Improving Weight Loss in Healthy Adults With Overweight and Obesity: An Artificial Intelligence-assisted Dietary Prediction and Prevention System With Continuous Glucose Monitoring
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Singapore, Singapore, 117597
- National University of Singapore
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- are 21-65 years old
- have BMI ≥23 kg/m2
- can comprehend the English language
- uses a smartphone that can download apps
- are willing to perform continuous glucose monitoring (CGM) using the Dexcom continuous glucose monitoring system
- willing to travel to the National University of Singapore (NUS)
- able to provide informed consent
Exclusion Criteria:
- are using/intend to use other apps for weight loss;
- are pregnant or lactating (as it would affect weight change and caloric needs)
- are diagnosed severe mental disorders (e.g. major depressive disorder and schizophrenia)
- are on prescribed meal replacements or pharmacotherapy
- have serious medical conditions
- are scheduled for any kind of surgery within the next 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: eTRIP smartphone application
Intervention group 1 involves using the eating behaviour trigger-response inhibition program(eTRIP) smartphone application for 10 weeks, where participants will need to take pictures of their food items as part of their food logging and may also engage with app-based activities to build self-regulatory skills in sticking to their weight loss plans.
Additionally, participants will also apply a continuous glucose monitoring (CGM) sensor on their arm and taught how to scan the CGM sensor so that they can monitor their glucose levels for the first 10 days.
|
Intervention group 1 involves using the eating behaviour trigger-response inhibition program(eTRIP) smartphone application for 10 weeks, where participants will need to take pictures of their food items as part of their food logging and may also engage with app-based activities to build self-regulatory skills in sticking to their weight loss plans.
Additionally, participants will also apply a continuous glucose monitoring (CGM) sensor on their arm and taught how to scan the CGM sensor so that they can monitor their glucose levels for the first 10 days.
|
|
Sham Comparator: FatSecret smartphone application
Intervention group 2 involves using the FatSecret smartphone application for participants to monitor their calorie intake, without any continuous glucose monitoring.
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Intervention group 2 involves using the FatSecret smartphone application for participants to monitor their calorie intake, without any continuous glucose monitoring.
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|
No Intervention: Control
Control group will not receive any smartphone application or continuous glucose monitoring.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: At weeks 0, 10 and 24.
|
Taken using a wall mounted measuring tape.
|
At weeks 0, 10 and 24.
|
|
Weight
Time Frame: At weeks 0, 10 and 24.
|
Taken using InBody 120
|
At weeks 0, 10 and 24.
|
|
Waist Circumference
Time Frame: At weeks 0, 10 and 24.
|
Taken using a measuring tape.
|
At weeks 0, 10 and 24.
|
|
BMI
Time Frame: At weeks 0, 10 and 24.
|
Taken using InBody 120
|
At weeks 0, 10 and 24.
|
|
Self regulation of Eating Behaviour Questionnaire (SREBQ)
Time Frame: At weeks 0, 10 and 24.
|
The Self-Regulation of Eating Behaviour Questionnaire (SREBQ) is a validated self-administered instrument used to assess individuals' self-regulation in relation to eating behavior.
It evaluates the extent to which individuals monitor, control, and regulate their eating behaviors in everyday contexts.
Higher scores indicate greater self-regulation of eating behavior.
|
At weeks 0, 10 and 24.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-2 (PHQ-2)
Time Frame: At weeks 0, 10 and 24.
|
The Patient Health Questionnaire - 2 item (PHQ-2) is a validated self-administered screening questionnaire used to assess the frequency of depressive symptoms over the past two weeks.
Higher scores indicate greater depressive symptom severity.
|
At weeks 0, 10 and 24.
|
|
Euro Quality of life 5 Dimensions-5 Levels (EQ-5D-5L)
Time Frame: At weeks 0, 10 and 24.
|
The EuroQol 5 Dimensions - 5 Levels (EQ-5D-5L) is a standardized self-administered instrument used to assess health-related quality of life.
It measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five response levels.
|
At weeks 0, 10 and 24.
|
|
Generalized Anxiety Disorder 2-item (GAD-2)
Time Frame: At weeks 0, 10 and 24.
|
The Generalized Anxiety Disorder - 2 item (GAD-2) is a validated self-administered screening questionnaire used to assess the frequency of core anxiety symptoms over the past two weeks.
Higher scores indicate greater anxiety symptom severity.
|
At weeks 0, 10 and 24.
|
|
Percentage Body Fat
Time Frame: At weeks 0, 10 and 24.
|
Taken using InBody 120.
|
At weeks 0, 10 and 24.
|
|
Body Fat Mass
Time Frame: At weeks 0, 10 and 24.
|
Taken using InBody 120.
|
At weeks 0, 10 and 24.
|
|
Three Factor Eating Questionnaire (TFEQ)
Time Frame: At weeks 0, 10 and 24.
|
The Three-Factor Eating Questionnaire (TFEQ) is a validated self-administered instrument used to assess eating-related behaviors.
It measures three domains: cognitive restraint of eating, uncontrolled eating, and emotional eating.
Higher scores indicate greater levels of the respective eating behavior.
|
At weeks 0, 10 and 24.
|
|
International Physical Activity Questionnaire Short-Form (IPAQ-SF)
Time Frame: At weeks 0, 10 and 24.
|
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated self-administered questionnaire used to assess self-reported physical activity levels.
It captures the frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity performed over the past 7 days.
|
At weeks 0, 10 and 24.
|
|
Self-Report Behavioural Automaticity Index (SRBAI)
Time Frame: At weeks 0, 10 and 24.
|
The Self-Report Behavioural Automaticity Index (SRBAI) is a validated self-administered questionnaire used to assess the automaticity of behavior.
It evaluates the extent to which a behavior is performed automatically, with little conscious thought or deliberation.
Higher scores indicate greater behavioral automaticity.
|
At weeks 0, 10 and 24.
|
|
Consideration of Future Consequences Scale (CFCS-6)
Time Frame: At weeks 0, 10 and 24.
|
The Consideration of Future Consequences Scale - 6 item (CFCS-6) is a validated self-administered questionnaire used to assess the extent to which individuals consider the potential future outcomes of their current behaviors.
It evaluates the degree to which individuals weigh immediate versus future consequences when making decisions.
Higher scores indicate greater consideration of future consequences.
|
At weeks 0, 10 and 24.
|
|
Skeletal Muscle Mass
Time Frame: At weeks 0,10 and 24.
|
Taken using InBody 120.
|
At weeks 0,10 and 24.
|
|
Visceral Fat Level
Time Frame: At weeks 0, 10 and 24.
|
Taken using InBody 120.
|
At weeks 0, 10 and 24.
|
|
Big Five Inventory - 44 item (BFI-44)
Time Frame: At weeks 0, 10 and 24.
|
The Big Five Inventory - 44 item (BFI-44) is a validated self-administered questionnaire used to assess personality traits across five domains: openness, conscientiousness, extraversion, agreeableness, and neuroticism.
Higher scores indicate greater expression of the respective personality traits.
|
At weeks 0, 10 and 24.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NUS-IRB-2023-597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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