NCT05949957Active, not recruiting
Harnessing Human Potential and Improving Health Span in Women and Their Children
Harnessing Human Potential and Improving Health Span in Women and Their Children: a Randomized Controlled Trial and Follow-up (HAPPY STUDY)
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 8 Jun 2023
- Start date
- 20 Oct 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Diseases
- Type 2 diabetes
- NCT number
- NCT05949957
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 20 Oct 2023 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous diagnosis of diabetes (Type 1 or 2), except GDM
- Experienced alcohol or drug abuse
- Currently participating in concurrent clinical trial or lifestyle intervention study
Other illness
- 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
Lab values
- Currently having medications known to influence glucose metabolism (e.g. peroral corticosteroids)
Other
- Currently pregnant
- Given birth within the last 12 weeks
- Severely limited mobility (e.g., wheelchair bound, require long-term walking aid, etc.)
Who the study is looking for
- 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
Age in the registry: 21 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Singapore Institute for Clinical Sciences (SICS) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.