Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
- Conditions
- Glucose IntoleranceHealthy LifestyleGestational DiabetesType 2 Diabetes Mellitus
- Interventions
- Behavioral: mobile-based lifestyle intervention
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- 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
- 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
- Arm && Interventions
Group Intervention Description intervention group mobile-based lifestyle intervention A mobile-based lifestyle intervention
- 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 beta-cell function HOMA-B 1 year beta-cell function measured by HOMA-B
physical activity IPAQ 1 year IPAQ questionnaire
Sence of Coherence 1 year Sence of Coherence (SOC) questionnaire
dietary quality 1 year Flemish FFQ
diabetes 1 year development of type 2 diabetes based on the ADA criteria
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
beta-cell function insulinogenic index 1 year beta-cell function measured by insulinogenic index
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
insulin resistance Matsuda 1 year insulin resistance measured by Matsuda 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
Trial Locations
- Locations (7)
GZA
🇧🇪Antwerpen, Belgium
UZA
🇧🇪Antwerpen, Belgium
AZ Groeninge Kortrijk
🇧🇪Kortrijk, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Imelda Bonheiden
🇧🇪Bonheiden, Belgium
AZ Klina
🇧🇪Brasschaat, Belgium
OLV Aalst-Asse
🇧🇪Aalst, Oost-Vlaanderen, Belgium