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Weight Loss Interventions for Obesity

Weight Loss Interventions for Obesity

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06022796
Enrollment
50
Registered
2023-09-05
Start date
2023-07-21
Completion date
2024-05-01
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketogenic Dieting, Obesity, Overweight, Weight Loss

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.

Interventions

OTHERHealthy Ketogenic Ready-to-Eat Meals

Participants will be provided nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet. In addition, HK-RTE meals will be provided to participants as a form of meal replacement for lunch and dinner over 1 month. Participants will be expected to follow a healthy ketogenic diet thereafter.

OTHERHealthy Ketogenic Diet

Participants will receive nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet, without the provision of HK-RTE meals.

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

It is not feasible to apply blinding to the study design due to the nature of the intervention

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).

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Body weight1 month, 3 months, 6 monthsWeight changes post-intervention

Secondary

MeasureTime frameDescription
Hemoglobin A1c3 months, 6 monthsHbA1c changes at follow up appointments
Fasting blood glucose3 months, 6 monthsFasting blood glucose changes at follow up appointments
Total cholesterol3 months, 6 monthsCholesterol changes at follow up appointments
Low-density lipoprotein cholesterol3 months, 6 monthsCholesterol changes at follow up appointments
High-density lipoprotein cholesterol3 months, 6 monthsCholesterol changes at follow-up appointments
Blood pressure3 months, 6 monthsSystolic and diastolic changes at follow up appointments
Motivation to initiate and maintain dietary behaviours3 months, 6 monthsMotivation via self-reported questionnaire
Perceived competence to maintain dietary behaviour3 months, 6 monthsPerceived competence via self-reported questionnaire
Hunger3 months, 6 monthsSubjective ratings of hunger feelings via self-reported questionnaire
Dietary intake6 monthsNutrients intake by assessing food logs in nBuddy application
Triglycerides3 months, 6 monthsTriglycerides changes at follow up appointments

Countries

Singapore

Contacts

Primary ContactMelissa Tay
melissa_hj_tay@nuhs.edu.sg67725166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026