for daily dietary management.",[73,74,75],"Behavioral: Dietary Modification programme","Behavioral: Exercise Training","Behavioral: The EatWelLog App",{"label":77,"type":78,"description":79,"interventionNames":80},"Control Group","SHAM_COMPARATOR","Control group will receive the identical 8-week supervised programme without using the EatWelLog App.",[73,74],[82,87,91],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":55},"BEHAVIORAL","Dietary Modification programme","• This programme aims to improve the participants' self-efficacy in adopting our previously validated diet regimen\\*. It includes 3 personalized, one-hour, face-to-face sessions in weeks 1, 3 and 7 conducted by a dietitian plus 5 dietary related health talks in the remaining weeks (i.e. Week 2, 4-6, 8)\n\n* Dietary Regimen: a moderate hypocaloric diet reduces daily energy intake by 12% for steady weight loss while preserving muscle mass9. To address the reduced anabolic response in older people, a protein intake of 1.5 g\u002Fkg of body weight per day is recommended, with leucine-rich animal proteins prioritized to enhance muscle development9",[77,69],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":55},"Exercise Training","Participants will receive an 8-week exercise training during the programme. The training combines resistance and aerobic exercises to increase muscle mass and strength while reducing fat in individual with SO. Participants will receive a YouTube link and pamphlet detailing exercises to follow 30 minutes daily, five times a week, during and after the programme.",[77,69],{"type":83,"name":92,"description":93,"armGroupLabels":94,"otherNames":55},"The EatWelLog App","Participants in the M-health group will be instructed to use the EatWelLog App for daily diet self-management. This App supports participants with SO by providing a structured approach to managing a diet that encourages steady weight loss while maintaining muscle mass. Nutritional recommendations will be also be provided according to individuals' demographic information.",[69],[96],{"name":97,"affiliation":5,"role":98},"Justina Liu, PhD","PRINCIPAL_INVESTIGATOR",[100,104],{"name":97,"role":101,"phone":102,"phoneExt":55,"email":103},"CONTACT","+852 2766 4097","justina.liu@polyu.edu.hk",{"name":105,"role":101,"phone":106,"phoneExt":55,"email":107},"Jackie Yeung","+852 2766 6427","jackie.yeung@polyu.edu.hk",[109],{"facility":5,"status":55,"city":110,"state":55,"zip":55,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":55},"Hong Kong","HK",{"type":113,"coordinates":114},"Point",[115,116],114.17469,22.27832,{"lat":116,"lon":115},{"type":98,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Dr. Justina Liu Yat Wa","Associate Head & Professor","100659770","effects-of-the-eatwellog-app-on-enhancing-diet-management-for-older-adults-with-sarcopenic-obesity-100659770",false,"NCT07867795","Effects of the EatWelLog App on Enhancing Diet Management for Older Adults With Sarcopenic Obesity","Effects of the EatWelLog App on Enhancing Daily Diet Management for Community-dwelling Older Adults With Sarcopenic Obesity: A Randomized Controlled Trial (RCT)","Inclusion Criteria:\n\n* Community-dwelling older people aged \\> 50 years;\n* Meeting the diagnostic criteria of sarcopenia according to the Asian Sarcopenia Working Group (ASWG) which include:\n* Sarcopenia refers to the fulfillment both of the following criteria: For participants aged 50-64: low handgrip strength \\\u003C 34 kg for men and \\\u003C 20 kg for women, low muscle quality as reflected by low appendicular skeletal muscle mass (ASM) \u002Fheight squared \\\u003C 7.6 kg\u002Fm2 for men and \\\u003C5.7 kg\u002Fm2 for women. For participants aged 65 or above: handgrip strength \\\u003C28kg (men) and \\\u003C18 kg (women); appendicular skeletal muscle mass (ASM)\u002F height2 \\\u003C7 kg\u002Fm2 (men) and \\\u003C5.7 kg\u002Fm2 (women).\n* Obesity refers to the fulfillment of one of the following criteria: Body Mass Index (BMI) ≥ 25kg\u002Fm2 or waist circumference ≥ 90 cm in men and ≥ 80 cm in women, or percentage of body fat \\> 30%.\n* Able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure that our instructions are understood; and • Own a smartphone, and able to access the internet at home or elsewhere.\n\nExclusion Criteria:\n\n* With any form of disease or condition that might affect food intake and digestion (such as severe heart or lung diseases, renal diseases, diabetes, cancer, or autoimmune diseases);\n* Taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication);\n* With alcohol use disorder as defined by DSM-5, potentially hindering dietary behaviour changes; and\n* Having any medical implant device such as a pacemaker, because low-level currents will flow through the body when doing the bioelectric impedance analysis (BIA by InBody S10, Korea), which may cause the device to malfunction.\n* Have a Functional Ambulatory Classification (FAC) score of \\\u003C7, indicating impaired mobility to participate in exercise training.","ALL","50 Years",{"count":131,"type":132},212,"ESTIMATED","INTERVENTIONAL",[135],"NA","Background: Sarcopenic obesity (SO) affects 10% of older adults increased to 23% of those 75+, raising health risks and health cost.\n\nObjectives: We will evaluate the effects of the EatWelLog App-based intervention on SO status (primary outcome), and nutritional and exercise parameters (secondary outcomes) by enhancing self-management and sustaining diet adherence among the m-Health group using the App versus the control group. Following verification of the intervention's effectiveness, we will analyse its cost-effectiveness.\n\nDesign and subjects: Randomized controlled trial with 212 older people with SO. Interventions: The m-Health group will receive an 8-week supervised nutrition and exercise programme, incorporating the EatWelLog App for dietary management during and after the supervised programme. The control group will receive the same programme without the App.\n\nMain outcome measures and analysis: The primary outcome is SO status evaluated using handgrip strength, muscle mass, body fat mass, and physical performance.\n\nSecondary outcomes include nutritional status, quality of life and exercise adherence. The App intervention's costeffectiveness will be analysed.\n\nExpected results: The m-Health group should demonstrate greater, more sustained improvements in SO and secondary outcomes compared to the control group at Week 8, and at the 3-, 6-, 9-, and 12-month follow-ups. Clinical significance: The EatWelLog App could provide customized support, enhance dietary adherence, and improve long-term outcomes, offering a novel, economical approach to SO management.",[138],"Sacropenic Obesity",[138,140,141,142,143],"m-health","dietary intervention","behaviour change","exercise","NOT_YET_RECRUITING","2026-10-05",{"date":147,"type":148},"2026-10-09","ACTUAL",{"date":150,"type":132},"2026-10-01",{"date":152,"type":132},"2029-09-30",{"name":5,"class":6},1]