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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Glucose Intolerance; Gestational Diabetes; Healthy Lifestyle
• Intervention / Treatment: Behavioral: mobile-based lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrien Benhalima, MD PhD; Phone Number: 032 16340614; Email: katrien.benhalima@uzleuven.be

Study Locations

• Belgium
  • Antwerpen, Belgium, 2560
    • UZA
  • Antwerpen, Belgium, 2018
    • GZA
  • Bonheiden, Belgium, 2820
    • Imelda Bonheiden
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Kortrijk, Belgium, 8510
    • AZ Groeninge Kortrijk
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • OLV Aalst-Asse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Other: intervention group; A mobile-based lifestyle intervention	Behavioral: mobile-based lifestyle intervention; one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
diabetes	development of type 2 diabetes based on the ADA criteria	1 year
prediabetes	prevalence of prediabetes based on the ADA criteria	6-16 weeks postpartum
prediabetes	prevalence of prediabetes based on the ADA criteria	1 year postpartum
metabolic syndrome	development of a metabolic syndrome based on the WHO criteria	1 year
metabolic syndrome	development of a metabolic syndrome based on the WHO criteria	6-16 weeks postpartum
insulin resistance Matsuda	insulin resistance measured by Matsuda index	1 year
insulin resistance HOMA-IR	insulin resistance measured by HOMA-IR	1 year
beta-cell function ISSI-2 index	beta-cell function measured by ISSI-2 index	1 year
beta-cell function insulinogenic index	beta-cell function measured by insulinogenic index	1 year
beta-cell function HOMA-B	beta-cell function measured by HOMA-B	1 year
weight loss	mean weight loss	1 year
duration breastfeeding	self-designed questionnaire to evaluate duration of breastfeeding	1 year
rate exclusive breastfeeding	self-designed questionnaire to evaluate rate of exclusive breastfeeding	1 year
quality of life	SF-36 questionnaire	1 year
depression	CES-D questionnaire	1 year
anxiety	STAI-6 questionnaire	1 year
motivation for behavior change	the TSRQ	1 year
dietary quality	Flemish FFQ	1 year
physical activity IPAQ	IPAQ questionnaire	1 year
physical activity pedometer	pedometer	1 year
diabetes risk perception	diabetes risk perception questionnaire	1 year
Sence of Coherence	Sence of Coherence (SOC) questionnaire	1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Katrien Benhalima, MD PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2019
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hyperglycemia; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance; Diabetes, Gestational
• Other Study ID Numbers: the Melinda study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No