Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes

NCT03324737 | Completed

• 1 other identifier: NMRC/HSRG/0071/2016
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Gestational diabetes (GDM) complicates about 20% of pregnancies in Singapore. These women are at high risk of developing type 2 diabetes years after pregnancy; seven times more likely than normal. Achieving a healthy weight post-delivery is key to reduce the risk of future diabetes. This study, from a multidisciplinary team, intends to create a unique seamless care model to restore optimal weight post-delivery in women with recent GDM. The innovation examined in this randomized control trial is an INTERACTIVE SMARTPHONE APP. The APP monitors weight, dietary habits, and exercise activity patterns, gives feedback, and provides practical personalized lifestyle coaching that is culturally appropriate and customized to the Singapore context. If efficacy is confirmed in this RCT, the APP can be easily scaled up as a cost-effective way to potentially prevent or delay the onset of type 2 diabetes in Singaporean women. Additionally, measurement of markers of cardiometabolic risk will give indications on future cardiovascular health, utilizing an underused opportunity to improve women's health.

Conditions

Gestational Diabetes; Weight Loss; Diet Habit

Keywords

Prevention; Smartphone application; Randomized control trial

Outcome Measures

Primary Outcomes (1)

• Weight at 4 months post-delivery

  Satisfactory weight is defined as return to weight at first booking visit (during 1st trimester) if booking BMI ≤23. If the booking weight is high (BMI\>23), the goal would be return to weight that is 5% lower than booking weight.

  4 months

Secondary Outcomes (9)

• Markers predictive of future type 2 diabetes and cardiometabolic risk

  4 months

• Dietary assessment

  4 months

• Subject's Self Efficacy to Regulate Exercise

  4 months

• Subject's Self Efficacy to Regulate Eating Habits

  4 months

• Subject's response to the research study using the Health Education Impact Questionnaire

  4 months

Study Arms (2)

Standard Care Arm

NO INTERVENTION

Subjects in the standard care arm will be informed of their increased risk of developing type 2 diabetes in the future, and given general lifestyle verbal advice to maintain a healthy weight, eat a well-balanced diet and do regular exercise during their 6 week postnatal visit. Women found to have impaired fasting glucose (6.1-6.9 mmol/L) or impaired glucose tolerance (2H post glucose of 7.8-11.0 mmol/L) will be issued a letter reinforcing lifestyle changes namely weight loss (if raised BMI), diet, exercise, and encouragement to consult a family physician to discuss the appropriateness of starting medications that can prevent the progression to type 2 diabetes, or restore the blood glucose to normal levels. Those with a normal OGTT result will just be informed that it is normal.

Interactive Smartphone App Arm

ACTIVE COMPARATOR

Participants will download the INTERACTIVE SMARTPHONE APP and will be briefed on its use by our team of nutritionists/dieticians, exercise physiologists and life style coaches. Weight: Participants will be reminded that the goal is satisfactory weight loss. NUH occupational therapist-trained lifestyle coaches, exercise physiotherapists, and clinical nutritionist/ dietician will interact with participants through real-time chats channels via the APP; all culturally appropriate and customized to the Singapore context.

Device: Interactive Smartphone App

Interventions

Interactive Smartphone App DEVICE

There are six main components to the APP. * Goal Setting: personalizes diet, activity, and weight loss goals for patients based on their starting point. * Food choices and recommendations: App has an automated and immediate recommendation of foods if the choice selected from food database is not optimal. It has a calorie and nutrients tracker to enable patients to track their food intake. * Activity and steps tracker: App has a pedometer to count physical activity and steps to enable patients to track their progress towards goals. * Interactive video lessons: App has video lessons pushed weekly to the patient according to her needs. The videos encompass aspects of diet, lifestyle and behavior management. * Healthcare Professionals Support: App has a chat channel to enable interaction between participants and healthcare professionals.

Interactive Smartphone App Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 21 years and above
• Plans to deliver in NUH
• Diagnosed with GDM antenatally (between 24-34 weeks gestation) defined using the 2013 World Health Organization criteria (fasting plasma glucose = 5.1 mmol/L, plasma glucose at 1H \<10 or plasma glucose at 2H post 75gm glucose load of =8.5 mmol/L)
• Has a smartphone and able to independently use a smartphone app
• Willing to provide a blood sample
• Able to give written informed consent
• Able to speak and read English

You may not qualify if:

• Subjects with type 1 and/or type 2 diabetes (including suspected cases diagnosed by an abnormal oral glucose tolerance test in the 1st and early 2nd trimesters of pregnancy)
• drugs that affect glucose or lipid metabolism (e.g. systemic steroids, metformin, insulin, statins, orlistat)
• terminal or life threatening condition
• physical or mental condition that would prevent completion of a majority of study instruments.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Related Publications (2)

• Lim K, Chan SY, Lim SL, Tai BC, Tsai C, Wong SR, Ang SM, Yew TW, Tai ES, Yong EL. A Smartphone App to Restore Optimal Weight (SPAROW) in Women With Recent Gestational Diabetes Mellitus: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Mar 16;9(3):e22147. doi: 10.2196/22147.

  PMID: 33724204 DERIVED

• Lim K, Chi C, Chan SY, Lim SL, Ang SM, Yoong JS, Tsai C, Wong SR, Yew TW, Tai ES, Yong EL. Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes. BMC Public Health. 2019 Oct 15;19(1):1287. doi: 10.1186/s12889-019-7691-3.

  PMID: 31615456 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Weight Loss; Feeding Behavior

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; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Eu Leong Yong

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The subjects who participate in the study may be seeing the doctors or allied health professionals involved in this study at the clinic. However, recruitment will not be done by them though they will help to improve the awareness of such a study to their patients. There will be no coercion involved as the subjects have the full autonomy to decide if they wish to participate.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective Randomized Control Trial will be conducted to compare an INTERACTIVE SMARTPHONE APP versus STANDARD care to optimize post-delivery weight in women with recent GDM. The aim is to reduce diabetes and cardiometabolic risk. During the antenatal period, subjects will be informed about the study during regular NUH nurse-led dietary counseling sessions. After delivery, women will be offered the opportunity to join the study. Informed consent will be obtained before discharge from hospital post-delivery. An appointment will be given for the first study visit at 6 weeks post-delivery.

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 30, 2017
• Study Start: November 16, 2017
• Primary Completion: June 7, 2019
• Study Completion: June 7, 2019
• Last Updated: August 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)