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Weight Loss Interventions for Obesity

Primary Purpose

Overweight, Weight Loss, Ketogenic Dieting

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Healthy Ketogenic Ready-to-Eat Meals
Healthy Ketogenic Diet
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Healthy Ketogenic Diet (HKD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body weight
Weight changes post-intervention

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2023
Last Updated
August 28, 2023
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT06022796
Brief Title
Weight Loss Interventions for Obesity
Official Title
Weight Loss Interventions for Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Weight Loss, Ketogenic Dieting, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Masking Description
It is not feasible to apply blinding to the study design due to the nature of the intervention
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Ketogenic Ready-To-Eat (HK-RTE) Meals
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Ketogenic Diet (HKD)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy Ketogenic Ready-to-Eat Meals
Other Intervention Name(s)
Very low carbohydrate diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy Ketogenic Diet
Intervention Description
Participants will receive nutrition education via 5 dietary workshops focusing on a healthy ketogenic diet, without the provision of HK-RTE meals.
Primary Outcome Measure Information:
Title
Body weight
Description
Weight changes post-intervention
Time Frame
1 month, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic changes at follow up appointments
Time Frame
3 months, 6 months
Title
Hemoglobin A1c
Description
HbA1c changes at follow up appointments
Time Frame
3 months, 6 months
Title
Fasting blood glucose
Description
Fasting blood glucose changes at follow up appointments
Time Frame
3 months, 6 months
Title
Total cholesterol
Description
Cholesterol changes at follow up appointments
Time Frame
3 months, 6 months
Title
Low-density lipoprotein cholesterol
Description
Cholesterol changes at follow up appointments
Time Frame
3 months, 6 months
Title
High-density lipoprotein cholesterol
Description
Cholesterol changes at follow-up appointments
Time Frame
3 months, 6 months
Title
Triglycerides
Description
Triglycerides changes at follow up appointments
Time Frame
3 months, 6 months
Title
Motivation to initiate and maintain dietary behaviours
Description
Motivation via self-reported questionnaire
Time Frame
3 months, 6 months
Title
Perceived competence to maintain dietary behaviour
Description
Perceived competence via self-reported questionnaire
Time Frame
3 months, 6 months
Title
Hunger
Description
Subjective ratings of hunger feelings via self-reported questionnaire
Time Frame
3 months, 6 months
Title
Dietary intake
Description
Nutrients intake by assessing food logs in nBuddy application
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Tay
Phone
67725166
Email
melissa_hj_tay@nuhs.edu.sg
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Tay

12. IPD Sharing Statement

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Weight Loss Interventions for Obesity

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