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

Study Overview
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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.

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

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

Intervention / Treatment
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* Behavioral: mobile-based lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: RCT with a mobile based lifestyle intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>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. | |
| Other: intervention group<br>A mobile-based lifestyle intervention | Behavioral: mobile-based lifestyle intervention<br>* one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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