Weight Loss Interventions for Obesity

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight; Weight Loss; Ketogenic Dieting
• Intervention / Treatment: Other: Healthy Ketogenic Ready-to-Eat Meals; Other: Healthy Ketogenic Diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Tay; Phone Number: 67725166; Email: melissa_hj_tay@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Melissa Tay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals; Participants in the HK-RTE group (n=25) will be provided with the Healthfull meals for lunch and dinner in the first month. They will be advised to take these meals as part of a healthy ketogenic diet, with a maximum of 50g total net carbohydrates daily. Participants will receive nutrition education conducted by dietitians over the course of 6 months (total of 5 dietary workshops covering topics such as ketogenic dietary advice and self-monitoring habits). Participants will also receive health coaching via the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6 months study period.	Other: Healthy 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.; Other Names: Very low carbohydrate diet
Active Comparator: Healthy Ketogenic Diet (HKD); Participants in the reference group will be instructed to follow a Healthy Ketogenic Diet (n = 25), with a maximum of 50g total net carbohydrates daily. Similar to the experimental group, participants will receive nutrition education conducted by dietitians over the course of 6 months (total of 5 dietary workshops such as ketogenic dietary advice and self-monitoring habit). Participants will also receive health coaching via the Nutritionist Buddy (nBuddy) mobile application to facilitate monitoring of diet intake, physical activity and weight throughout the 6 months study period.	Other: Healthy Ketogenic Diet; Participants will receive nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet, without the provision of HK-RTE meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Weight changes post-intervention	1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Systolic and diastolic changes at follow up appointments	3 months, 6 months
Hemoglobin A1c	HbA1c changes at follow up appointments	3 months, 6 months
Fasting blood glucose	Fasting blood glucose changes at follow up appointments	3 months, 6 months
Total cholesterol	Cholesterol changes at follow up appointments	3 months, 6 months
Low-density lipoprotein cholesterol	Cholesterol changes at follow up appointments	3 months, 6 months
High-density lipoprotein cholesterol	Cholesterol changes at follow-up appointments	3 months, 6 months
Triglycerides	Triglycerides changes at follow up appointments	3 months, 6 months
Motivation to initiate and maintain dietary behaviours	Motivation via self-reported questionnaire	3 months, 6 months
Perceived competence to maintain dietary behaviour	Perceived competence via self-reported questionnaire	3 months, 6 months
Hunger	Subjective ratings of hunger feelings via self-reported questionnaire	3 months, 6 months
Dietary intake	Nutrients intake by assessing food logs in nBuddy application	6 months

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight Changes; Obesity; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: 202300165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No