A Mobile Health-enabled Lifestyle Intervention Among Women With History of Gestational Diabetes(GDM)

NCT05512871 | Completed DMC

• 1 other identifier: 2021/00843
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore: (1) the relationship between lifestyle factors (eating, movement behaviour, sleep and stress) and glycaemic profile, and (2) the feasibility of delivering lifestyle intervention through the proposed mHealth strategy.

Conditions

Healthy; Gestational Diabetes Mellitus in Pregnancy; Diabetes, Gestational

Keywords

Healthy women, Gestational Diabetes Mellitus history, GDM history, mobile health apps

Outcome Measures

Primary Outcomes (1)

• Mobile health application feasibility

  Number of participants that show a change in lifestyle behaviour through the mobile health application usage.

  10 weeks

Secondary Outcomes (8)

• Oral glucose tolerance test (OGTT) measurements

  Week -1 and 10

• Change in sleep quality as assessed by the Oura Ring Sleep Score.

  10 weeks

• Change in daily physical activity levels as assessed by the Oura Ring Activity Score.

  10 weeks

• Postprandial glucose

  14 days

• Change in quality of life

  Week -1 and 10

Study Arms (2)

Group 1 (Intervention group)

EXPERIMENTAL

Group 1 (Intervention group) :Oura ring with Oura App + HealthifySG App (receive lifestyle interventions via HealthifySG App)

Behavioral: Personalized mHealth intervention to promote short-term metabolic and mental health among women with a history of Gestational Diabetes Mellitus (GDM)

Group 2 (Control group)

OTHER

Group 2 (Control group) : Oura ring with Oura App alone (without lifestyle interventions)

Behavioral: Personalized mHealth intervention to promote short-term metabolic and mental health among women with a history of Gestational Diabetes Mellitus (GDM)

Interventions

Personalized mHealth intervention to promote short-term metabolic and mental health among women with a history of Gestational Diabetes Mellitus (GDM) BEHAVIORAL

The study aim to conduct lifestyle intervention trials to examine the feasibility, efficacy, and cost-effectiveness of the mHealth approach in preventing them from developing Type 2 Diabetes in the future. This pilot study will primarily aim to determine the feasibility of our intervention approaches as well as enhance health literacy and promote healthy lifestyle in the study participants. In the longer term, we hope that the proposed mHealth intervention can be translated to include women from the community setting and involve wider healthcare setting to come together and reduce the burden of Type 2 Diabetes in Singapore.

Group 1 (Intervention group); Group 2 (Control group)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Healthy women volunteers who has given birth previously and with a history of GDM within the last 5 years (Post partum 13 weeks and beyond).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers (age 21-45 years)
• A history of GDM in the past 5 years
• Not planning to conceive during the study period
• Not performing full breastfeeding during the study period
• Own a smart phone(mobile phone) compatible with study App (Android v10 and above)
• Proficient in English language
• Plan to stay in Singapore for the next 1 year
• Willing to comply to study protocol
• Able to provide a written informed consent

You may not qualify if:

• Current and/or previous diagnosis of diabetes except GDM
• Currently pregnant
• Given birth within last 12 weeks
• Following special diet or dietary restriction
• Experiencing severely limited mobility (e.g. wheelchair bound, need walking aid etc.)
• Diagnosed with malnutrition, eating disorder, severe insomnia
• Diagnosed with cancers, unstable heart related diseases, severe kidney disease
• Diagnosed with severe unstable mental conditions, dementia or cognitive impairment
• Alcohol or drug abuse
• Medications known to influence glucose metabolism e.g. peroral corticosteroids

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• National University Polyclinics, Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Human Development Research Centre (Hdrc)

Singapore, 117597, Singapore

Location

Related Publications (1)

• Liew SJ, Soon CS, Chooi YC, Tint MT, Eriksson JG. A holistic approach to preventing type 2 diabetes in Asian women with a history of gestational diabetes mellitus: a feasibility study and pilot randomized controlled trial. Front Clin Diabetes Healthc. 2023 Sep 28;4:1251411. doi: 10.3389/fcdhc.2023.1251411. eCollection 2023.

  PMID: 37841647 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 60-80 female subjects will be randomized to either Group 1 (Intervention group) or Group 2 (Control group) based on 1:1 allocation. HealthifySG App will only be installed on the phones of subjects for Group 1(Intervention group).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director & Programme Director (Human Development)

Model Details: The study is a parallel 2-arm, single-centre randomized controlled trial based on 1:1 allocation ratio: Group1 (Intervention group) - Oura ring with Oura App + HealthifySG App (receive lifestyle interventions via HealthifySG App) Group 2 (Control group) - Oura ring with Oura App alone (without lifestyle interventions)

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 23, 2022
• Study Start: September 19, 2022
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)