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

NCT02327286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2022-07-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Hospital de Clinicas de Porto Alegre

    collaborator OTHER

  • Fundação Médica do Rio Grande do Sul

    collaborator UNKNOWN

  • Federal University of Pelotas

    collaborator OTHER

  • Centro de Estudos em Diabetes e Hipertensão

    collaborator UNKNOWN

  • Federal University of Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Maria I Schmidt, MD, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02327286 on ClinicalTrials.gov