Randomized Clinical Trial of Lifestyle Interventions to Prevent Diabetes in Women With Previous Gestational Diabetes

NCT02327286 | Completed

• 3 other identifiers: 563942/2010-0U1111-1165-060800914312.0.1001.5327
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus; Diabetes, Gestational

Keywords

Diabetes Mellitus; Gestational diabetes

Outcome Measures

Primary Outcomes (1)

• Incident diabetes mellitus

  Diabetes mellitus as ascertained by a 75g oral glucose tolerance test.

  Up to 5 years

Secondary Outcomes (1)

• Weight at one year post randomization

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Promote and support healthy behaviors

Behavioral: Promote and support healthy behaviors

Control

NO INTERVENTION

Conventional care for women with prior GDM.

Interventions

Promote and support healthy behaviors BEHAVIORAL

* 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Centro de Estudos em Diabetes e Hipertensão

Fortaleza, Ceará, 60135-180, Brazil

Location

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96020-220, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (3)

• Schmidt MI, Duncan BB, Castilhos C, Wendland EM, Hallal PC, Schaan BD, Drehmer M, Costa E Forti A, Facanha C, Nunes MA. Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial. BMC Pregnancy Childbirth. 2016 Mar 30;16:68. doi: 10.1186/s12884-016-0851-x.

  PMID: 27029489 BACKGROUND

• Schmidt MI, Bracco PA, Nunes MA, Cherubini KA, Castilhos CD, Spagiari JZ, Galliano LM, Ladwig R, Del Vecchio FB, Del Vecchio AHM, Drehmer M, Forti AC, Facanha C, Zajdenverg L, de Almeida-Pititto B, Rea RR, Dualib PM, Duncan BB. Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial. BMJ Open. 2024 Oct 15;14(10):e082572. doi: 10.1136/bmjopen-2023-082572.

  PMID: 39414286 DERIVED

• Dame P, Cherubini K, Goveia P, Pena G, Galliano L, Facanha C, Nunes MA. Depressive Symptoms in Women with Gestational Diabetes Mellitus: The LINDA-Brazil Study. J Diabetes Res. 2017;2017:7341893. doi: 10.1155/2017/7341893. Epub 2017 Jun 8.

  PMID: 28685151 DERIVED

Related Links

• Study protocol

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Maria I Schmidt, MD, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: January 1, 2015
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

BR (3)