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

Not Applicable

Completed

• Conditions: Glucose Intolerance; Healthy Lifestyle; Gestational Diabetes; Type 2 Diabetes Mellitus

• Registration Number: NCT03559621
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-06-05
• Study First Posted: 2018-06-18
• Study Start: 2019-04-14
• Primary Completion: 2023-05-05
• Study Completion: 2023-06-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
weight-loss goal	1 year	reaching the weight-loss goal ≥5% of body weight when overweight or obese or returning to pre-gravid weight if normal BMI

Secondary Outcome Measures

Name	Time	Method
dietary quality	1 year	Flemish FFQ
metabolic syndrome	6-16 weeks postpartum	development of a metabolic syndrome based on the WHO criteria
duration breastfeeding	1 year	self-designed questionnaire to evaluate duration of breastfeeding
rate exclusive breastfeeding	1 year	self-designed questionnaire to evaluate rate of exclusive breastfeeding
depression	1 year	CES-D questionnaire
prediabetes	1 year postpartum	prevalence of prediabetes based on the ADA criteria
insulin resistance HOMA-IR	1 year	insulin resistance measured by HOMA-IR
beta-cell function ISSI-2 index	1 year	beta-cell function measured by ISSI-2 index
beta-cell function insulinogenic index	1 year	beta-cell function measured by insulinogenic index
weight loss	1 year	mean weight loss
quality of life	1 year	SF-36 questionnaire
anxiety	1 year	STAI-6 questionnaire
motivation for behavior change	1 year	the TSRQ
diabetes risk perception	1 year	diabetes risk perception questionnaire
physical activity pedometer	1 year	pedometer
Sence of Coherence	1 year	Sence of Coherence (SOC) questionnaire
beta-cell function HOMA-B	1 year	beta-cell function measured by HOMA-B
physical activity IPAQ	1 year	IPAQ questionnaire
diabetes	1 year	development of type 2 diabetes based on the ADA criteria
insulin resistance Matsuda	1 year	insulin resistance measured by Matsuda index

Trial Locations

Locations (7)

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, Belgium