Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— MELINDA  

Official title:

Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559621
• Other study ID #: the Melinda study
• Status: Completed
• Phase: N/A
• Start date: April 14, 2019
• Est. completion date: June 6, 2023

Study information

• Verified date: September 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. The low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. Since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (T2DM), we designed the MELINDA pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of GDM to promote a healthy lifestyle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 6, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 or older
• GDM based on the 2013 WHO criteria
• glucose intolerance (prediabetes based on the ADA criteria) based on the 75g OGTT 6-16 weeks after delivery

Exclusion Criteria:

• diabetes;
• current use of metformin;
• normal glucose tolerance (ADA criteria);
• health limitations or treatments which would restrict the participation in the intervention trial.
• Has no smartphone

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Healthy Lifestyle
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• mobile-based lifestyle intervention
one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed

Locations

Country	Name	City	State
Belgium	OLV Aalst-Asse	Aalst	Oost-Vlaanderen
Belgium	GZA	Antwerpen
Belgium	UZA	Antwerpen
Belgium	Imelda Bonheiden	Bonheiden
Belgium	AZ Klina	Brasschaat
Belgium	AZ Groeninge Kortrijk	Kortrijk
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight-loss goal	reaching the weight-loss goal =5% of body weight when overweight or obese or returning to pre-gravid weight if normal BMI	1 year
Secondary	diabetes	development of type 2 diabetes based on the ADA criteria	1 year
Secondary	prediabetes	prevalence of prediabetes based on the ADA criteria	6-16 weeks postpartum
Secondary	prediabetes	prevalence of prediabetes based on the ADA criteria	1 year postpartum
Secondary	metabolic syndrome	development of a metabolic syndrome based on the WHO criteria	1 year
Secondary	metabolic syndrome	development of a metabolic syndrome based on the WHO criteria	6-16 weeks postpartum
Secondary	insulin resistance Matsuda	insulin resistance measured by Matsuda index	1 year
Secondary	insulin resistance HOMA-IR	insulin resistance measured by HOMA-IR	1 year
Secondary	beta-cell function ISSI-2 index	beta-cell function measured by ISSI-2 index	1 year
Secondary	beta-cell function insulinogenic index	beta-cell function measured by insulinogenic index	1 year
Secondary	beta-cell function HOMA-B	beta-cell function measured by HOMA-B	1 year
Secondary	weight loss	mean weight loss	1 year
Secondary	duration breastfeeding	self-designed questionnaire to evaluate duration of breastfeeding	1 year
Secondary	rate exclusive breastfeeding	self-designed questionnaire to evaluate rate of exclusive breastfeeding	1 year
Secondary	quality of life	SF-36 questionnaire	1 year
Secondary	depression	CES-D questionnaire	1 year
Secondary	anxiety	STAI-6 questionnaire	1 year
Secondary	motivation for behavior change	the TSRQ	1 year
Secondary	dietary quality	Flemish FFQ	1 year
Secondary	physical activity IPAQ	IPAQ questionnaire	1 year
Secondary	physical activity pedometer	pedometer	1 year
Secondary	diabetes risk perception	diabetes risk perception questionnaire	1 year
Secondary	Sence of Coherence	Sence of Coherence (SOC) questionnaire	1 year