Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 240
- Locations
- 7
- Primary Endpoint
- weight-loss goal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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.
intervention group
A mobile-based lifestyle intervention
Intervention: mobile-based lifestyle intervention (Behavioral)
Outcomes
Primary Outcomes
weight-loss goal
Time Frame: 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 Outcomes
- prediabetes(1 year postpartum)
- insulin resistance HOMA-IR(1 year)
- dietary quality(1 year)
- diabetes(1 year)
- metabolic syndrome(6-16 weeks postpartum)
- duration breastfeeding(1 year)
- rate exclusive breastfeeding(1 year)
- depression(1 year)
- Sence of Coherence(1 year)
- beta-cell function ISSI-2 index(1 year)
- beta-cell function insulinogenic index(1 year)
- insulin resistance Matsuda(1 year)
- beta-cell function HOMA-B(1 year)
- weight loss(1 year)
- quality of life(1 year)
- anxiety(1 year)
- motivation for behavior change(1 year)
- physical activity IPAQ(1 year)
- diabetes risk perception(1 year)
- physical activity pedometer(1 year)
- prediabetes(6-16 weeks postpartum)
- metabolic syndrome(1 year)