About this 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:
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 65 or above, and living in the community;
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Dietary modification program
BehavioralParticipants will receive an 8-week program consisting of personalized dietary modification program. The dietary modification program is composed of a total of 8 personalized, one-hour face-to-face sessions. 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 training
BehavioralParticipants 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 App
BehavioralOnly 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.
Treatment groups
Trial outcomes
Primary outcomes
Changes of muscle strength
Handgrip strength (kg) will be measured by using the hand dynamometer.
Changes of muscle mass
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of body mass index
The weight and height will be combined to report BMI in kg/m\^2.
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.
Secondary outcomes
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.
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.
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.
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.
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