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Completed

NCT Number: NCT04690985

Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity

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.

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Key information

Conditions

Sarcopenic Obesity

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiangning Dongshan Community Healthcare Center

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes of muscle strength

    Time frame: Change from baseline to 1 week after the programme

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

  2. Changes of physical function

    Time frame: 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).

  3. Changes of skeletal muscle mass

    Time frame: Change from baseline to 1 week after the programme

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

  4. Changes of body weight

    Time frame: Change from baseline to 1 week after the programme

    Body weight (kg) will be measured.

  5. Changes of fat mass

    Time frame: Change from baseline to 1 week after the programme

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

  6. Changes of visceral fat score

    Time frame: 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.

  7. Changes of body mass index

    Time frame: Change from baseline to 1 week after the programme

    The weight and height will be combined to report BMI in kg/m^2.

  8. Changes of percentage of body fat

    Time frame: 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.

  9. Changes of waist-to-hip ratio

    Time frame: 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.

  10. Recruitment rate

    Time frame: Baseline

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

  11. Attrition rate

    Time frame: At the end of the 15-week programme

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

  12. Adherence to diet regimen

    Time frame: Throughout the 15-week programme

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

  13. Occurrence of adverse events

    Time frame: Throughout the 15-week programme

    Any adverse events at home will be recorded.

Secondary outcomes

  1. Mini Nutritional Assessment (MNA) Short-form

    Time frame: 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).

  2. Nutrition Self-efficacy Scale

    Time frame: 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.

  3. Dietary quality index-International

    Time frame: 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.

  4. Short Form Health Survey (SF-36)

    Time frame: 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.

  5. International Physical Activity Questionnaire Short-form (IPAQ-SF)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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