Clinical trial NCT03559621: Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
Official title: Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Type 2 Diabetes Mellitus
Glucose Intolerance
Healthy Lifestyle
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: RCT with a mobile based lifestyle intervention
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: weight-loss goal
timeFrame: 1 year
Secondary outcomes:
measure: diabetes
timeFrame: 1 year
measure: prediabetes
timeFrame: 6-16 weeks postpartum
measure: prediabetes
timeFrame: 1 year postpartum
measure: metabolic syndrome
timeFrame: 1 year
measure: metabolic syndrome
timeFrame: 6-16 weeks postpartum
measure: insulin resistance Matsuda
timeFrame: 1 year
measure: insulin resistance HOMA-IR
timeFrame: 1 year
measure: beta-cell function ISSI-2 index
timeFrame: 1 year
measure: beta-cell function insulinogenic index
timeFrame: 1 year
measure: beta-cell function HOMA-B
timeFrame: 1 year
measure: weight loss
timeFrame: 1 year
measure: duration breastfeeding
timeFrame: 1 year
measure: rate exclusive breastfeeding
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
measure: depression
timeFrame: 1 year
measure: anxiety
timeFrame: 1 year
measure: motivation for behavior change
timeFrame: 1 year
measure: dietary quality
timeFrame: 1 year
measure: physical activity IPAQ
timeFrame: 1 year
measure: physical activity pedometer
timeFrame: 1 year
measure: diabetes risk perception
timeFrame: 1 year
measure: Sence of Coherence
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst-Asse
state: Oost-Vlaanderen
city: Antwerpen
country: Belgium
facility: GZA
city: Antwerpen
country: Belgium
facility: UZA
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Katrien Benhalima, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: