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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• community-dwelling older people aged \> 65 years

• 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%;

• able to communicate, read, and write in Chinese without significant hearing and vision problems to ensure that our instructions are understood.

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Justina Liu, PhD
justina.liu@polyu.edu.hk
27666427
Backup
Jackie Yeung, BA
jackie.yeung@polyu.edu.hk
27666427
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 380
Treatments
Experimental: The COMB group
Participants in The COMB group will be grounded on the HAPA model and piloted by the team. It consists of three phases with 10 face-to-face hourly sessions nested with weekly telephone calls to enhance the participants' adherence to dietary behavioral change. And will be group-based, and offered weekly for about 60 minutes during the execution phase (a total 20 sessions from weeks 4-24). The combination of resistance and aerobic exercises can improve muscle quantity and strength as well as reduce body fat in people with sarcopenic obesity, and will be adopted in this study.
Experimental: The EXER-only group
Participants in The EXER-only group will be group-based, and offered weekly for about 60 minutes during the execution phase (a total 20 sessions from weeks 4-24). The combination of resistance and aerobic exercises can improve muscle quantity and strength as well as reduce body fat in people with sarcopenic obesity, and will be adopted in this study.
Experimental: The IDBC-only group
Participants in The IDBC-only group will be grounded on the HAPA model and piloted by the team. It consists of three phases with 10 face-to-face hourly sessions nested with weekly telephone calls to enhance the participants' adherence to dietary behavioral change. And attend centre-based health talks about the management of different health issues with the exception of sarcopenic obesity.
No_intervention: The Control Group
Participants in The Control Group will attend centre-based health talks about the management of different health issues with the exception of sarcopenic obesity. As the purpose of the health talk is to control the group interactive effect in exercise training, the group size, and the frequency and the time of the health talks will be similar to those offered in the exercise programme for the COMB and EXER-only groups.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov