Clinical trial
Dietary Programme and Exercise Training in Combination or Separately on Managing Sarcopenic Obesity in Older Adults
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05734755
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
The Individualized Dietary Behavioural Change Programme (IDBC)
The first three weekly face-to-face sessions will be during the 'goal initiation' and 'planning' phases. The remaining seven face-to-face sessions will be offered once to twice per month between weeks 4 and 24 during the program at the 'action execution' phase. Family members will be encouraged to join the dietary consultations. Strategies will be discussed with the family members to facilitate the participant's adherence to the recommended diet regimen.Phase I Goal Initiation is aimed at motivating the participants to actively manage their sarcopenic obesity. Phase II Plan Formulation is aimed at guiding the participants in transforming their (sub-) goals into detailed individualized action plans.Phase III Action Execution is aimed at encouraging the participants to continually execute the action plan. The IDBC guidebook will be given to the participants to guide them on how to gradually adopt our dietary recommendations in their daily life.
The Exercise Training
The group size will be \< 10. They will be used in the resistance exercise in this study to improve muscle strength (20 mins). Brisk walking (20 mins) will be employed in the aerobic exercise in this study. Each session will include 10 minutes of warm-up and cool-down exercises at the beginning and at the end. A YouTube video and a pamphlet describing the different types of exercises used in this programme will be disseminated to all participants to encourage them to continually practise their exercises at home for 30 minutes at least 5 times per week.
Primary outcomes
Handgrip strength (kg) will be measured by using the jamar dynamometer.
Muscle mass (kg) will be measured by using bioelectrical impedance analysis.
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
The weight and height will be combined to report BMI in kg/m\^2.
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.
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Study locations
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