Gestational Diabetes, Glucose Intolerance, Healthy Lifestyle, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
BEHAVIORALmobile-based lifestyle intervention
one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
RCT with a mobile based lifestyle intervention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| prediabetes | 6-16 weeks postpartum | prevalence of prediabetes based on the ADA criteria |
| metabolic syndrome | 1 year | development of a metabolic syndrome based on the WHO criteria |
| insulin resistance Matsuda | 1 year | insulin resistance measured by Matsuda index |
| 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 |
| beta-cell function insulinogenic index | 1 year | beta-cell function measured by insulinogenic index |
| beta-cell function HOMA-B | 1 year | beta-cell function measured by HOMA-B |
| weight loss | 1 year | mean weight loss |
| duration breastfeeding | 1 year | self-designed questionnaire to evaluate duration of breastfeeding |
| diabetes | 1 year | development of type 2 diabetes based on the ADA criteria |
| quality of life | 1 year | SF-36 questionnaire |
| depression | 1 year | CES-D questionnaire |
| anxiety | 1 year | STAI-6 questionnaire |
| motivation for behavior change | 1 year | the TSRQ |
| dietary quality | 1 year | Flemish FFQ |
| physical activity IPAQ | 1 year | IPAQ questionnaire |
| physical activity pedometer | 1 year | pedometer |
| diabetes risk perception | 1 year | diabetes risk perception questionnaire |
| Sence of Coherence | 1 year | Sence of Coherence (SOC) questionnaire |
| rate exclusive breastfeeding | 1 year | self-designed questionnaire to evaluate rate of exclusive breastfeeding |
Countries
Belgium
Outcome results
None listed