Harnessing Human Potential and Improving Health Span in Women and Their Children

Not Applicable

Active, not recruiting

• Conditions: Type 2 Diabetes; Healthy Lifestyle Behaviors; Gestational Diabetes
• Interventions: Behavioral: LvL UP App; Behavioral: HAPPY App; Behavioral: Oura Ring And Oura App

• Registration Number: NCT05949957
• Lead Sponsor: Institute for Human Development and Potential (IHDP), Singapore

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).

Detailed Description

The overall goal of this study is to reduce the risk of Type 2 diabetes (T2D) and pre-diabetes in Asian women and their children by focusing upon a major high-risk group - women with a history of gestational diabetes (GDM) in Singapore. GDM is diabetes diagnosed for the first-time during pregnancy and has traditionally been considered a benign condition because typically glucose levels return to normal after delivery. Women with pregnancies complicated by GDM often progress to develop T2D later in life.

There is evidence that holistic lifestyle modifications that include strategies to improve dietary intake, physical activity, and mental well-being can prevent or delay the onset of type 2 diabetes. The use of digital health interventions can also assist in the prevention of T2D. However, limited studies have been conducted with Asian populations.

This study aims (1) to identify post-GDM women from large community settings in Singapore and to assess the efficacy of a holistic lifestyle digital intervention (focusing on diet, physical activity, sleep, and mental well-being) on glucose regulation with those identified women.

Secondary objectives are: (a) to examine the potential impacts of the proposed intervention on the health and well-being of subjects' family members (e.g., children); (b) to determine the diabetes risk of the subjects over a 3-year follow-up period; (c) to explore potential economic impacts of the proposed intervention (e.g., healthcare expenditures); (d) to study the importance of gut microbiota and epigenetic factors in relation to changes in glucose metabolism, and (e) to ascertain the safety of the proposed intervention.

The study is a 1-year randomized controlled trial with three years of follow-up. The primary outcomes involved the incidence of Type 2 diabetes confirmed by a 2-hr 75g Oral Glucose Tolerance Test (OGTT) over a 4-year period. Secondary outcomes are (1) incidence of impaired fasting glucose and impaired glucose tolerance; (b) changes in cardiometabolic variables (e.g., body weight, HbA1c, insulin, blood lipids, blood pressures) in the women; (c) changes in women's body composition; (d) changes in women's mental well-being (e.g., defined by BDI-II, STAI, WHO-5, PSS-4); (e) changes in the health and wellbeing of their children, and (f) a composite of major adverse events (MAE) comprising fatal and non-fatal events associated with Type 2 diabetes.

Eligible women will be randomized at baseline to either Group 1 (Intervention) or Group 2 (Control) for 1 year.

Group 1 (Intervention) consists of several virtual coaching sessions about healthy lifestyle delivered by a conversational agent (chatbot) embedded in the LvL UP App within 24 weeks (weeks 2 to 26) to complete three levels of health literacy. Additionally, individuals will receive an Oura ring at baseline (activity-tracking wearable that collects lifestyle data), as well as the HAPPY App (educational content about lifestyle and health outcomes \[e.g., body mass index, blood pressure, OGTT results\]).

Group 2 (Control) subjects will receive an Oura ring at baseline, and the HAPPY App

Follow-up Period Upon completion of the one-year RCT period, both groups will be followed-up for 3 years. During the follow-up visits, body measurements, OGTT, bio-sampling, and data collection will be conducted.

Both groups will be assessed at baseline, week 26, 1 year visit, 2-year visit (follow-up 1), 3-year visit (follow-up 2), and 4-year visit (follow-up 3)

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-07-09
• Study First Posted: 2023-07-18
• Study Start: 2023-10-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	LvL UP App	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 \[physical activity, sleep and heart rate\]).
Intervention group	Oura Ring And Oura App	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 \[physical activity, sleep and heart rate\]).
Control group	Oura Ring And Oura App	HAPPY App (Health promotion information, and display health data collected) Oura ring and Oura App (activity-tracking wearable that collects lifestyle data \[physical activity, sleep and heart rate\]).
Intervention group	HAPPY App	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 \[physical activity, sleep and heart rate\]).
Control group	HAPPY App	HAPPY App (Health promotion information, and display health data collected) Oura ring and Oura App (activity-tracking wearable that collects lifestyle data \[physical activity, sleep and heart rate\]).

Primary Outcome Measures

Name	Time	Method
Glucose Tolerance Changes	Changes in glucose over four years, including: Baseline, Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	2-hr 75g Oral Glucose Tolerance Test (OGTT)

Secondary Outcome Measures

Name	Time	Method
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)	Fasting blood draw will be analyzed for HbA1c \& fasting blood glucose
Biosample Collection (Saliva)	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	Saliva collected using Salivette® kit (cortisol)
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)	Buccal swab collected using Isohelix kit (DNA profiling)
Social-emotional development (Children)	Baseline, Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	ASQ:-3: Ages and stages questionnaire: social-emotional development screening tool is used to assess children's (for age 2 month - 60 months) self-regulation, communication, autonomy, compliance, adaptive functioning, affect, and interaction with people.
Anthropometric Measurements	Baseline, Week 26/27 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	Participants will be measured for their height in feet and weight in kilograms. Weight and height will be combined to report BMI in kg/m\^2.
Blood pressure (BP)	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	Blood pressure will be measured using an automated blood pressure monitor.
Bioelectrical Impedance Analysis (BIA)	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	BIA is a non-invasive technology that can accurately measure a person's total body water, extracellular and intracellular fluid volumes.
Depression	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	Beck Depression Inventory II (BDI-II)
Health Status	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	The Short Form (36) Health Survey (SF-36)
Biosample Collection (Stool)	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	Stool collected via OMNIgene®•GUT OM-200 (Gut microbiota)
Anxiety	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	The State-Trait Anxiety Inventory (STAI)
Sleep	Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	PSQI: The Pittsburgh Sleep Quality Index (PSQI
Lifestyle	Baseline, Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)	e-Diary (Qualtrics survey system) self-report lifestyle

Trial Locations

Locations (1)

Singapore Institute for Clinical Sciences (SICS); 🇸🇬 Singapore, Singapore