Sarcopenic Obesity Clinical Trial
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: - 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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | April 30, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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: 1. 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, 2. 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of muscle strength | Handgrip strength (kg) will be measured by using the hand dynamometer. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Primary | Changes of muscle mass | Muscle mass (kg) will be measured by using bioelectrical impedance analysis. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Primary | Changes of body mass index | The weight and height will be combined to report BMI in kg/m^2. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Primary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Primary | Changes of fat mass | Fat mass (kg) will be measured by using bioelectrical impedance analysis. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Primary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Secondary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Secondary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Secondary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Secondary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Secondary | 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. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program | |
Secondary | Exercise Adherence | Assessed based on the participants' self-reports on their overall adherence to the exercise regimen. | Change from baseline to 8 weeks, 3 months, and 6 months after completing the program |
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