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Sarcopenic ObesityNCT04690985

Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity

A study testing Dietary behaviour change and Social contact in people with Sarcopenic Obesity, run by The Hong Kong Polytechnic University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Sarcopenic Obesity
What is being tested?
Dietary behaviour change and Social contact
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteChina
Study dates
1 Jul 2020to 28 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangning Dongshan Community Healthcare Center

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Dietary behaviour change, Social contact
Keywords
dietary behaviour change, sarcopenic obesity, community, randomized controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary behaviour changeBehavioural

    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 contactOther

    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.

Study groups in NCT04690985
Study groupRoleWhat they receive
Control groupSham comparatorThe 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.
Receives: Other: Social contact
Experimental groupExperimentalThe 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.
Receives: Behavioral: Dietary behaviour change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of muscle strength

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

    Measured: Change from baseline to 1 week after the programme

  2. 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).

    Measured: Change from baseline to 1 week after the programme

  3. Changes of skeletal muscle mass

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

    Measured: Change from baseline to 1 week after the programme

  4. Changes of body weight

    Body weight (kg) will be measured.

    Measured: Change from baseline to 1 week after the programme

  5. Changes of fat mass

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

    Measured: Change from baseline to 1 week after the programme

  6. 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.

    Measured: Change from baseline to 1 week after the programme

  7. Changes of body mass index

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

    Measured: Change from baseline to 1 week after the programme

  8. Changes of percentage of body fat

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

    Measured: Change from baseline to 1 week after the programme

  9. Changes of waist-to-hip ratio

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

    Measured: Change from baseline to 1 week after the programme

  10. Recruitment rate

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

    Measured: Baseline

  11. Attrition rate

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

    Measured: At the end of the 15-week programme

  12. Adherence to diet regimen

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

    Measured: Throughout the 15-week programme

  13. Occurrence of adverse events

    Any adverse events at home will be recorded.

    Measured: Throughout the 15-week programme

Secondary outcomes (5)

  1. 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).

    Measured: Change from baseline to 1 week after the programme

  2. 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.

    Measured: Change from baseline to 1 week after the programme

  3. 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.

    Measured: Change from baseline to 1 week after the programme

  4. 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.

    Measured: Change from baseline to 1 week after the programme

  5. 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.

    Measured: Change from baseline to 1 week after the programme

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2020
  2. Study start1 Jul 2020
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690985
Sponsor's protocol ID
HSEARS20191007001
Status last verified
Aug 2022
First submitted
19 Oct 2020
Last updated
19 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: For confidentiality, the data will be kept anonymous and the information of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 3 years after the completion of this research.

Publications

  • Anthony TG. Mechanisms of protein balance in skeletal muscle. Domest Anim Endocrinol. 2016 Jul;56 Suppl(Suppl):S23-32. doi: 10.1016/j.domaniend.2016.02.012.

    PubMed 27345321

  • Bergamini E, Cavallini G, Donati A, Gori Z. The anti-ageing effects of caloric restriction may involve stimulation of macroautophagy and lysosomal degradation, and can be intensified pharmacologically. Biomed Pharmacother. 2003 Jul-Aug;57(5-6):203-8. doi: 10.1016/s0753-3322(03)00048-9.

    PubMed 12888255

  • Beasley JM, Shikany JM, Thomson CA. The role of dietary protein intake in the prevention of sarcopenia of aging. Nutr Clin Pract. 2013 Dec;28(6):684-90. doi: 10.1177/0884533613507607. Epub 2013 Oct 25.

    PubMed 24163319

  • Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.

    PubMed 15367063

  • Chen C, Lu FC; Department of Disease Control Ministry of Health, PR China. The guidelines for prevention and control of overweight and obesity in Chinese adults. Biomed Environ Sci. 2004;17 Suppl:1-36. No abstract available.

    PubMed 15807475

  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

    PubMed 32033882

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PubMed 31081853

  • Goisser S, Kemmler W, Porzel S, Volkert D, Sieber CC, Bollheimer LC, Freiberger E. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons--a narrative review. Clin Interv Aging. 2015 Aug 6;10:1267-82. doi: 10.2147/CIA.S82454. eCollection 2015.

    PubMed 26346071

  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PubMed 18183564

  • Schwarzer R, Renner B. Social-cognitive predictors of health behavior: action self-efficacy and coping self-efficacy. Health Psychol. 2000 Sep;19(5):487-95.

    PubMed 11007157

  • Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

    PubMed 21767036

  • Yin YH, Liu JYW, Valimaki M. Effectiveness of non-pharmacological interventions on the management of sarcopenic obesity: A systematic review and meta-analysis. Exp Gerontol. 2020 Jul 1;135:110937. doi: 10.1016/j.exger.2020.110937. Epub 2020 Mar 30.

    PubMed 32240820

  • Li L, Wang HM, Shen Y. Chinese SF-36 Health Survey: translation, cultural adaptation, validation, and normalisation. J Epidemiol Community Health. 2003 Apr;57(4):259-63. doi: 10.1136/jech.57.4.259.

    PubMed 12646540

  • Zhang CX, Ho SC. Validity and reproducibility of a food frequency Questionnaire among Chinese women in Guangdong province. Asia Pac J Clin Nutr. 2009;18(2):240-50.

    PubMed 19713184

  • Lee PH, Yu YY, McDowell I, Leung GM, Lam TH, Stewart SM. Performance of the international physical activity questionnaire (short form) in subgroups of the Hong Kong chinese population. Int J Behav Nutr Phys Act. 2011 Aug 1;8:81. doi: 10.1186/1479-5868-8-81.

    PubMed 21801461

Questions about this trial

What is this clinical trial studying?

A study testing Dietary behaviour change and Social contact in people with Sarcopenic Obesity, run by The Hong Kong Polytechnic University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of muscle strength (time frame: Change from baseline to 1 week after the programme). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04690985, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.

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