Sarcopenic Obesity Clinical Trial
Official title:
Effects of an Individualized Dietary Behavioural Change (IDBC) Programme and Exercise Training in Combination or Separately on Managing Sarcopenic Obesity in Community-dwelling Older Adults: A Randomized Controlled Trial
Sarcopenic obesity (SO) has synergistic detrimental effects on elderlies' health. It greatly increases the risk of cardio-metabolic diseases, physical impairment, institutionalization, and mortality when compared with sarcopenia or obesity alone. Effective interventions to simultaneously increase muscle mass and decrease fat mass are challenging but highly warranted. Research showed that exercise tends to produce better outcomes in SO than nutritional interventions. Inconsistent effects of nutritional interventions may be due to a short intervention duration and participants' poor compliance with nutritional advice. Participants' adherence to a dietary regimen is essential to the success of nutritional interventions. Behavior change techniques grounded in a tested effective theoretical model - the Health Action Process Approach [HAPA] model at improving participants' self-efficacy should be incorporated in a diet modification intervention.This project aims to investigate the effects of a HAPA-based individualized dietary behavior change (IDBC) intervention and exercise training, in combination and separately, for elderly with SO, to improve their body composition and physical functions. In this four-armed randomized controlled trial, investigators will recruit and randomize 380 elderly with SO to one of the following four groups: the combined (COMB) group, receiving the 24-week combined intervention consisting of the IDBC program and exercise training, the EXER-only group, receiving only the exercise training, the IDBC-only group, receiving a combination of the IDBC program and health talks, and the control group, receiving only health talks with no other intervention. Investigators will use health talks to control the group and social interaction effects of the group exercise training for the COMB and the EXER-only groups. Investigators hypothesize that participants in the COMB, EXER-only, and IDBC-only groups will have significantly better outcome measures middle of the intervention (T1), immediately (T2), at 3-months (T3), and 6-months (T4) post-intervention than those in the control group when compared to baseline (T0). Investigators will use mixed-effects modeling to compare changes in all outcome variables at the three post-tests among the four groups. If our intervention is effective at mitigating or preventing such occurrences, the impact on public health will be significant. A similar intervention for other populations.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | March 15, 2026 |
Est. primary completion date | September 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. community-dwelling older people aged > 65 years 2. who meet the diagnostic criteria of sarcopenic obesity according to the Asian Sarcopenia Working Group (ASWG)41 and the WHO definition of obesity for the Asian population, respectively: 2a) Early stage sarcopenia refers to the fulfillment of one of the following criteria: low handgrip strength < 28 kg for men and < 18 kg for women, low muscle quality as reflected by low appendicular skeletal muscle mass (ASM) /height squared < 7 kg/m2 for men and <5.7 kg/m2 for women, or low physical performance with a Short Physical Performance Battery (SPPB) score of < 9; 2b) Obesity refers to the fulfillment of one of the following criteria: BMI = 23kg/m2 or waist circumference = 90 cm in men and = 80 cm in women, or percentage of body fat > 30%; 3. able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure that our instructions are understood. Exclusion Criteria: 1. those 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); 2. taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication); 3. being addicted to alcohol, which might affect the effort to change dietary behaviour; 4. having impaired mobility, which might affect participation in exercise training, as defined by a modified Functional Ambulatory Classification score of < 7; ) 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. |
Country | Name | City | State |
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Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
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The Hong Kong Polytechnic University |
Hong Kong,
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* Note: There are 54 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of muscle strength | Handgrip strength (kg) will be measured by using the jamar dynamometer. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
Primary | Changes of muscle mass | Muscle mass (kg) will be measured by using bioelectrical impedance analysis. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
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 unabbreviated scale title: The Short Physical Performance Battery (SPPB) scale The minimum and maximum values: 0, 10 Higher scores mean a better performance |
Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
Primary | Changes of body mass index | The weight and height will be combined to report BMI in kg/m^2. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
Primary | Waist circumference | To estimate your potential disease risk is to measure your waist circumference. Excessive abdominal fat may be serious because it places you at greater risk for developing obesity-related conditions, such as Type 2 Diabetes, high blood pressure, and coronary artery disease. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
Primary | Changes of fat mass | Fat mass (kg) will be measured by using bioelectrical impedance analysis. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
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 unabbreviated scale title: Mini Nutritional Assessment (MNA) Short-form The minimum and maximum values: 0, 14 Higher scores mean a better nutritional status |
Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
Secondary | Diet Adherence | The adherence to protein intake will be reflected by the protein score in the DQI-I. Total calorie intake will be analyzed by a software program "Food Processor®". If any participant forgets to keep the dietary record, the 3-day food recall method will be used by the IDBC facilitator to check the participant's food intake, an approach commonly used in nutritional studies. The participants' attendance rate in the consultation sessions will be monitored. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
Secondary | Exercise Adherence | Assessed based on the participants' attendance in the weekly exercise training session, as well as on their self-reports on their overall adherence to the exercise regimen. | Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
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 which was developed by Ralf Schwarzer and Britta Renner. 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 unabbreviated scale title: Health action process approach(HAPA)Nutrition Self-efficacy Scale The minimum and maximum values: 0, 20 Higher scores mean a higher self-efficacy |
Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme | |
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 unabbreviated scale title: The Dietary quality index-International (DQI-I) The minimum and maximum values: 0, 100 Higher scores mean a better diet quality |
Change from baseline to 12 weeks in the middle of the intervention, 24 weeks after the intervention, 3 months and 6 months after the programme |
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