Weight Loss Interventions for Obesity

NCT06022796 | Unknown

• 1 other identifier: 202300165
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Weight Loss; Ketogenic Dieting; Obesity

Outcome Measures

Primary Outcomes (1)

• Body weight

  Weight changes post-intervention

  1 month, 3 months, 6 months

Secondary Outcomes (11)

• Blood pressure

  3 months, 6 months

• Hemoglobin A1c

  3 months, 6 months

• Fasting blood glucose

  3 months, 6 months

• Total cholesterol

  3 months, 6 months

• Low-density lipoprotein cholesterol

  3 months, 6 months

Study Arms (2)

Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals

EXPERIMENTAL

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

Healthy Ketogenic Diet (HKD)

ACTIVE COMPARATOR

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

Interventions

Healthy Ketogenic Ready-to-Eat Meals OTHER

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.

Also known as: Very low carbohydrate diet

Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals

Healthy Ketogenic Diet OTHER

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

Healthy Ketogenic Diet (HKD)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Overweight; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Melissa Tay

CONTACT

67725166; melissa_hj_tay@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not feasible to apply blinding to the study design due to the nature of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: July 21, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

SG (1)