Dietary Programme and Exercise Training in Combination or Separately on Managing Sarcopenic Obesity in Older Adults

NCT05734755 | Active Not Recruiting DMC

• 1 other identifier: HSEARS20220722001
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenic Obesity

Keywords

Sarcopenic Obesity; Dietary intervention; Behavioural Change; Lifestyle intervention; RCT

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Mini Nutritional Assessment (MNA) Short-form

  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

• Diet Adherence

  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

• Exercise Adherence

  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

• Health action process approach(HAPA)Nutrition Self-efficacy Scale

  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

• Dietary quality index-International (DQI-I)

  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

Study Arms (4)

The COMB group

EXPERIMENTAL

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.

Behavioral: The Individualized Dietary Behavioural Change Programme (IDBC); Behavioral: The Exercise Training

The EXER-only group

EXPERIMENTAL

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.

Behavioral: The Exercise Training

The IDBC-only group

EXPERIMENTAL

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.

Behavioral: The Individualized Dietary Behavioural Change Programme (IDBC)

The Control Group

NO INTERVENTION

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.

Interventions

The Individualized Dietary Behavioural Change Programme (IDBC) BEHAVIORAL

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 COMB group; The IDBC-only group

The Exercise Training BEHAVIORAL

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.

The COMB group; The EXER-only group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication);
• being addicted to alcohol, which might affect the effort to change dietary behaviour;
• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

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Related Links

• Dietary Guidelines for Americans, 2020-2025
• The Asia-Pacific perspective: redefining obesity and its treatment
• Centre for Health Protection Hong Kong. Obesity: A Weighty Health Issue Key Messages
• Research E. Food Processor® software

Study Officials

• Justina Liu, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor who is blinded to the group allocations will assess the participants' outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A four-arm Cluster RCT to evaluate the effects of an individualized dietary behavioural change (IDBC) programme and exercise training, in combination (COMB group) and separately (EXER-only and IDBC-only groups), to counteract sarcopenic obesity when compared with a control group receiving only health talks.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: March 15, 2023
• Primary Completion: May 29, 2026
• Study Completion: June 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)