NCT05949957

Brief Summary

Women with Gestational Diabetes Mellitus (GDM) are 12-times more likely to develop Type 2 Diabetes (T2D) 4-6 years after delivery than women without GDM. There has been evidence that lifestyle modifications such as physical activity (PA), dietary intake, sleep, and stress management can prevent or delay type 2 diabetes (T2D). The purpose of this study is to assess the efficacy of a holistic lifestyle digital health intervention with post-GDM women in large community settings in Singapore. The study consists of a 1-year randomized controlled trial (RCT) with 3 years follow-up. Women who are eligible for the study will be randomized to either Group 1 (Intervention) or Group 2 (Control) at baseline. Both groups will be followed in years 2-4. Women from both groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the "HAPPY app," which will provide health promotion information about physical activity, diet, sleep, and mental wellbeing, as well as display the information collected (such as body mass index, blood pressure, and OGTT results). The active group will receive the "LVL UP app" a smartphone-based chatbot-delivered intervention, designed to provide personalized recommendations through multiple digital coaching sessions aimed at improving health literacy and practicing healthy lifestyles to prevent Type 2 diabetes and common mental disorders (i.e., anxiety, depression).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
4mo left

Started Oct 2023

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2023Sep 2026

First Submitted

Initial submission to the registry

June 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

June 8, 2023

Last Update Submit

May 13, 2025

Conditions

Type 2 DiabetesHealthy Lifestyle BehaviorsGestational Diabetes

Keywords

Type 2 DiabetesGestational Diabetes MellitusWomenPreventionHealthy lifestylePhysical activityDietSleepMental wellbeingDigital health interventions

Outcome Measures

Primary Outcomes (1)

  • Glucose Tolerance Changes

    2-hr 75g Oral Glucose Tolerance Test (OGTT)

    Changes in glucose over four years, including: Baseline, Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)

Secondary Outcomes (13)

  • Anthropometric Measurements

    Baseline, Week 26/27 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)

  • Blood pressure (BP)

    Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)

  • Biosample Collection (Fasting blood)

    Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)

  • Biosample Collection (Saliva)

    Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)

  • Biosample Collection (Buccal swab)

    Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)

  • +8 more secondary outcomes

Other Outcomes (9)

  • Cognitive emotion regulation strategies

    Baseline, Week 26 (Midpoint Visit), Year1

  • Sleep wake up

    Baseline, Week 26 (Midpoint Visit), Year1

  • Happiness

    Baseline, Week 26 (Midpoint Visit), Year1

  • +6 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

LvL UP App (Smarphone-based conversational agent-delivered holistic lifestyle intervention for the prevention of type 2 diabetes, and common mental disorders \[anxiety, depression\]). HAPPY App (Health promotion information, and display health data collected) Oura ring and Oura App (activity-tracking wearable that collects lifestyle data \[physical activity, sleep and heart rate\]).

Behavioral: LvL UP AppBehavioral: HAPPY AppBehavioral: Oura Ring And Oura App

Control group

ACTIVE COMPARATOR

HAPPY App (Health promotion information, and display health data collected) Oura ring and Oura App (activity-tracking wearable that collects lifestyle data \[physical activity, sleep and heart rate\]).

Behavioral: HAPPY AppBehavioral: Oura Ring And Oura App

Interventions

LvL UP AppBEHAVIORAL

LvL UP App: A Smartphone-based conversational agent-delivered holistic lifestyle intervention. The intervention group will receive several digital coaching sessions focus on 3 pillars: diet, physical activity, and mental well-being to promote health literacy and promote healthy lifestyles. The app includes practical exercises per pillar (e.g., journaling, slow-breathing exercises, lifehacks).

Intervention group
HAPPY AppBEHAVIORAL

HAPPY App: Each subject will use the HAPPY App that aims to:(1) deliver health promotion information (guided by Singapore Health Promotion Board's resources), and (2) display health data collected (e.g., body mass index, blood pressure, OGTT results) that help them monitor own health and prevent T2D.

Control groupIntervention group
Oura Ring And Oura AppBEHAVIORAL

Oura ring and Oura App: Each subject will receive an Oura ring, i.e., an activity-tracking wearable that collects lifestyle data (physical activity, sleep and heart rate (as a proxy for stress) that will be synced with Oura App

Control groupIntervention group

Eligibility Criteria

Age21 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female, age: 21 - 45 years
  • Had a history of GDM (at least 1 year and not more than 10 years)
  • Chinese, Malay or Indian ethnic groups
  • Body mass index (at least 18.5 kg/m2 and not more than 35 kg/m2)
  • Not planning to conceive in the next one year
  • Not performing exclusive breastfeeding during study period
  • Own a smartphone compatible with the study mobile Apps
  • Proficient in English language
  • Plan to stay in Singapore for the next 4 years
  • Willing to comply to study protocol
  • Able to provide a written informed consent

You may not qualify if:

  • Current or previous diagnosis of diabetes (Type 1 or 2), except GDM
  • Currently pregnant
  • Given birth within the last 12 weeks
  • Severely limited mobility (e.g., wheelchair bound, require long-term walking aid, etc.)
  • Diagnosed with malnutrition or eating disorder
  • Diagnosed with cancers, unstable heart diseases, severe kidney diseases, severe liver diseases
  • Diagnosed with severe insomnia, unstable mental conditions, dementia, or cognitive impairment
  • Experienced alcohol or drug abuse
  • Currently having medications known to influence glucose metabolism (e.g. peroral corticosteroids)
  • Currently participating in concurrent clinical trial or lifestyle intervention study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute for Clinical Sciences (SICS)

Singapore, Singapore, 117549, Singapore

Location

Related Publications (1)

  • Salamanca-Sanabria A, Liew SJ, Mair J, De Iorio M, Ling YDY, Tint MT, Wei YT, Lim K, Ong D, Chooi YC, Tay V, Eriksson JG. A holistic lifestyle mobile health intervention for the prevention of type 2 diabetes and common mental disorders in Asian women with a history of gestational diabetes: a randomised control trial with 3-year follow-up protocol. Trials. 2024 Jul 3;25(1):443. doi: 10.1186/s13063-024-08247-x.

    PMID: 38961430DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, GestationalMotor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A parallel 2-arm, single-Centre Randomized Control Trial based on 1:1 allocation ratio. Eligible women will be randomized at baseline to either Group 1 (Intervention) or Group 2 (Control). Participants will receive the assigned intervention from baseline to 1 year, followed by 3 years follow-up period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Principal Investigator

Study Record Dates

First Submitted

June 8, 2023

First Posted

July 18, 2023

Study Start

October 20, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)