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

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ClinicalTrials.gov Identifier: NCT02327286
Recruitment Status : Recruiting
First Posted : December 30, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Eli Lilly and Company
Hospital de Clinicas de Porto Alegre
Fundação Médica do Rio Grande do Sul
Federal University of Pelotas
Centro de Estudos em Diabetes e Hipertensão
Information provided by (Responsible Party):
MSchmidt, Federal University of Rio Grande do Sul

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Diabetes, Gestational Behavioral: Promote and support healthy behaviors Phase 3

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  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevenção do Diabetes em Mulheres Com Diabetes Gestacional prévio: Estudo multicêntrico de mudanças Intensivas de Estilo de Vida: LINDA-Brasil
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Incident diabetes mellitus [ Time Frame: Up to 5 years ]
    Diabetes mellitus as ascertained by a 75g oral glucose tolerance test.


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327286


Contacts
Contact: Maria I Schmidt, MD, PhD +555133596302 maria.schmidt@ufrgs.br
Contact: Bruce B Duncan, MD, PhD +555133085347 bbduncan@ufrgs.br

Locations
Brazil
Centro de Estudos em Diabetes e Hipertensão Recruiting
Fortaleza, Ceará, Brazil, 60135-180
Contact: Adriana Costa e Forti, MD, PhD    85 3105 8300    adrianaforti@uol.com.br   
Contact: Cristina Façanha, MD, MSc    85 3105 8300    crisffacanha@hotmail.com   
Principal Investigator: Adriana Costa e Forti, MD, PhD         
Sub-Investigator: Cristina Façanha, MD, MSc         
Federal University of Pelotas Recruiting
Pelotas, Rio Grande do Sul, Brazil, 96020-220
Contact: Pedro C Hallal, PhD    53 3284 1300    prchallal@gmail.com   
Principal Investigator: Pedro C Hallal, PhD         
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Maria I Schmidt, MD, PhD    51 3359 6302    maria.schmidt@ufrgs.br   
Contact: Bruce B Duncan, MD, PhD    51 3359 6301    bbduncan@ufrgs.br   
Principal Investigator: Maria I Schmidt, MD, PhD         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Eli Lilly and Company
Hospital de Clinicas de Porto Alegre
Fundação Médica do Rio Grande do Sul
Federal University of Pelotas
Centro de Estudos em Diabetes e Hipertensão
Investigators
Principal Investigator: Maria I Schmidt, MD, PhD Federal University of Rio Grande do Sul

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSchmidt, Associate Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02327286     History of Changes
Other Study ID Numbers: 563942/2010-0
U1111-1165-0608 ( Registry Identifier: REBEC )
00914312.0.1001.5327 ( Registry Identifier: Plataforma Brasil )
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016

Keywords provided by MSchmidt, Federal University of Rio Grande do Sul:
Diabetes Mellitus
Gestational diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications