A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT

NCT02588729 | Completed

• 1 other identifier: 38942
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will test a new way to communicate advice on diet and lifestyle to women with gestational diabetes mellitus by app downloaded on women's smartphone. The app wishes to motivate women to have a healthy diet, and be physically active. It allows automatic transfer of blood glucose measures from the glucose meter to the smartphone. The women will answer questionnaires during pregnancy and be followed up three months postpartum.

Conditions

Gestational Diabetes Mellitus

Keywords

Gestational diabetes; app; RCT; diet; physical activity

Outcome Measures

Primary Outcomes (1)

• Oral glucose tolerance test (OGTT), fasting and 2 hours blood glucose level after intake up til 75gr glucose (1.75gr/kg body weight)

  Part of routine care for women who had GDM, is an OGTT about three months postpartum, taken at their laboratory and reported to the investigators.Number of participants with level below 7.5 mmol

  Approximately three months after delivery.

Secondary Outcomes (13)

• complications of pregnancy

  Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum

• Dietary intake measured by "Fit for fødsel Food questionnaire"

  Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum

• Knowledge of gestational diabetes

  Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation

• Physical activity

  Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum

• Depression

  Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum

Study Arms (2)

Pregnant+ app for smartphone (Gravid+)

EXPERIMENTAL

The intervention consists of the Pregnant+app downloaded on women's smartphone. The app contains culturally adapted information about physical activity, diet and management of GDM. The Gravid+app will be available in Norwegain, Urdu and Somali. Women will have the opportunity to automatically transfer their blood glucose levels to their smartphones via Bluetooth.

Other: Pregnant+ app for smartphone

No admission to Pregnant+ app (Gravid+)

NO INTERVENTION

The control group will receive standard care at the outpatient departments. Participants to not receive the Pregnancy

Interventions

Pregnant+ app for smartphone OTHER

The Pregnant+app for smartphone with information about a healthy diet, physical activity and management of gestational diabetes mellitus.

Pregnant+ app for smartphone (Gravid+)

Eligibility Criteria

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

You may qualify if:

• First visit with gestational diabetes in this pregnancy
• Has her own smartphone
• Pregnancy up to 32 weeks and 6 days of gestation
• Fluent in Norwegian, Urdu or Somali
• Aged 18 years old and older

You may not qualify if:

• Pregnant with more than one fetus
• Lactose or gluten intolerance
• Known type 1 diabetes (insulin dependent)
• Known type 2 diabetes

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Universitetssenteret på Kjeller: collaborator
• Oslo University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• University Hospital, Akershus: collaborator
• The Norwegian Centre for Minority Health Research: collaborator

Study Sites (1)

Oslo university hospital

Oslo, 4950, Norway

Location

Related Publications (5)

• Garnweidner-Holme LM, Borgen I, Garitano I, Noll J, Lukasse M. Designing and Developing a Mobile Smartphone Application for Women with Gestational Diabetes Mellitus Followed-Up at Diabetes Outpatient Clinics in Norway. Healthcare (Basel). 2015 May 21;3(2):310-23. doi: 10.3390/healthcare3020310.

  PMID: 27417764 BACKGROUND

• Garnweidner-Holme L, Henriksen L, Bjerkan K, Lium J, Lukasse M. Factors associated with the level of physical activity in a multi-ethnic pregnant population - a cross-sectional study at the time of diagnosis with gestational diabetes. BMC Pregnancy Childbirth. 2022 Jan 3;22(1):1. doi: 10.1186/s12884-021-04335-x.

  PMID: 34979996 DERIVED

• Garnweidner-Holme L, Henriksen L, Torheim LE, Lukasse M. Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 4;8(11):e18614. doi: 10.2196/18614.

  PMID: 33146620 DERIVED

• Borgen I, Smastuen MC, Jacobsen AF, Garnweidner-Holme LM, Fayyad S, Noll J, Lukasse M. Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway. BMJ Open. 2019 Nov 11;9(11):e030884. doi: 10.1136/bmjopen-2019-030884.

  PMID: 31719080 DERIVED

• Borgen I, Garnweidner-Holme LM, Jacobsen AF, Bjerkan K, Fayyad S, Joranger P, Lilleengen AM, Mosdol A, Noll J, Smastuen MC, Terragni L, Torheim LE, Lukasse M. Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 Mar 27;7(3):e013117. doi: 10.1136/bmjopen-2016-013117.

  PMID: 28348183 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Alzheimer Disease; Motor Activity

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; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Mirjam Lukasse, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

NO (1)