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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-14

Study Completion Date

2023-06-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Diabetes Type 2 Diabetes Mellitus Glucose Intolerance Healthy Lifestyle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

RCT with a mobile based lifestyle intervention

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

A mobile-based lifestyle intervention

Group Type OTHER

mobile-based lifestyle intervention

Intervention Type BEHAVIORAL

one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed

Interventions

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