Sarcopenic ObesityNCT06360432
Effects of the EatWelLog App on Diet Management for Older Adults With Sarcopenic Obesity
A study testing Dietary modification program, Exercise training and The EatWellLog App in people with Sarcopenic Obesity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- Dietary modification program, Exercise training and The EatWellLog App
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Apr 2024to 18 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 or above, and living in the community;
- Having SO according to the Asian Working Group for Sarcopenia (AWGS) and the World Health Organization (WHO)'s obesity criteria for Asians:
- Early-stage sarcopenia indicated by fulfilment of one of the following criteria; handgrip strength <28 kg (men) and <18 kg (women); appendicular skeletal muscle mass (ASM)/ height2 <7 kg/m2 (men) and <5.7 kg/m2 (women), or SPPB score of <9; Short Physical Performance Battery (SPPB) score of <9,
- Obesity indicated by BMI ≥25 kg/m2, waist circumference ≥90 cm (men) and ≥80 cm (women), or body fat >30%;
- Own a smartphone with internet access; and
- Proficiency in communicating, reading, and writing in Chinese, and without major hearing and vision impairments to ensure that comprehension of our instructions.
Who cannot join
- Individuals with diseases impacting digestion or food consumption, including severe cardiac/ pulmonary/ renal diseases, diabetes, cancer, or autoimmune disorders;
- Those on medications affecting eating habits, digestion, or metabolism, such as weight loss drugs;
- Persons with alcohol use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), potentially hindering dietary behaviour changes;
- Those with medical implants like pacemakers that could be disrupted by the bioelectric impedance analysis (BIA's) low-level electrical currents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the EatWelLog App on Enhancing Daily Diet Management for Community-dwelling Older Adults With Sarcopenic Obesity: A Pilot Randomized Controlled Trial
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:
Read more
- 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.
Read the detailed description
Sarcopenic obesity (SO), characterized by concurrent reduced muscle mass and excess body fat, affects 11% older adults worldwide, rising to 23% among those over 751. Older adults with reduced muscle mass are 1.95-2.62 times prone to obesity than those with normal muscle mass. This is due to shared etiological factors between sarcopenia and obesity such as sedentary habits and aging-related biological shifts, including decreased anabolic hormones, increased insulin resistance, and escalated oxidative stress. The combination of sarcopenia and obesity has a compounding negative impact on health, raising the likelihood of knee and hip osteoarthritis, which leads to reduced physical capabilities, as well as increasing the risk of cardio-metabolic diseases, institutionalized, and death, exceeding the risks of sarcopenia or obesity alone.
Addressing SO effectively to promote muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies. Currently, exercise and nutrition interventions, are the most commonly recommended interventions.
Exercise and Nutrition Interventions for SO A recent systematic review of 11 trials with 440 SO participants showed that resistance training twice weekly for 20 minutes over a minimum of 8 weeks effectively enhances body composition, muscle strength, and gait speed. Furthermore, evidence suggested that combining aerobic and resistance training with increased protein intake is more effective in reducing body fat than resistance training alone but had no effects on muscle mass and strength. Another systematic review of eight trials with 605 SO participants found that resistance training alone could increase muscle strength. To also improve physical functions (i.e., gait speed and grip strength), exercise combining aerobic and resistance training with dietary supplements seems to have more promising results. The findings in a recent umbrella review of meta-analyses concluded that exercise interventions (either resistance training or combined resistance and aerobic exercise) are beneficial for body composition and physical performance in older adults with SO. However, the added value of exercise with nutrition interventions (either protein supplement and dietary modifications) produces inconsistent results.
Adequate protein intake is vital for muscle building, and calorie restriction is effective at reducing fat mass. Thus, nutrition is a critical factor in the onset and progression of SO, although the evidence for nutrition interventions in reserving SO demonstrated inconsistent effects, especially regarding muscle mass and strength. When implementing a weight loss diet for individuals with SO, it is important to balance fat reduction with muscle mass preservation by ensure adequate protein intake to prevent exacerbating muscle loss. Evidence suggests that the source of protein is crucial for muscle retention, specifically for animal-based proteins, which are high in leucine, may be more effective in preserving muscle mass during weight loss and in maintaining physical function. While nutritional supplements are commonly used to increase protein intake, their effects on SO remain inconsistent and may cause side effects such as digestive issues, interact with certain medications, dehydration, liver and renal damage, bloating, and calcium loss. The investigators advocates for an unhealthy diet incorporating a full spectrum of nutrients from whole foods, in line with the Dietary Guidelines for Americans, 2020-2025, as the preferred approach over supplements for those with sarcopenic obesity. Modifying daily dietary habits of individuals with SO may provide more sustainable benefits than merely adding supplements to their diet.
A recent systematic review examining nutrition interventions in managing sarcopenic obesity analysed nine studies but only two assessed the impact of dietary modifications on protein intake among older adults with SO. The first randomized controlled trial (RCT) assessed the impact of a low-calorie diet with normal (0.8 g/kg body weight/day) versus high protein intake (1.2 g/kg body weight/day) over three months in 104 older women with SO. The study found muscle mass decreased in the normal protein group concurrent with fat loss, while the high protein group saw muscle mass preservation. The second pilot RCT involving 18 women compared a low-calorie diet with placebo to one with high protein (1.2-1.4 g/kg body weight/day) over four months. Significant muscle strength gains were noted in the high protein group, though changes in muscle mass were not significantly different between the two groups. While the findings in these two trials provided preliminary evidence that hypocaloric diet and high protein intake may be necessary for managing SO, particularly for preserving mass muscle and strength. These studies, however, had limitations such as broad inclusion criteria for sarcopenic obesity, lacking a standardized diagnostic protocol, insufficient data on dietary adherence, and opaque details regarding randomization and intervention specifics. More rigorous research is needed to investigate the impact of diet modification on sarcopenic obesity.
Conventional dietary modification intervention that relies on face-to-face consultation and monitoring, faced lots of challenges which included participants' poor compliance to the recommended dietary regimen, high attrition, time constraints and manpower. Those were major threats to the viability of the study leading to inconsistent treatment effects. In addition, the therapeutic effect may gradually reduces after the completion of the dietary training program. Additionally, the therapeutic effect may gradually reduce after the completion of the dietary program.
Rationale for developing a m-health based intervention for SO Systematic reviews found that m-health dietary intervention, with appropriate behaviour change techniques, can achieve dietary behaviour change across a range of chronic illnesses, such as obesity, metabolic syndrome, cardiovascular disease with relatively low attrition rates. To the best of the knowledge, there are no studies evaluating the effects of m-health dietary interventions on SO. The success of m-health interventions in other chronic conditions could potentially be adapted to improve health behaviors in patients with SO.
Aims and Hypotheses to be Tested.
The study aims to evaluate the effects of the EatWellLog App (hereafter referred to as "the App"), designed by the investigators' team to address the needs of 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.
It is hypothesised that the App users will demonstrate significant and sustained improvements in SO status and secondary outcomes immediately after the supervised nutrition and exercise programme and at 3-and 6-month follow ups, compared to the control group who receive the same supervised programme without the App.
The investigators will also explore users' experience with the App by focus groups with all participants in the M-health group, 6-8 per group, to understand their experience of using the App. Additionally, the investigators will analyse the App usage data including session duration, frequency, feature utilisation, and retention rates, at the 3-month and 6-month follow-ups.
- Conditions
- Sarcopenic Obesity
- Being tested
- Dietary modification program, Exercise training, The EatWellLog App
- Keywords
- Sarcopenic Obesity, m-health, dietary intervention, exercise, behaviour change
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary modification programBehavioural
Participants will receive an 8-week program dietary modification program. The dietary modification program is composed of three personalized, one-hour face-to-face sessions and five group-based nutrition classes. Participants will be encouraged to take on a moderate hypocaloric plan that cuts daily energy expenditure to encourage steady weight loss while preserving muscle mass. A protein intake of 1.5 g/kg of body weight per day is recommended. To optimize protein uptake, it's suggested that protein be distributed evenly across meals, aiming for 25-30 g per meal, inclusive of 2.5-2.8 g of leucine. Participants will also receive a guidebook, crafted through the Delphi method, to facilitate the adoption of these dietary modifications in their daily routines.
Exercise trainingBehavioural
Participants will receive an 8-week program consisting of exercise training. It entails weekly group sessions, with each lasting an hour for 8 weeks. These sessions, designed for groups of approximately 10, will blend resistance and aerobic workouts to enhance muscle mass and strength while reducing fat in individuals with SO. Each session includes a 10-minute warm-up and cool-down, 20 minutes of resistance training using elastic bands, followed by a 20-minute brisk walking segment. Participants will also receive a YouTube link and a pamphlet describing the exercises, encouraging them to maintain at least 30 minutes of exercise five times a week during and beyond the supervised programme.
The EatWellLog AppBehavioural
Only participants in the M-health group will be instructed to use the EatWellLog 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, in line with current nutritional recommendations for this demographic. The EatWellLog App has the following features: i) tracking participants' dietary habits by logging meals and snacks from a food list, ii) personalized online coaching and reminders by a multidisciplinary healthcare team, iii) participation of family caregivers through an interactive messaging function, iv) accessing health information via multiple channels, including animations, an at-a-glance display, and a reminder, and v) utilization of game elements, such as educational animations and video games to disseminate health and nutritional information related to SO.
| Study group | Role | What they receive |
|---|---|---|
| M-health group | Experimental | Participants in the M-health will receive an 8-week program consisting of personalized dietary modification program and group-based exercise training. Additionally, the m-health group will be instructed to use the EatWellLog app for daily diet self-management. Receives: Behavioral: Dietary modification program; Behavioral: Exercise training; Behavioral: The EatWellLog App |
| Control group | Sham comparator | Participants in the Control group will receive an identical, 8-week program consisting of personalized dietary modification program and group-based exercise training without using the EatWellLog App. Receives: Behavioral: Dietary modification program; Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of muscle strength
Handgrip strength (kg) will be measured by using the hand dynamometer.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Changes of muscle mass
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Changes of body mass index
The weight and height will be combined to report BMI in kg/m^2.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Changes of waist circumference
Waist circumference was taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Changes of fat mass
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months 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.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Secondary outcomes (6)
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.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months 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.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months 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.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
EuroQoL 5D (EQ-5D)
The EQ-5D comprises five dimensions of health: mobility, self-care, usual activities, pain / discomfort, and anxiety/depression. Each of them has three response categories: no, some, 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.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Diet Adherence
The adherence to protein intake will be analyzed by a software program "Food Processor®". If any participant forgets to keep the dietary record, the 7-day food recall method will be used by the experimental group facilitator to check the participant's food intake, an approach commonly used in nutritional studies.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Exercise Adherence
Assessed based on the participants' self-reports on their overall adherence to the exercise regimen.
Measured: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start8 Apr 2024
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University
- Investigators
- Justina Liu, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360432
- Sponsor's protocol ID
- HSEARS20240214001
- Status last verified
- Jul 2026
- First submitted
- 20 Mar 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 7 years after the completion of this research.
Publications
Gao Q, Mei F, Shang Y, Hu K, Chen F, Zhao L, Ma B. Global prevalence of sarcopenic obesity in older adults: A systematic review and meta-analysis. Clin Nutr. 2021 Jul;40(7):4633-4641. doi: 10.1016/j.clnu.2021.06.009. Epub 2021 Jun 21.
PubMed 34229269Stenholm S, Harris TB, Rantanen T, Visser M, Kritchevsky SB, Ferrucci L. Sarcopenic obesity: definition, cause and consequences. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):693-700. doi: 10.1097/MCO.0b013e328312c37d.
PubMed 18827572Polyzos SA, Margioris AN. Sarcopenic obesity. Hormones (Athens). 2018 Sep;17(3):321-331. doi: 10.1007/s42000-018-0049-x. Epub 2018 Jul 16.
PubMed 30014320Kob R, Bollheimer LC, Bertsch T, Fellner C, Djukic M, Sieber CC, Fischer BE. Sarcopenic obesity: molecular clues to a better understanding of its pathogenesis? Biogerontology. 2015 Feb;16(1):15-29. doi: 10.1007/s10522-014-9539-7. Epub 2014 Nov 7.
PubMed 25376109Nakano R, Takebe N, Ono M, Hangai M, Nakagawa R, Yashiro S, Murai T, Nagasawa K, Takahashi Y, Satoh J, Ishigaki Y. Involvement of oxidative stress in atherosclerosis development in subjects with sarcopenic obesity. Obes Sci Pract. 2017 Jan 27;3(2):212-218. doi: 10.1002/osp4.97. eCollection 2017 Jun.
PubMed 28702214Godziuk K, Prado CM, Woodhouse LJ, Forhan M. The impact of sarcopenic obesity on knee and hip osteoarthritis: a scoping review. BMC Musculoskelet Disord. 2018 Jul 28;19(1):271. doi: 10.1186/s12891-018-2175-7.
PubMed 30055599Nezameddin R, Itani L, Kreidieh D, El Masri D, Tannir H, El Ghoch M. Understanding Sarcopenic Obesity in Terms of Definition and Health Consequences: A Clinical Review. Curr Diabetes Rev. 2020;16(9):957-961. doi: 10.2174/1573399816666200109091449.
PubMed 31916519Alexandre TDS, Scholes S, Ferreira Santos JL, Duarte YAO, de Oliveira C. The combination of dynapenia and abdominal obesity as a risk factor for worse trajectories of IADL disability among older adults. Clin Nutr. 2018 Dec;37(6 Pt A):2045-2053. doi: 10.1016/j.clnu.2017.09.018. Epub 2017 Oct 2.
PubMed 29033231Reiter L, Bauer S, Traxler M, Schoufour JD, Weijs PJM, Cruz-Jentoft A, Topinkova E, Eglseer D. Effects of Nutrition and Exercise Interventions on Persons with Sarcopenic Obesity: An Umbrella Review of Meta-Analyses of Randomised Controlled Trials. Curr Obes Rep. 2023 Sep;12(3):250-263. doi: 10.1007/s13679-023-00509-0. Epub 2023 May 30.
PubMed 37249818Eglseer D, Traxler M, Schoufour JD, Weijs PJM, Voortman T, Boirie Y, Cruz-Jentoft AJ, Reiter L, Bauer S; SO-NUTS Consortium. Nutritional and exercise interventions in individuals with sarcopenic obesity around retirement age: a systematic review and meta-analysis. Nutr Rev. 2023 Aug 10;81(9):1077-1090. doi: 10.1093/nutrit/nuad007.
PubMed 36882046Hita-Contreras F, Bueno-Notivol J, Martinez-Amat A, Cruz-Diaz D, Hernandez AV, Perez-Lopez FR. Effect of exercise alone or combined with dietary supplements on anthropometric and physical performance measures in community-dwelling elderly people with sarcopenic obesity: A meta-analysis of randomized controlled trials. Maturitas. 2018 Oct;116:24-35. doi: 10.1016/j.maturitas.2018.07.007. Epub 2018 Jul 19.
PubMed 30244776Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. Aging is associated with diminished accretion of muscle proteins after the ingestion of a small bolus of essential amino acids. Am J Clin Nutr. 2005 Nov;82(5):1065-73. doi: 10.1093/ajcn/82.5.1065.
PubMed 16280440Mathus-Vliegen EM; Obesity Management Task Force of the European Association for the Study of Obesity. Prevalence, pathophysiology, health consequences and treatment options of obesity in the elderly: a guideline. Obes Facts. 2012;5(3):460-83. doi: 10.1159/000341193. Epub 2012 Jun 30.
PubMed 22797374Abiri B, Hosseinpanah F, Seifi Z, Amini S, Valizadeh M. The Implication of Nutrition on the Prevention and Improvement of Age-Related Sarcopenic Obesity: A Systematic Review. J Nutr Health Aging. 2023;27(10):842-852. doi: 10.1007/s12603-023-1986-x.
PubMed 37960907Trouwborst 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.
PubMed 29757230
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the EatWelLog App on Enhancing Daily Diet Management for Community-dwelling Older Adults With Sarcopenic Obesity: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06360432
- Acronym / sponsor ID
- HSEARS20240214001
- Conditions
- Sarcopenic Obesity
- Keywords
- Sarcopenic Obesity, m-health, dietary intervention, exercise, behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sarcopenic obesity (SO), characterized by concurrent reduced muscle mass and excess body fat, affects 11% older adults worldwide, rising to 23% among those over 751. Older adults with reduced muscle mass are 1.95-2.62 times prone to obesity than those with normal muscle mass. This is due to shared etiological factors between sarcopenia and obesity such as sedentary habits and aging-related biological shifts, including decreased anabolic hormones, increased insulin resistance, and escalated oxidative stress. The combination of sarcopenia and obesity has a compounding negative impact on health, raising the likelihood of knee and hip osteoarthritis, which leads to reduced physical capabilities, as well as increasing the risk of cardio-metabolic diseases, institutionalized, and death, exceeding the risks of sarcopenia or obesity alone.
Addressing SO effectively to promote muscle mass gains while reducing fat mass remains a significant challenge, necessitating urgent and effective intervention strategies. Currently, exercise and nutrition interventions, are the most commonly recommended interventions.
Exercise and Nutrition Interventions for SO A recent systematic review of 11 trials with 440 SO participants showed that resistance training twice weekly for 20 minutes over a minimum of 8 weeks effectively enhances body composition, muscle strength, and gait speed. Furthermore, evidence suggested that combining aerobic and resistance training with increased protein intake is more effective in reducing body fat than resistance training alone but had no effects on muscle mass and strength. Another systematic review of eight trials with 605 SO participants found that resistance training alone could increase muscle strength. To also improve physical functions (i.e., gait speed and grip strength), exercise combining aerobic and resistance training with dietary supplements seems to have more promising results. The findings in a recent umbrella review of meta-analyses concluded that exercise interventions (either resistance training or combined resistance and aerobic exercise) are beneficial for body composition and physical performance in older adults with SO. However, the added value of exercise with nutrition interventions (either protein supplement and dietary modifications) produces inconsistent results.
Adequate protein intake is vital for muscle building, and calorie restriction is effective at reducing fat mass. Thus, nutrition is a critical factor in the onset and progression of SO, although the evidence for nutrition interventions in reserving SO demonstrated inconsistent effects, especially regarding muscle mass and strength. When implementing a weight loss diet for individuals with SO, it is important to balance fat reduction with muscle mass preservation by ensure adequate protein intake to prevent exacerbating muscle loss. Evidence suggests that the source of protein is crucial for muscle retention, specifically for animal-based proteins, which are high in leucine, may be more effective in preserving muscle mass during weight loss and in maintaining physical function. While nutritional supplements are commonly used to increase protein intake, their effects on SO remain inconsistent and may cause side effects such as digestive issues, interact with certain medications, dehydration, liver and renal damage, bloating, and calcium loss. The investigators advocates for an unhealthy diet incorporating a full spectrum of nutrients from whole foods, in line with the Dietary Guidelines for Americans, 2020-2025, as the preferred approach over supplements for those with sarcopenic obesity. Modifying daily dietary habits of individuals with SO may provide more sustainable benefits than merely adding supplements to their diet.
A recent systematic review examining nutrition interventions in managing sarcopenic obesity analysed nine studies but only two assessed the impact of dietary modifications on protein intake among older adults with SO. The first randomized controlled trial (RCT) assessed the impact of a low-calorie diet with normal (0.8 g/kg body weight/day) versus high protein intake (1.2 g/kg body weight/day) over three months in 104 older women with SO. The study found muscle mass decreased in the normal protein group concurrent with fat loss, while the high protein group saw muscle mass preservation. The second pilot RCT involving 18 women compared a low-calorie diet with placebo to one with high protein (1.2-1.4 g/kg body weight/day) over four months. Significant muscle strength gains were noted in the high protein group, though changes in muscle mass were not significantly different between the two groups. While the findings in these two trials provided preliminary evidence that hypocaloric diet and high protein intake may be necessary for managing SO, particularly for preserving mass muscle and strength. These studies, however, had limitations such as broad inclusion criteria for sarcopenic obesity, lacking a standardized diagnostic protocol, insufficient data on dietary adherence, and opaque details regarding randomization and intervention specifics. More rigorous research is needed to investigate the impact of diet modification on sarcopenic obesity.
Conventional dietary modification intervention that relies on face-to-face consultation and monitoring, faced lots of challenges which included participants' poor compliance to the recommended dietary regimen, high attrition, time constraints and manpower. Those were major threats to the viability of the study leading to inconsistent treatment effects. In addition, the therapeutic effect may gradually reduces after the completion of the dietary training program. Additionally, the therapeutic effect may gradually reduce after the completion of the dietary program.
Rationale for developing a m-health based intervention for SO Systematic reviews found that m-health dietary intervention, with appropriate behaviour change techniques, can achieve dietary behaviour change across a range of chronic illnesses, such as obesity, metabolic syndrome, cardiovascular disease with relatively low attrition rates. To the best of the knowledge, there are no studies evaluating the effects of m-health dietary interventions on SO. The success of m-health interventions in other chronic conditions could potentially be adapted to improve health behaviors in patients with SO.
Aims and Hypotheses to be Tested.
The study aims to evaluate the effects of the EatWellLog App (hereafter referred to as "the App"), designed by the investigators' team to address the needs of 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.
It is hypothesised that the App users will demonstrate significant and sustained improvements in SO status and secondary outcomes immediately after the supervised nutrition and exercise programme and at 3-and 6-month follow ups, compared to the control group who receive the same supervised programme without the App.
The investigators will also explore users' experience with the App by focus groups with all participants in the M-health group, 6-8 per group, to understand their experience of using the App. Additionally, the investigators will analyse the App usage data including session duration, frequency, feature utilisation, and retention rates, at the 3-month and 6-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| M-health group | Experimental | Behavioral: Dietary modification program, Behavioral: Exercise training, Behavioral: The EatWellLog AppParticipants in the M-health will receive an 8-week program consisting of personalized dietary modification program and group-based exercise training. Additionally, the m-health group will be instructed to use the EatWellLog app for daily diet self-management. |
| Control group | Sham comparator | Behavioral: Dietary modification program, Behavioral: Exercise trainingParticipants in the Control group will receive an identical, 8-week program consisting of personalized dietary modification program and group-based exercise training without using the EatWellLog App. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged 65 or above, and living in the community;
- Having SO according to the Asian Working Group for Sarcopenia (AWGS) and the World Health Organization (WHO)'s obesity criteria for Asians:
- Own a smartphone with internet access; and
- Proficiency in communicating, reading, and writing in Chinese, and without major hearing and vision impairments to ensure that comprehension of our instructions.
Key exclusion criteria (4 listed)
- Individuals with diseases impacting digestion or food consumption, including severe cardiac/ pulmonary/ renal diseases, diabetes, cancer, or autoimmune disorders;
- Those on medications affecting eating habits, digestion, or metabolism, such as weight loss drugs;
- Persons with alcohol use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), potentially hindering dietary behaviour changes;
- Those with medical implants like pacemakers that could be disrupted by the bioelectric impedance analysis (BIA's) low-level electrical currents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary modification programParticipants will receive an 8-week program dietary modification program. The dietary modification program is composed of three personalized, one-hour face-to-face sessions and five group-based nutrition classes. Participants will be encouraged to take on a moderate hypocaloric plan that cuts daily energy expenditure to encourage steady weight loss while preserving muscle mass. A protein intake of 1.5 g/kg of body weight per day is recommended. To optimize protein uptake, it's suggested that protein be distributed evenly across meals, aiming for 25-30 g per meal, inclusive of 2.5-2.8 g of leucine. Participants will also receive a guidebook, crafted through the Delphi method, to facilitate the adoption of these dietary modifications in their daily routines. | Behavioural | Control group, M-health group |
| Exercise trainingParticipants will receive an 8-week program consisting of exercise training. It entails weekly group sessions, with each lasting an hour for 8 weeks. These sessions, designed for groups of approximately 10, will blend resistance and aerobic workouts to enhance muscle mass and strength while reducing fat in individuals with SO. Each session includes a 10-minute warm-up and cool-down, 20 minutes of resistance training using elastic bands, followed by a 20-minute brisk walking segment. Participants will also receive a YouTube link and a pamphlet describing the exercises, encouraging them to maintain at least 30 minutes of exercise five times a week during and beyond the supervised programme. | Behavioural | Control group, M-health group |
| The EatWellLog AppOnly participants in the M-health group will be instructed to use the EatWellLog 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, in line with current nutritional recommendations for this demographic. The EatWellLog App has the following features: i) tracking participants' dietary habits by logging meals and snacks from a food list, ii) personalized online coaching and reminders by a multidisciplinary healthcare team, iii) participation of family caregivers through an interactive messaging function, iv) accessing health information via multiple channels, including animations, an at-a-glance display, and a reminder, and v) utilization of game elements, such as educational animations and video games to disseminate health and nutritional information related to SO. | Behavioural | M-health group |
Primary outcome
Changes of muscle strength
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Handgrip strength (kg) will be measured by using the hand dynamometer.
Changes of muscle mass
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of body mass index
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
The weight and height will be combined to report BMI in kg/m^2.
Changes of waist circumference
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Waist circumference was taken as the minimum circumference between the umbilicus and xiphoid process and measured to the nearest 0.5 cm.
Changes of fat mass
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
The Short Physical Performance Battery (SPPB) scale
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
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.
6 secondary outcomes
Mini Nutritional Assessment (MNA) Short-form
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Health Action Process Approach (HAPA) Nutrition Self-efficacy Scale
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Dietary Quality Index-International (DQI-I)
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
EuroQoL 5D (EQ-5D)
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Diet Adherence
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Exercise Adherence
Time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 34229269Gao Q, Mei F, Shang Y, Hu K, Chen F, Zhao L, Ma B. Global prevalence of sarcopenic obesity in older adults: A systematic review and meta-analysis. Clin Nutr. 2021 Jul;40(7):4633-4641. doi: 10.1016/j.clnu.2021.06.009. Epub 2021 Jun 21.
- Background: PubMed 18827572Stenholm S, Harris TB, Rantanen T, Visser M, Kritchevsky SB, Ferrucci L. Sarcopenic obesity: definition, cause and consequences. Curr Opin Clin Nutr Metab Care. 2008 Nov;11(6):693-700. doi: 10.1097/MCO.0b013e328312c37d.
- Background: PubMed 30014320Polyzos SA, Margioris AN. Sarcopenic obesity. Hormones (Athens). 2018 Sep;17(3):321-331. doi: 10.1007/s42000-018-0049-x. Epub 2018 Jul 16.
- Background: PubMed 25376109Kob R, Bollheimer LC, Bertsch T, Fellner C, Djukic M, Sieber CC, Fischer BE. Sarcopenic obesity: molecular clues to a better understanding of its pathogenesis? Biogerontology. 2015 Feb;16(1):15-29. doi: 10.1007/s10522-014-9539-7. Epub 2014 Nov 7.
- Background: PubMed 28702214Nakano R, Takebe N, Ono M, Hangai M, Nakagawa R, Yashiro S, Murai T, Nagasawa K, Takahashi Y, Satoh J, Ishigaki Y. Involvement of oxidative stress in atherosclerosis development in subjects with sarcopenic obesity. Obes Sci Pract. 2017 Jan 27;3(2):212-218. doi: 10.1002/osp4.97. eCollection 2017 Jun.
- Background: PubMed 30055599Godziuk K, Prado CM, Woodhouse LJ, Forhan M. The impact of sarcopenic obesity on knee and hip osteoarthritis: a scoping review. BMC Musculoskelet Disord. 2018 Jul 28;19(1):271. doi: 10.1186/s12891-018-2175-7.
- Background: PubMed 31916519Nezameddin R, Itani L, Kreidieh D, El Masri D, Tannir H, El Ghoch M. Understanding Sarcopenic Obesity in Terms of Definition and Health Consequences: A Clinical Review. Curr Diabetes Rev. 2020;16(9):957-961. doi: 10.2174/1573399816666200109091449.
- Background: PubMed 29033231Alexandre TDS, Scholes S, Ferreira Santos JL, Duarte YAO, de Oliveira C. The combination of dynapenia and abdominal obesity as a risk factor for worse trajectories of IADL disability among older adults. Clin Nutr. 2018 Dec;37(6 Pt A):2045-2053. doi: 10.1016/j.clnu.2017.09.018. Epub 2017 Oct 2.
- Background: PubMed 37249818Reiter L, Bauer S, Traxler M, Schoufour JD, Weijs PJM, Cruz-Jentoft A, Topinkova E, Eglseer D. Effects of Nutrition and Exercise Interventions on Persons with Sarcopenic Obesity: An Umbrella Review of Meta-Analyses of Randomised Controlled Trials. Curr Obes Rep. 2023 Sep;12(3):250-263. doi: 10.1007/s13679-023-00509-0. Epub 2023 May 30.
- Background: PubMed 36882046Eglseer D, Traxler M, Schoufour JD, Weijs PJM, Voortman T, Boirie Y, Cruz-Jentoft AJ, Reiter L, Bauer S; SO-NUTS Consortium. Nutritional and exercise interventions in individuals with sarcopenic obesity around retirement age: a systematic review and meta-analysis. Nutr Rev. 2023 Aug 10;81(9):1077-1090. doi: 10.1093/nutrit/nuad007.
- Background: PubMed 30244776Hita-Contreras F, Bueno-Notivol J, Martinez-Amat A, Cruz-Diaz D, Hernandez AV, Perez-Lopez FR. Effect of exercise alone or combined with dietary supplements on anthropometric and physical performance measures in community-dwelling elderly people with sarcopenic obesity: A meta-analysis of randomized controlled trials. Maturitas. 2018 Oct;116:24-35. doi: 10.1016/j.maturitas.2018.07.007. Epub 2018 Jul 19.
- Background: PubMed 16280440Katsanos CS, Kobayashi H, Sheffield-Moore M, Aarsland A, Wolfe RR. Aging is associated with diminished accretion of muscle proteins after the ingestion of a small bolus of essential amino acids. Am J Clin Nutr. 2005 Nov;82(5):1065-73. doi: 10.1093/ajcn/82.5.1065.
- Individual participant dataSharing planned: No. For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 7 years after the completion of this research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justina Liu, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary modification program, Exercise training and The EatWellLog App in people with Sarcopenic Obesity, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of muscle strength (time frame: Change from baseline to 8 weeks, 3 months, and 6 months after completing the program). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360432, which also lists 52 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.