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

24. juli 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

473

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Promote and support healthy behaviors
Adfærdsmæssigt: 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.
Ingen indgriben: Control
Conventional care for women with prior GDM.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incident diabetes mellitus
Tidsramme: Up to 5 years
Diabetes mellitus as ascertained by a 75g oral glucose tolerance test.
Up to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight at one year post randomization
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of Rio Grande do Sul

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Maria I Schmidt, MD, PhD, Federal University of Rio Grande do Sul

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2015

Primær færdiggørelse (Faktiske)

31. marts 2022

Studieafslutning (Faktiske)

31. marts 2022

Datoer for studieregistrering

Først indsendt

23. december 2014

Først indsendt, der opfyldte QC-kriterier

29. december 2014

Først opslået (Skøn)

30. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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