Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity
NCT ID: NCT04690985
Last Updated: 2022-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-07-01
2021-02-28
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
The 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.
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.
Experimental group
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 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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Dr. Justina Liu Yat Wa
Associate Professor
Principal Investigators
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Justina Liu, PhD
Role: STUDY_CHAIR
The Hong Kong Polytechnic University
Yueheng Yin, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Maritta Valimaki, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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Jiangning Dongshan Community Healthcare Center
Nanjing, Jiangsu, China
Countries
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References
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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.
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HSEARS20191007001
Identifier Type: -
Identifier Source: org_study_id
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