NCT03559621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

April 14, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

4.1 years

First QC Date

May 23, 2018

Last Update Submit

September 14, 2023

Conditions

Gestational DiabetesType 2 Diabetes MellitusGlucose IntoleranceHealthy Lifestyle

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (22)

  • diabetes

    1 year

  • prediabetes

    6-16 weeks postpartum

  • prediabetes

    1 year postpartum

  • metabolic syndrome

    1 year

  • metabolic syndrome

    6-16 weeks postpartum

  • +17 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

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

OTHER

A mobile-based lifestyle intervention

Behavioral: mobile-based lifestyle intervention

Interventions

mobile-based lifestyle interventionBEHAVIORAL

one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed

intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

OLV Aalst-Asse

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

GZA

Antwerp, 2018, Belgium

Location

UZA

Antwerp, 2560, Belgium

Location

Imelda Bonheiden

Bonheiden, 2820, Belgium

Location

AZ Klina

Brasschaat, 2930, Belgium

Location

AZ Groeninge Kortrijk

Kortrijk, 8510, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Minschart C, Myngheer N, Maes T, De Block C, Van Pottelbergh I, Abrams P, Vinck W, Leuridan L, Driessens S, Mathieu C, Billen J, Matthys C, Laenen A, Bogaerts A, Benhalima K. Effectiveness of a blended mobile-based lifestyle intervention in women with glucose intolerance after a recent history of gestational diabetes (MELINDA): a 1-year, prospective, multicentre, randomised controlled trial. EClinicalMedicine. 2024 Mar 8;70:102523. doi: 10.1016/j.eclinm.2024.102523. eCollection 2024 Apr.

    PMID: 38495521DERIVED

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus, Type 2Glucose Intolerance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Officials

  • Katrien Benhalima, MD PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: RCT with a mobile based lifestyle intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 18, 2018

Study Start

April 14, 2019

Primary Completion

May 5, 2023

Study Completion

June 6, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(7)