About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community-dwelling older people aged > 50 years;
Sarcopenia refers to the fulfillment both of the following criteria: For participants aged 50-64: low handgrip strength < 34 kg for men and < 20 kg for women, low muscle quality as reflected by low appendicular skeletal muscle mass (ASM) /height squared < 7.6 kg/m2 for men and <5.7 kg/m2 for women. For participants aged 65 or above: handgrip strength <28kg (men) and <18 kg (women); appendicular skeletal muscle mass (ASM)/ height2 <7 kg/m2 (men) and <5.7 kg/m2 (women).
Obesity refers to the fulfillment of one of the following criteria: Body Mass Index (BMI) ≥ 25kg/m2 or waist circumference ≥ 90 cm in men and ≥ 80 cm in women, or percentage of body fat > 30%.
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.
Disqualifiers
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);
Taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication);
With alcohol use disorder as defined by DSM-5, potentially hindering dietary behaviour changes; and
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.
Trial design
Parallel
Treatments tested in this trial
Dietary Modification programme
Behavioral• 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
Exercise Training
BehavioralParticipants 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.
The EatWelLog App
BehavioralParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Muscle Strength
Handgrip strength (kg) will be measured by using a Takei TKK5401 digital hand dynamometer.
Muscle Quantity
Muscle mass (kg) will be measured by using bioelectrical impedance analysis (InBody S10, Korea).
Body Mass Index (BMI)
The weight and height will be combined to report BMI in kg/m\^2.
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-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.
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