Completed

Estudio PARTO: Proyecto pAra Reducir Diabetes Tipo dOs / Project Aiming to Reduce Type twO Diabetes

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What is being tested

Lifestyle Intervention

Behavioral
Who is being recruted

Endocrine System Diseases+2

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 45 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorUniversity of Massachusetts, Amherst
Last updated: April 29, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

Specific aims are to evaluate the impact of the intervention on 1) postpartum weight loss, 2) biomarkers associated with insulin resistance (i.e., glucose, insulin, HbA1c, leptin, TNF-α, HOMA, AUCgluc, adiponectin), 3) other cardiovascular risk factors (i.e., blood lipids, blood pressure, CRP, fetuin-A, albumin-to-creatinine ratio), and 4) the adoption and maintenance of postpartum behaviors associated with weight loss and prevention of diabetes risk (i.e., physical activity, diet). Eligible Hispanic women will be recruited after routine GDM screening and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) intervention (n=150). The intervention will be based on our efficacious exercise and dietary interventions for Hispanics (R01NR011295; WIC Common Pathways). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention from randomization (29 wks gestation) to 12 months postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for postpartum weight loss; American College of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and addresses the specific social, cultural, economic, and physical environmental challenges faced by underserved Hispanic women. Measures of adherence will include the Pregnancy Physical Activity Questionnaire (PPAQ), accelerometers, and dietary recalls. The project is a Renewal Application of R01 DK064902, a study of lifestyle risk factors for GDM in Hispanic women. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of lifestyle interventions among Hispanic pregnant women (R01 DK074876; S3948 ASPH/CDC) and controlled trials of lifestyle interventions among low-income Hispanics with type 2 diabetes and pre-diabetes (R18 DK0658850; R18DK067549) and can readily be translated into clinical practice in underserved and minority populations.

Principal SponsorUniversity of Massachusetts, Amherst
Last updated: April 29, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

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

263 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus

Criteria

1 inclusion criteria required to participate
Hispanic women with one or more glucose values during the diagnostic test meeting or exceeding the thresholds defined according to the American Diabetes Association

5 exclusion criteria prevent from participating
18 or > 45 yrs of age

contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis)

history of type 1 or type 2 diabetes, heart disease, or chronic renal disease

inability to read English or Spanish at a 6th grade level

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Stage-matched physical activity and diet intervention materials and health education.

Group II

No Intervention
HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Baystate Medical Center

Springfield, United StatesOpen Baystate Medical Center in Google Maps
CompletedOne Study Center