Randomized Clinical Trial of Lifestyle Interventions to Prevent Diabetes in Women With Previous Gestational Diabetes (LINDA-Brasil)

July 24, 2022 updated by: MSchmidt, Federal University of Rio Grande do Sul

Prevenção do Diabetes em Mulheres Com Diabetes Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil

Randomized trial aiming to investigate the effectiveness of a lifestyle intervention program implemented within the first year after a pregnancy complicated by gestational diabetes (GDM), in delaying or preventing the development of type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

LINDA-Brasil is a multicenter randomized clinical trial to test the effectiveness of a lifestyle intervention program tailored to women with a recent diagnosis of GDM to be implemented within two-year after pregnancy with the goal of preventing type 2 diabetes. It is based on a cohort study of women recruited during pregnancy. At first contact, the study protocol is explained, and it is made clear that not all women enrolled in the cohort will be eligible to participate in the post partum clinical trial. During pregnancy and the immediate post-partum period, women are monitored monthly by telephone to maintain contact. From six weeks to two years after delivery, high risk status is determined and women at high risk are contacted to evaluate their eligibility for the trial. Those potentially eligible are then invited to the research center for an examination prior to randomization. Once eligibility is confirmed, women return to the clinical research center at which point key aspects of the clinical trial protocol are reviewed and remaining questions clarified. Those willing to participate provide specific informed consent and are then allocated to one of the two comparison groups. The randomization scheme is 1:1 by trial arm, stratified by center and has random blocks. Based on results of key previous clinical trials on diabetes prevention, LINDA has tailored its intervention to meet the particular needs of women with previous GDM during their post partum. Building from social cognitive theory, interventions are participant-centered, allowing adaptation to each women´s setting, within the limits of a standardized prevention program with defined goals and structure. Communication strategies are based on motivational interviewing and health coaching approaches that can be implemented in the primary care setting. Follow-up is planned to continue until all women have completed at least 18 months of participation and the average length of follow up for the whole sample is at least three years. Outcomes are assessed at baseline, at 6 months and then annually. Women who develop diabetes will be notified and oriented to seek medical treatment.

Study Type

Interventional

Enrollment (Actual)

473

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60135-180
        • Centro de Estudos em Diabetes e Hipertensão
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96020-220
        • Federal University of Pelotas
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18 or older having gestational diabetes, regardless of the diagnostic criteria, who used insulin during their pregnancy or were found to have impaired glucose tolerance or impaired fasting glucose (>=100 mg/dL) on a post-partum oral glucose tolerance test (OGTT).
  • We amended the protocol to also include women using oral hypoglycemics during pregnancy because their use increased during the trial implementation.

Exclusion Criteria:

  • Confirmed postpartum diabetes (two abnormal OGTTs) or current use of antidiabetic medication
  • Indication that the trial interventions will not be feasible, for example, distance from the trial site
  • Poor attendance/response in previous contacts (appointments or phone interviews)
  • Health limitations or treatments (assessed by questionnaire) restricting the nutritional intervention or the ability to practice physical activity, affecting glucose tolerance or limiting participation or survival.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Promote and support healthy behaviors
Behavioral: Promote and support healthy behaviors
  • Exclusive breastfeeding for 6 months and partial breastfeeding for at least 3 additional months.
  • Personally monitored weight loss and maintenance with goal: return to pre-pregnancy weight and, if overweight pre-pregnancy, loss of an additional 5% of body weight.
  • Healthy eating: avoidance of ultra-processed foods, limited intake of oils, sugars and processed foods, increased intake of foodstuffs in their natural state, regular intake of water, dairy products, unsweetened coffee and tea.
  • A progressive increase in physical activity of at least 150 minutes of moderate or vigorous physical activity/week (7500 steps/day) and reduction of sedentary behavior with monitoring by personally worn devices.
No Intervention: Control
Conventional care for women with prior GDM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incident diabetes mellitus
Time Frame: Up to 5 years
Diabetes mellitus as ascertained by a 75g oral glucose tolerance test.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight at one year post randomization
Time Frame: 1 year

Return to pre-pregnancy weight; if overweight or obese before pregnancy, achieve an additional reduction of at least 5%;

Difference in weight determined between measured weight at 1 year post randomization and self-reported pre-pregnancy weight.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Eli Lilly and Company
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Pelotas
Fundação Médica do Rio Grande do Sul
Centro de Estudos em Diabetes e Hipertensão

Investigators

  • Principal Investigator: Maria I Schmidt, MD, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

December 29, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 24, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 563942/2010-0
  • U1111-1165-0608 (Registry Identifier: REBEC)
  • 00914312.0.1001.5327 (Registry Identifier: Plataforma Brasil)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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