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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium
GZA
Antwerp, Belgium
UZA
Antwerp, Belgium
Imelda Bonheiden
Bonheiden, Belgium
AZ Klina
Brasschaat, Belgium
AZ Groeninge Kortrijk
Kortrijk, Belgium
UZ Leuven
Leuven, Belgium
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
Time frame: 1 year
diabetes
development of type 2 diabetes based on the ADA criteria
Time frame: 1 year
prediabetes
prevalence of prediabetes based on the ADA criteria
Time frame: 6-16 weeks postpartum
prediabetes
prevalence of prediabetes based on the ADA criteria
Time frame: 1 year postpartum
metabolic syndrome
development of a metabolic syndrome based on the WHO criteria
Time frame: 1 year
metabolic syndrome
development of a metabolic syndrome based on the WHO criteria
Time frame: 6-16 weeks postpartum
insulin resistance Matsuda
insulin resistance measured by Matsuda index
Time frame: 1 year
insulin resistance HOMA-IR
insulin resistance measured by HOMA-IR
Time frame: 1 year
beta-cell function ISSI-2 index
beta-cell function measured by ISSI-2 index
Time frame: 1 year
beta-cell function insulinogenic index
beta-cell function measured by insulinogenic index
Time frame: 1 year
beta-cell function HOMA-B
beta-cell function measured by HOMA-B
Time frame: 1 year
weight loss
mean weight loss
Time frame: 1 year
duration breastfeeding
self-designed questionnaire to evaluate duration of breastfeeding
Time frame: 1 year
rate exclusive breastfeeding
self-designed questionnaire to evaluate rate of exclusive breastfeeding
Time frame: 1 year
quality of life
SF-36 questionnaire
Time frame: 1 year
depression
CES-D questionnaire
Time frame: 1 year
anxiety
STAI-6 questionnaire
Time frame: 1 year
motivation for behavior change
the TSRQ
Time frame: 1 year
dietary quality
Flemish FFQ
Time frame: 1 year
physical activity IPAQ
IPAQ questionnaire
Time frame: 1 year
physical activity pedometer
pedometer
Time frame: 1 year
diabetes risk perception
diabetes risk perception questionnaire
Time frame: 1 year
Sence of Coherence
Sence of Coherence (SOC) questionnaire
Time frame: 1 year
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