protocolSection identificationModule nctId: NCT06360432, orgStudyIdInfo id: HSEARS20240214001, briefTitle: Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: Sarcopenic obesity, characterised by concurrent reduced muscle mass and excess body fat, affects 11% of older adults worldwide, rising to 23% in those over 75. Considering the negative synergistic impact on health, promoting muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies for managing SO. Exercise and nutrition are the primary interventions recommended for SO.This project aims to evaluate the effects of the EatWellLog App developed by the investigators' team for local older adults, in improving:* their sarcopenic obesity status, measured by all four diagnostic criteria, including grip strength, muscle mass, physical performance and body fat mass (primary outcome), and,* nutritional self-efficacy, nutritional status, dietary quality, health-related quality of life, and adherence to diet and exercise regimens (secondary outcomes), by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group.The EatWellLog App, designed for older adults with SO, incorporating Klasnja and Pratt's five-strategy framework for mobile health (mHealth) applications development to facilitate health behavioural change. This App supports users with SO in managing daily diets that promote gradual weight loss and muscle mass preservation, adhering to the dietary regimen for this population.Forty older adults with SO will be recruited from local community health centres and then randomized to either m-health or control groups. Both groups will receive an 8-week supervised programme separately. The programme consists of personalised dietary modification programme and group-based exercise training which have been tested and used in the investigators' pilot and General Research Fund (GRF) project. Additionally, only the m-health group will be instructed to use the App for daily diet self-management.Participants will be assessed on a variety of outcomes immediately after the 8-week supervised programme (T1), which will be compared to the baseline (T0). To explore the possible long-term effects of the intervention, other measurements will be conducted at 3-(T2) and 6-(T3) months after the supervised programme, which will be compared with those conducted at T0., conditionsModule conditions: Sarcopenic Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-arm, assessor-blinded, parallel design pilot randomized control trial (RCT) consisting of a M-health and a control group will be adopted to evaluate the effectiveness of the EatWellLog App in improving older adults' sarcopenic obesity (SO) status and other SO-related parameters by enhancing the self-management abilities and longer-term adherence to daily diet management among participants in the M-health group using the App, compared to the control group., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: An independent assessor who is blinded to the group allocations will assess the participants' outcomes., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dietary modification program, interventions name: Exercise training, interventions name: The EatWellLog App, outcomesModule primaryOutcomes measure: Changes of muscle strength, primaryOutcomes measure: Changes of muscle mass, primaryOutcomes measure: Changes of body mass index, primaryOutcomes measure: Changes of waist circumference, primaryOutcomes measure: Changes of fat mass, primaryOutcomes measure: The Short Physical Performance Battery (SPPB) scale, secondaryOutcomes measure: Mini Nutritional Assessment (MNA) Short-form, secondaryOutcomes measure: Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale, secondaryOutcomes measure: Dietary Quality Index-International (DQI-I), secondaryOutcomes measure: EuroQoL 5D (EQ-5D), secondaryOutcomes measure: Diet Adherence, secondaryOutcomes measure: Exercise Adherence, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Hong Kong, country: Hong Kong, contacts name: Amy Cheung, MA, role: CONTACT, phone: +852 27664145, email: amy-ka-po.cheung@polyu.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False