Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity

NCT04690985 | Completed

• 1 other identifier: HSEARS20191007001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility and preliminary effects of dietary behavior change intervention on the management of sarcopenic obesity (SO) among older people in the community. The feasibility and preliminary effects of the intervention will be tested using a two-armed pilot randomized controlled trial among older people (N=60) with SO in the community in Nanjing, China. Finally, 10 participants will be invited to join a semi-structured interview to explore their perceptions about the whole intervention process. It is hypothesized that the experimental group will have a greater improvement in the body composition, muscle strength and physical function compared to the control group after receiving the 15-week dietary behavior change intervention.

Conditions

Sarcopenic Obesity

Keywords

dietary behaviour change; sarcopenic obesity; community; randomized controlled trial

Outcome Measures

Primary Outcomes (13)

• Changes of muscle strength

  Handgrip strength (kg) will be measured by using the jamar dynamometer.

  Change from baseline to 1 week after the programme

• Changes of physical function

  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).

  Change from baseline to 1 week after the programme

• Changes of skeletal muscle mass

  Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.

  Change from baseline to 1 week after the programme

• Changes of body weight

  Body weight (kg) will be measured.

  Change from baseline to 1 week after the programme

• Changes of fat mass

  Fat mass (kg) will be measured by using bioelectrical impedance analysis.

  Change from baseline to 1 week after the programme

• Changes of visceral fat score

  Visceral fat score will be measured by using bioelectrical impedance analysis. Maintain a visceral fat score below 10 means good health.

  Change from baseline to 1 week 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 1 week after the programme

• Changes of percentage of body fat

  Percentage of body fat will be reported by the percent of body fat mass in whole body weight.

  Change from baseline to 1 week after the programme

• Changes of waist-to-hip ratio

  Waist circumference(cm) and hip circumference (cm) will be measured to report the waist-to-hip ratio.

  Change from baseline to 1 week after the programme

• Recruitment rate

  The proportion of participants who consent to join the study over the eligible participants.

  Baseline

• Attrition rate

  The percentage of participants who withdraw from the study and their reasons for withdrawing.

  At the end of the 15-week programme

• Adherence to diet regimen

  Diet adherence will be assessed by the session attendance (Rate of attendance in 6 sessions).

  Throughout the 15-week programme

• Occurrence of adverse events

  Any adverse events at home will be recorded.

  Throughout the 15-week programme

Secondary Outcomes (5)

• Mini Nutritional Assessment (MNA) Short-form

  Change from baseline to 1 week after the programme

• Nutrition Self-efficacy Scale

  Change from baseline to 1 week after the programme

• Dietary quality index-International

  Change from baseline to 1 week after the programme

• Short Form Health Survey (SF-36)

  Change from baseline to 1 week after the programme

• International Physical Activity Questionnaire Short-form (IPAQ-SF)

  Change from baseline to 1 week after the programme

Study Arms (2)

Control group

SHAM COMPARATOR

The control group will be asked to continue their own daily routes. One research assistant, who will not be involved in other procedures of the study, will contact with the participants to talk about different issues except the SO related topic. The frequency of face-to-face meetings and telephone calls will be similar to the experimental group. The issues talked in the control group could be as follows but not limited: a) normal social communication topics such as greetings, recent living conditions, news in the past week; b) health consultations asked by the participants; c) avoid to mention dietary or exercise related information. An appointment of post-test will be made in the last time telephone call.

Other: Social contact

Experimental group

EXPERIMENTAL

The experimental group will be required to adhere to a diet consisting of a 12% reduction in calorie and a 1.2-1.5 g/kg body weight/day intake of protein. The participants will receive 6 times face-to-face meetings (on week 1, 2, 3, 4, 8 and 12) and weekly telephone call. Each face-to-face meetings will last for around 1 hour, during which the reseacher will help to establish the participants' intention for dietary behavior change, then help transform the intention into detailed plan, and help monitor the execution of the plan continuously.

Behavioral: Dietary behaviour change

Interventions

Dietary behaviour change BEHAVIORAL

The intervention consists of dietary guidance and behaviour change techniques, which will last for 15 weeks. The experimental group will be required to adhere to a diet consisting of a 12% reduction in calorie and a 1.2-1.5 g/kg body weight/day intake of protein. The participants will receive the dietary behaviour change guidance in 6 times face-to-face meetings and weekly telephone calls. They will also be asked to take daily food diary.

Experimental group

Social contact OTHER

The control group will not be required any dietary changes. The investigator will contact with the control group with the same frequency and numbers of experimental group. But the chat topic will not be related to sarcopenic obesity or dietary guidance.

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• community-dwelling older people aged 60 years old or above;
• handgrip strength \< 28 kg for men and \< 18 kg for women;
• BMI ≥ 28% or waist circumference ≥ 85 cm in men and ≥ 80 cm in women;
• be able to read and write without severe hearing and vision problems.

You may not qualify if:

• suffering from severe heart disease or metabolic disorders (e.g. renal diseases, diabetes) or autoimmune disease, cancer, or any other diseases/ conditions which may affect food intake and digestion or amputee;
• cognitively impaired (e.g. dementia) may impede the delivery of the intervention;
• under special diet restriction such as on diabetes disease diet, vegetarian, ketogenic diet, etc.;
• using of medications that may influence eating behavior, digestion or metabolism (such as weight loss medication);
• addicted to alcohol;
• a metal device is implanted in the body;
• be engaged in another trials.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Jiangning Dongshan Community Healthcare Center

Nanjing, Jiangsu, 210000, China

Location

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Study Officials

• Justina Liu, PhD

  The Hong Kong Polytechnic University

  STUDY CHAIR

• Yueheng Yin, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

• Maritta Valimaki, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: December 31, 2020
• Study Start: July 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)