An interventional study of Dietary Modification programme and Exercise Training in Sacropenic Obesity, sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
Background: Sarcopenic obesity (SO) affects 10% of older adults increased to 23% of those 75+, raising health risks and health cost.
Objectives: 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.
Design 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.
Main outcome measures and analysis: The primary outcome is SO status evaluated using handgrip strength, muscle mass, body fat mass, and physical performance.
Secondary outcomes include nutritional status, quality of life and exercise adherence. The App intervention's costeffectiveness will be analysed.
Expected 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.
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.
Mobile 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.
Currently, 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.
Study 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.
Hypotheses: 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.
Study Design \& Methodology Study Design: The study will adopt a two-arm, assessor-blinded, parallel-group randomized controlled trial design.
Participants:
Sample size: 212 (106 per group) community-dwelling older people with SO
Inclusion criteria:
Having SO according to the Asian Working Group for Sarcopenia (AWGS)9 and the WHO's obesity criteria for Asians9:
Exclusion criteria: Individuals who:
Focus 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.
Interventions:
Both 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.
The 8-week Intervention components for both the m-Health and control groups:
Intervention components for the m-Health group:
The control condition:
2,646 studies on the registry are indexed under Motor Activity; 1,205 are open to participants now.
This study's planned enrollment of 212 is above the median of 60 across 2,309 interventional studies indexed under Motor Activity.
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Exclusion Criteria:
M-Health group will receive an 8-week supervised nutrition and exercise programme, and training to incorporate the EatWelLog App for daily dietary management.
Behavioral: Dietary Modification programme · Behavioral: Exercise Training · Behavioral: The EatWelLog App
Control group will receive the identical 8-week supervised programme without using the EatWelLog App.
Behavioral: Dietary Modification programme · Behavioral: Exercise Training
• 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) * 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/kg of body weight per day is recommended, with leucine-rich animal proteins prioritized to enhance muscle development9
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.
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.
Muscle Strength
Handgrip strength (kg) will be measured by using a Takei TKK5401 digital hand dynamometer.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program
Muscle Quantity
Muscle mass (kg) will be measured by using bioelectrical impedance analysis (InBody S10, Korea).
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
Body Mass Index (BMI)
The weight and height will be combined to report BMI in kg/m\^2.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
Waist Circumference
Waist circumference was taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
Fat Mass
Fat mass (kg) will be measured by using bioelectrical impedance analysis (S10, Korea).
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
EuroQoL 5D-5L (EQ-5D-5L)
The EQ-5D-5L comprises five dimensions of health: mobility, self-care, usual activities, pain / discomfort, and anxiety/depression. 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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
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.
Time frame: From baseline (T0) to 8 weeks (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (T5) after completing the program.
Plan to share: No — For confidentiality, The research team will collect and use only the minimum amount of personal data necessary. All personal data will be handled in accordance with the Personal Data (Privacy) Ordinance of Hong Kong. Each participant will be assigned a unique study identification code, and no identifying information will appear in any reports or publications. All research records will be stored securely in password protected electronic systems and/or locked cabinets, accessible only to authorized research personnel.
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