Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity

Sarcopenic Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690985
• Other study ID #: HSEARS20191007001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Sarcopenic Obesity

Intervention

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.

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.

Locations

Country	Name	City	State
China	Jiangning Dongshan Community Healthcare Center	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

References & Publications (21)

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

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère 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. — View Citation

Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznariç Z, Nair KS, Singer P, Teta D, Tipton K, Calder PC. Protein intake and exercise for optimal muscle function with aging: recommendations from the ESPEN Expert Group. Clin Nutr. 2014 Dec;33(6):929-36. doi: 10.1016/j.clnu.2014.04.007. Epub 2014 Apr 24. — View Citation

Fontana L, Klein S. Aging, adiposity, and calorie restriction. JAMA. 2007 Mar 7;297(9):986-94. Review. — View Citation

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. Review. — View Citation

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

Kraus WE, Bhapkar M, Huffman KM, Pieper CF, Krupa Das S, Redman LM, Villareal DT, Rochon J, Roberts SB, Ravussin E, Holloszy JO, Fontana L; CALERIE Investigators. 2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Sep;7(9):673-683. doi: 10.1016/S2213-8587(19)30151-2. Epub 2019 Jul 11. — View Citation

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. — View Citation

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. — View Citation

Morley JE, Argiles JM, Evans WJ, Bhasin S, Cella D, Deutz NE, Doehner W, Fearon KC, Ferrucci L, Hellerstein MK, Kalantar-Zadeh K, Lochs H, MacDonald N, Mulligan K, Muscaritoli M, Ponikowski P, Posthauer ME, Rossi Fanelli F, Schambelan M, Schols AM, Schuster MW, Anker SD; Society for Sarcopenia, Cachexia, and Wasting Disease. Nutritional recommendations for the management of sarcopenia. J Am Med Dir Assoc. 2010 Jul;11(6):391-6. doi: 10.1016/j.jamda.2010.04.014. Review. — View Citation

Newman AB, Lee JS, Visser M, Goodpaster BH, Kritchevsky SB, Tylavsky FA, Nevitt M, Harris TB. Weight change and the conservation of lean mass in old age: the Health, Aging and Body Composition Study. Am J Clin Nutr. 2005 Oct;82(4):872-8; quiz 915-6. — View Citation

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. — View Citation

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. — View Citation

Yin YH, Liu JYW, Välimäki 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. Review. — View Citation

Zhang CQ, Zhang R, Schwarzer R, Hagger MS. A meta-analysis of the health action process approach. Health Psychol. 2019 Jul;38(7):623-637. doi: 10.1037/hea0000728. Epub 2019 Apr 11. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of muscle strength	Handgrip strength (kg) will be measured by using the jamar dynamometer.	Change from baseline to 1 week after the programme
Primary	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
Primary	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
Primary	Changes of body weight	Body weight (kg) will be measured.	Change from baseline to 1 week after the programme
Primary	Changes of fat mass	Fat mass (kg) will be measured by using bioelectrical impedance analysis.	Change from baseline to 1 week after the programme
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Recruitment rate	The proportion of participants who consent to join the study over the eligible participants.	Baseline
Primary	Attrition rate	The percentage of participants who withdraw from the study and their reasons for withdrawing.	At the end of the 15-week programme
Primary	Adherence to diet regimen	Diet adherence will be assessed by the session attendance (Rate of attendance in 6 sessions).	Throughout the 15-week programme
Primary	Occurrence of adverse events	Any adverse events at home will be recorded.	Throughout the 15-week programme
Secondary	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).	Change from baseline to 1 week after the programme
Secondary	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.	Change from baseline to 1 week after the programme
Secondary	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.	Change from baseline to 1 week after the programme
Secondary	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.	Change from baseline to 1 week after the programme
Secondary	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.	Change from baseline to 1 week after the programme