search
Back to results

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

Primary Purpose

Gestational Diabetes, Type 2 Diabetes Mellitus, Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
mobile-based lifestyle intervention
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • OLV Aalst-Asse
  • GZA
  • UZA
  • Imelda Bonheiden
  • AZ Klina
  • AZ Groeninge Kortrijk
  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

control group

intervention group

Arm Description

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.

A mobile-based lifestyle intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2018
Last Updated
September 14, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
search

1. Study Identification

Unique Protocol Identification Number
NCT03559621
Brief Title
Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
Acronym
MELINDA
Official Title
Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2019 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Type 2 Diabetes Mellitus, Glucose Intolerance, Healthy Lifestyle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
RCT with a mobile based lifestyle intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
intervention group
Arm Type
Other
Arm Description
A mobile-based lifestyle intervention
Intervention Type
Behavioral
Intervention Name(s)
mobile-based lifestyle intervention
Intervention Description
one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed
Primary Outcome Measure Information:
Title
weight-loss goal
Description
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
Secondary Outcome Measure Information:
Title
diabetes
Description
development of type 2 diabetes based on the ADA criteria
Time Frame
1 year
Title
prediabetes
Description
prevalence of prediabetes based on the ADA criteria
Time Frame
6-16 weeks postpartum
Title
prediabetes
Description
prevalence of prediabetes based on the ADA criteria
Time Frame
1 year postpartum
Title
metabolic syndrome
Description
development of a metabolic syndrome based on the WHO criteria
Time Frame
1 year
Title
metabolic syndrome
Description
development of a metabolic syndrome based on the WHO criteria
Time Frame
6-16 weeks postpartum
Title
insulin resistance Matsuda
Description
insulin resistance measured by Matsuda index
Time Frame
1 year
Title
insulin resistance HOMA-IR
Description
insulin resistance measured by HOMA-IR
Time Frame
1 year
Title
beta-cell function ISSI-2 index
Description
beta-cell function measured by ISSI-2 index
Time Frame
1 year
Title
beta-cell function insulinogenic index
Description
beta-cell function measured by insulinogenic index
Time Frame
1 year
Title
beta-cell function HOMA-B
Description
beta-cell function measured by HOMA-B
Time Frame
1 year
Title
weight loss
Description
mean weight loss
Time Frame
1 year
Title
duration breastfeeding
Description
self-designed questionnaire to evaluate duration of breastfeeding
Time Frame
1 year
Title
rate exclusive breastfeeding
Description
self-designed questionnaire to evaluate rate of exclusive breastfeeding
Time Frame
1 year
Title
quality of life
Description
SF-36 questionnaire
Time Frame
1 year
Title
depression
Description
CES-D questionnaire
Time Frame
1 year
Title
anxiety
Description
STAI-6 questionnaire
Time Frame
1 year
Title
motivation for behavior change
Description
the TSRQ
Time Frame
1 year
Title
dietary quality
Description
Flemish FFQ
Time Frame
1 year
Title
physical activity IPAQ
Description
IPAQ questionnaire
Time Frame
1 year
Title
physical activity pedometer
Description
pedometer
Time Frame
1 year
Title
diabetes risk perception
Description
diabetes risk perception questionnaire
Time Frame
1 year
Title
Sence of Coherence
Description
Sence of Coherence (SOC) questionnaire
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrien Benhalima, MD PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLV Aalst-Asse
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Facility Name
GZA
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
UZA
City
Antwerpen
ZIP/Postal Code
2560
Country
Belgium
Facility Name
Imelda Bonheiden
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
AZ Groeninge Kortrijk
City
Kortrijk
ZIP/Postal Code
8510
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs