Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06022796 |
| Other study ID # |
202300165 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 21, 2023 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
August 2023 |
| Source |
National University Hospital, Singapore |
| Contact |
Melissa Tay |
| Phone |
67725166 |
| Email |
melissa_hj_tay[@]nuhs.edu.sg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Numerous barriers towards weight management among Singaporeans with obesity exists, which
involves environmental and self-regulation factors (i.e. motivation and hunger). Hence, the
provision of healthy ketogenic ready-to-eat meals may be a potential solution to facilitate
initial weight loss through increasing motivation while reducing appetite and hunger levels
among these individuals. Therefore, this study will investigate the effect of healthy
ketogenic ready-to-eat meals with mHealth nutrition application versus healthy ketogenic diet
(without meal provision) with the mHealth nutrition app to facilitate weight loss and improve
metabolic outcomes among individuals with obesity.
Description:
In Singapore, the widespread availability of local meals and concerns of overconsumption due
to a lack of internal self-regulation skills for hunger predisposes an increased energy
intake. Furthermore, a lack of time, motivation, and self-efficacy in preparing healthy meals
may potentially limit the extent of weight and dietary management among local individuals
with obesity.
The ketogenic diet has consistently demonstrated beneficial effects on facilitating weight
management. This weight loss mechanism involves achieving a calorie deficit, induced state of
nutritional ketosis, and the reduction in appetite and hunger. Importantly, the weight loss
achieved from the early phase of the intervention serves as one of the key enablers in the
weight loss process. Despite these benefits, there is paucity in the literature examining the
provision of healthy ketogenic ready-to-eat (HK-RTE) meals on weight loss. Furthermore, none
of these studies explored the extent of motivation derived from the benefits of these meals,
nor included the use of mHealth self-monitoring strategies to encourage weight loss.
To address the research gap, our study aims to evaluate the effectiveness of HK-RTE meals
with mHealth app, as compared to healthy ketogenic diet (HKD) (without meal provision) using
the mHealth app on weight loss and metabolic outcomes among Asian individuals with obesity.
In this randomized controlled trial, participants will be randomized to either HK-RTE group
or the HKD group using computer-generated random sequencing. Both groups will receive
nutrition education conducted by dietitians throughout the 6-month study period (total of 5
dietary workshops covering topics such as ketogenic dietary advice and self-monitoring
habits).
The HK-RTE group will be provided with HK-RTE meals for lunch and dinner in the first month
(n = 25). They are to take these meals as part of a healthy ketogenic diet, with a maximum of
50g net total carbohydrates daily. Those in the control group will be advised to follow a
healthy ketogenic diet (HKD) without the RTE meals (n = 25) and similarly to keep to a
maximum of 50g net carbohydrates daily. Participants will also be encouraged to use the
Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake,
physical activity and weight throughout the 6-month study period. The impact of the HK-RTE
meals on motivation and appetite regulation in influencing weight loss will also be explored.
