Clinical trial NCT06022796: Weight Loss Interventions for Obesity
Official title: Weight Loss Interventions for Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Weight Loss
Ketogenic Dieting
Obesity
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this randomized controlled trial, participants in the HK-RTE group will be advised to follow a healthy ketogenic diet with RTE meals provided (n=25), with a maximum of 50g net carbohydrate intake daily. Those in the control group will be instructed to follow a healthy ketogenic diet (HKD) (n=25).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Aged 21 to 75 years old
* Body Mass Index \>= 27.5kg/m2
* Own a smartphone
* Literacy in English
* NUH staff

Exclusion Criteria:

* Intention of pregnancy; Pregnancy; Lactating individuals
* Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus on insulin treatment
* Untreated Endocrinopathy (e.g., hyper/hypothyroidism)
* Advanced kidney disease
* Abnormal liver function test assessed at screening
* Heart diseases
* Severe cognitive or psychiatric disabilities/disorders (e.g., eating disorders, depression)
* Active malignancies
* Taking medications that affect appetite or induce weight loss; previous or plans for bariatric surgery.

Primary outcomes:
measure: Body weight
timeFrame: 1 month, 3 months, 6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 3 months, 6 months
measure: Hemoglobin A1c
timeFrame: 3 months, 6 months
measure: Fasting blood glucose
timeFrame: 3 months, 6 months
measure: Total cholesterol
timeFrame: 3 months, 6 months
measure: Low-density lipoprotein cholesterol
timeFrame: 3 months, 6 months
measure: High-density lipoprotein cholesterol
timeFrame: 3 months, 6 months
measure: Triglycerides
timeFrame: 3 months, 6 months
measure: Motivation to initiate and maintain dietary behaviours
timeFrame: 3 months, 6 months
measure: Perceived competence to maintain dietary behaviour
timeFrame: 3 months, 6 months
measure: Hunger
timeFrame: 3 months, 6 months
measure: Dietary intake
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References: