Trials / Completed
CompletedNCT04690985
Dietary Behaviour Change Intervention Among Older People With Sarcopenic Obesity
Dietary Behaviour Change Intervention on Managing Sarcopenic Obesity in Community-dwelling Older People: a Feasibility and Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- The Hong Kong Polytechnic University · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2021-02-28
- Completion
- 2021-02-28
- First posted
- 2020-12-31
- Last updated
- 2022-08-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04690985. Inclusion in this directory is not an endorsement.