- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05949957
Harnessing Human Potential and Improving Health Span in Women and Their Children (HAPPY)
Harnessing Human Potential and Improving Health Span in Women and Their Children: a Randomized Controlled Trial and Follow-up (HAPPY STUDY)
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johan Ericksson, MD
- Phone Number: 6516 4079/ 8938 7374
- Email: Johan_eriksson@sics.a-star.edu.sg
Study Contact Backup
- Name: Alicia Salamanca Sanabria, PhD
- Email: salamancas@sics.a-star.edu.sg
Study Locations
-
-
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Singapore, Singapore, 117549
- Recruiting
- Singapore Institute for Clinical Sciences (SICS)
-
Contact:
- Johan Eriksson, MD Prof
- Email: Johan_eriksson@sics.a-star.edu.sg
-
Contact:
- Alicia Salamanca-Sanabria, PhD
- Email: salamancas@sics.a-star.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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]). |
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).
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.
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
|
Active Comparator: Control group
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]). |
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Tolerance Changes
Time Frame: 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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure (BP)
Time Frame: 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.
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Depression
Time Frame: 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)
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Anxiety
Time Frame: 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)
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Health Status
Time Frame: 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)
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Sleep
Time Frame: 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
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Lifestyle
Time Frame: 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
|
Baseline, Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Anthropometric Measurements
Time Frame: 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.
|
Baseline, Week 26/27 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Biosample Collection (Fasting blood)
Time Frame: 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
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Biosample Collection (Saliva)
Time Frame: 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)
|
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)
Time Frame: 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)
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Biosample Collection (Stool)
Time Frame: 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)
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Bioelectrical Impedance Analysis (BIA)
Time Frame: 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.
|
Baseline, Week 26 (Midpoint Visit), Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Social-emotional development (Children)
Time Frame: 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.
|
Baseline, Year1, Year 2 (Follow-up 1), Year 3(Follow-up 2), Year 4(Follow-up 3)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Wellbeing
Time Frame: Baseline, Week 26 (Midpoint Visit), Year1
|
WHO-5 wellbeing Index
|
Baseline, Week 26 (Midpoint Visit), Year1
|
Infant sleep
Time Frame: Baseline, year 1
|
BISQ-R-SF: Brief infant sleep questionnaire is on parent-reported toddler (0-3 years) sleep over prior 1 week.
|
Baseline, year 1
|
Child and Mother Interaction
Time Frame: 12 months (Year 1 visit)
|
StimQ-toddler (for age 1-3 years) / StimQ-pre-school (for age 4-5 years) is designed to find out the different types of toys and games that mothers have for child in the home, and the kinds of activities that mother and child do together.
|
12 months (Year 1 visit)
|
Child's Sleep Habits
Time Frame: Baseline, year 1
|
CSHQ: Child's Sleep Habits Questionnaire (for age 4-5 years) assesses the frequency of children behaviors associated with common pediatric sleep difficulties.
|
Baseline, year 1
|
Cognitive emotion regulation strategies
Time Frame: Baseline, Week 26 (Midpoint Visit), Year1
|
CERQ: Cognitive Emotion Regulation Questionnaire
|
Baseline, Week 26 (Midpoint Visit), Year1
|
Sleep wake up
Time Frame: Baseline, Week 26 (Midpoint Visit), Year1
|
MEQ:The morningness-eveningness questionnaire
|
Baseline, Week 26 (Midpoint Visit), Year1
|
Happiness
Time Frame: Baseline, Week 26 (Midpoint Visit), Year1
|
SHS: Subjective Happiness Scale
|
Baseline, Week 26 (Midpoint Visit), Year1
|
Health Literacy
Time Frame: Baseline, Week 26 (Midpoint Visit), Year1
|
HLQ: Health Literacy Questionnaire
|
Baseline, Week 26 (Midpoint Visit), Year1
|
Stress
Time Frame: Baseline, Week 26 (Midpoint Visit), Year1
|
PSS-4: Perceived Stress Scale 4
|
Baseline, Week 26 (Midpoint Visit), Year1
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Moschonis G, Siopis G, Jung J, Eweka E, Willems R, Kwasnicka D, Asare BY, Kodithuwakku V, Verhaeghe N, Vedanthan R, Annemans L, Oldenburg B, Manios Y; DigiCare4You Consortium. Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials. Lancet Digit Health. 2023 Mar;5(3):e125-e143. doi: 10.1016/S2589-7500(22)00233-3.
- Castro O, Mair JL, Salamanca-Sanabria A, Alattas A, Keller R, Zheng S, Jabir A, Lin X, Frese BF, Lim CS, Santhanam P, van Dam RM, Car J, Lee J, Tai ES, Fleisch E, von Wangenheim F, Tudor Car L, Muller-Riemenschneider F, Kowatsch T. Development of "LvL UP 1.0": a smartphone-based, conversational agent-delivered holistic lifestyle intervention for the prevention of non-communicable diseases and common mental disorders. Front Digit Health. 2023 May 10;5:1039171. doi: 10.3389/fdgth.2023.1039171. eCollection 2023.
- Chen LW, Soh SE, Tint MT, Loy SL, Yap F, Tan KH, Lee YS, Shek LP, Godfrey KM, Gluckman PD, Eriksson JG, Chong YS, Chan SY. Combined analysis of gestational diabetes and maternal weight status from pre-pregnancy through post-delivery in future development of type 2 diabetes. Sci Rep. 2021 Mar 3;11(1):5021. doi: 10.1038/s41598-021-82789-x.
- Huebschmann AG, Huxley RR, Kohrt WM, Zeitler P, Regensteiner JG, Reusch JEB. Sex differences in the burden of type 2 diabetes and cardiovascular risk across the life course. Diabetologia. 2019 Oct;62(10):1761-1772. doi: 10.1007/s00125-019-4939-5. Epub 2019 Aug 27.
- Moon JH, Kwak SH, Jang HC. Prevention of type 2 diabetes mellitus in women with previous gestational diabetes mellitus. Korean J Intern Med. 2017 Jan;32(1):26-41. doi: 10.3904/kjim.2016.203. Epub 2017 Jan 1.
- Rayanagoudar G, Hashi AA, Zamora J, Khan KS, Hitman GA, Thangaratinam S. Quantification of the type 2 diabetes risk in women with gestational diabetes: a systematic review and meta-analysis of 95,750 women. Diabetologia. 2016 Jul;59(7):1403-1411. doi: 10.1007/s00125-016-3927-2. Epub 2016 Apr 13.
- Vounzoulaki E, Khunti K, Abner SC, Tan BK, Davies MJ, Gillies CL. Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis. BMJ. 2020 May 13;369:m1361. doi: 10.1136/bmj.m1361.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/00178 (Other Identifier: Singapore Institute for Clinical Sciences (SICS))
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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