Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690985
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2020-10-19
Brief Title:
Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Dietary Behaviour Change Intervention on Managing Sarcopenic Obesity in Community-dwelling Older People a Feasibility and Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N60 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
The feasibility and preliminary effects of the intervention will be tested using a two-armed pilot randomized controlled trial among older people N60 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 11 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 12-15 gbody weight kgday 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
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 12-15 gbody weight kgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None