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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Jiangning Dongshan Community Healthcare Center
Nanjing, Jiangsu, China
Changes of muscle strength
Handgrip strength (kg) will be measured by using the jamar dynamometer.
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline to 1 week after the programme
Changes of body weight
Body weight (kg) will be measured.
Time frame: Change from baseline to 1 week after the programme
Changes of fat mass
Fat mass (kg) will be measured by using bioelectrical impedance analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Attrition rate
The percentage of participants who withdraw from the study and their reasons for withdrawing.
Time frame: 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).
Time frame: Throughout the 15-week programme
Occurrence of adverse events
Any adverse events at home will be recorded.
Time frame: Throughout the 15-week programme
Mini Nutritional Assessment (MNA) Short-form
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).
Time frame: Change from baseline to 1 week after the programme
Nutrition Self-efficacy Scale
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.
Time frame: Change from baseline to 1 week after the programme
Dietary quality index-International
The DQI-I will be used to estimate the dietary quality of participants. It is a well-used questionnaire without being affected by culture.
Time frame: Change from baseline to 1 week after the programme
Short Form Health Survey (SF-36)
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.
Time frame: Change from baseline to 1 week after the programme
International Physical Activity Questionnaire Short-form (IPAQ-SF)
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.
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Time frame: Change from baseline to 1 week after the programme