Clinical trial NCT04690985: Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity
Official title: Dietary Behaviour Change Intervention on Managing Sarcopenic Obesity in Community-dwelling Older People: a Feasibility and Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenic Obesity
Keywords: dietary behaviour change
sarcopenic obesity
community
randomized controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of muscle strength
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of physical function
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of skeletal muscle mass
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of body weight
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of fat mass
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of visceral fat score
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of body mass index
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of percentage of body fat
timeFrame: Change from baseline to 1 week after the programme
measure: Changes of waist-to-hip ratio
timeFrame: Change from baseline to 1 week after the programme
measure: Recruitment rate
timeFrame: Baseline
measure: Attrition rate
timeFrame: At the end of the 15-week programme
measure: Adherence to diet regimen
timeFrame: Throughout the 15-week programme
measure: Occurrence of adverse events
timeFrame: Throughout the 15-week programme
Secondary outcomes:
measure: Mini Nutritional Assessment (MNA) Short-form
timeFrame: Change from baseline to 1 week after the programme
measure: Nutrition Self-efficacy Scale
timeFrame: Change from baseline to 1 week after the programme
measure: Dietary quality index-International
timeFrame: Change from baseline to 1 week after the programme
measure: Short Form Health Survey (SF-36)
timeFrame: Change from baseline to 1 week after the programme
measure: International Physical Activity Questionnaire Short-form (IPAQ-SF)
timeFrame: Change from baseline to 1 week after the programme
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangning Dongshan Community Healthcare Center
state: Jiangsu
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Justina Liu, PhD
role: STUDY_CHAIR
affiliation: The Hong Kong Polytechnic University
name: Yueheng Yin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong Polytechnic University
name: Maritta Valimaki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s0753-3322(03)00048-9.
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.
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. doi: 10.1037/0278-6133.23.5.443.
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. No abstract available.
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.
citation: 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.
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.
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.
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.
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.
citation: 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.
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. doi: 10.1136/jech.57.4.259.
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.
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.
citation: Deutz NE, Bauer JM, Barazzoni R, Biolo G, Boirie Y, Bosy-Westphal A, Cederholm T, Cruz-Jentoft A, Krznaric 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.
citation: Fontana L, Klein S. Aging, adiposity, and calorie restriction. JAMA. 2007 Mar 7;297(9):986-94. doi: 10.1001/jama.297.9.986.
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.
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.
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. doi: 10.1093/ajcn/82.4.872.
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.