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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

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

Treatments: Behavioral: mobile-based lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03559621

the Melinda study

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

control group

No Intervention group

Description:

Women in the control group will receive follow-up as in normal routine with referral to primary care. They will receive an OGTT after 1 year as part of the trial.

intervention group

Other group

Description:

A mobile-based lifestyle intervention

Treatment:

Behavioral: mobile-based lifestyle intervention