Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Completed

CT.gov ID

NCT04690985

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenic Obesity	Behavioral: Dietary behaviour change Other: Social contact	N/A

Detailed Description

The pilot study is a single-blind, two-arm randomized controlled trial. A total of 60 subjects (60 years old or more) are planned to be recruited. The subjects will be randomly divided into 2 groups witht a ratio of 1:1. One is the experimental group and the other is the control group.

The experimental group will receive 15 weeks of dietary intervention, including 6 face-to-face meetings and weekly telephone call. Each meeting lasts for 1 hour. The participants in the experimental group are required to control of calorie intake (decrease energy intake by 12%) and increase protein intake (1.2-1.5 g/body weight kg/day), and take dietary diary.

The control group will not receive any dietary interventions. They will only receive regular contacts with a similar frequency as the experimental group. The content of the conversations will not involve any topics related to SO.

After the intervention, 10-15 people from the experimental group will be randomly selected to receive semi-structured individual interview, which will last around 1 hour. The researcher plan to understand their feelings about participating in the study.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Dietary Behaviour Change Intervention on Managing Sarcopenic Obesity in Community-dwelling Older People: a Feasibility and Pilot Study

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Feb 28, 2021

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control group 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 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.
Experimental: Experimental group 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 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.

Arm

Intervention/Treatment

Sham Comparator: Control group

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

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.

Experimental: Experimental group

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

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.

Outcome Measures

Primary Outcome Measures

Changes of muscle strength [Change from baseline to 1 week after the programme]
Handgrip strength (kg) will be measured by using the jamar dynamometer.
Changes of physical function [Change from baseline to 1 week after the programme]
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).
Changes of skeletal muscle mass [Change from baseline to 1 week after the programme]
Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of body weight [Change from baseline to 1 week after the programme]
Body weight (kg) will be measured.
Changes of fat mass [Change from baseline to 1 week after the programme]
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Changes of visceral fat score [Change from baseline to 1 week after the programme]
Visceral fat score will be measured by using bioelectrical impedance analysis. Maintain a visceral fat score below 10 means good health.
Changes of body mass index [Change from baseline to 1 week after the programme]
The weight and height will be combined to report BMI in kg/m^2.
Changes of percentage of body fat [Change from baseline to 1 week after the programme]
Percentage of body fat will be reported by the percent of body fat mass in whole body weight.
Changes of waist-to-hip ratio [Change from baseline to 1 week after the programme]
Waist circumference(cm) and hip circumference (cm) will be measured to report the waist-to-hip ratio.
Recruitment rate [Baseline]
The proportion of participants who consent to join the study over the eligible participants.
Attrition rate [At the end of the 15-week programme]
The percentage of participants who withdraw from the study and their reasons for withdrawing.
Adherence to diet regimen [Throughout the 15-week programme]
Diet adherence will be assessed by the session attendance (Rate of attendance in 6 sessions).
Occurrence of adverse events [Throughout the 15-week programme]
Any adverse events at home will be recorded.

Secondary Outcome Measures

Mini Nutritional Assessment (MNA) Short-form [Change from baseline to 1 week after the programme]
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 ponits per item. Scores are categoried as 0-7 (malnourished), 8-11 (at risk of malnutrition), 12-14 (normal nutritional status).
Nutrition Self-efficacy Scale [Change from baseline to 1 week after the programme]
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.
Dietary quality index-International [Change from baseline to 1 week after the programme]
The DQI-I will be used to estimate the dietary quality of participants. It is a well-used questionnaire without being affected by culture.
Short Form Health Survey (SF-36) [Change from baseline to 1 week after the programme]
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health, which is always used to assess people's health status and quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
International Physical Activity Questionnaire Short-form (IPAQ-SF) [Change from baseline to 1 week after the programme]
The International Physical Activity Questionnaires Short-form (IPAQ-SF) contains (4 generic items, which is used to evaluate the vigorous activities that participants did in the last 7 days. MET minutes represent the amount of energy expended carrying out physical activity. The higher score means engaging in higher level of physical activity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangning Dongshan Community Healthcare Center	Nanjing	Jiangsu	China	210000

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

Study Chair: Justina Liu, PhD, The Hong Kong Polytechnic University
Principal Investigator: Yueheng Yin, PhD, The Hong Kong Polytechnic University
Principal Investigator: Maritta Valimaki, PhD, The Hong Kong Polytechnic University