An Exercise Intervention to Prevent Gestational Diabetes
3 other identifiers
interventional
488
1 country
1
Brief Summary
Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and thus provides an excellent opportunity to intervene years before the development of this disorder. It is well recognized that acute as well as chronic physical activity reduce fasting plasma glucose as well as improve glucose tolerance in type 2 diabetes. Recent studies have suggested that women with higher levels of physical activity have reduced risk of GDM. Therefore, we will test the hypothesis that an exercise intervention is an effective tool for preventing GDM among women with a history of GDM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 2, 2008
CompletedFirst Posted
Study publicly available on registry
August 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedOctober 26, 2016
October 1, 2016
4.3 years
August 2, 2008
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gestational diabetes diagnosis assessed through glucose tolerance test.
28 weeks gestational age
Secondary Outcomes (10)
Maternal weight gain
40 weeks gestational age
Glucose
28 weeks gestational age
Insulin
28 weeks gestational age
Adiponectin
28 weeks gestational age
Resistin
28 weeks gestational age
- +5 more secondary outcomes
Study Arms (2)
Heath & Wellness
ACTIVE COMPARATORExercise
EXPERIMENTALInterventions
Individually Tailored (IT) Exercise Intervention This intervention is designed to increase the amount of physical activity incorporated into the daily lifestyle of pregnant women, primarily through increased walking, with the ultimate goal of achieving the American College of Obstetricians and Gynecologists (ACOG) exercise goals for pregnant women. These goals are the same as the Surgeon General's Guidelines for physical activity for nonpregnant individuals (30 minutes or more or moderate activity on most days of the week).The intervention includes: 1) individually tailored print-based materials (i.e., individually-tailored reports and stage-matched manuals), 2) self-monitoring materials, and 3) goal setting.
The comparison intervention consists of a series of informational booklets published by the American College of Obstetricians and Gynecologists on general issues related to health and wellness during pregnancy. These include alcohol and drug use during pregnancy, easing back pain, as well as the Pregnancy Fitness brochure on the safety of exercise during pregnancy. These booklets are selected to represent high-quality, standard, low-cost, self-help material currently available to the public.
Eligibility Criteria
You may qualify if:
- history of gestational diabetes or overweight (\>25 kg/m2) with family history of type 2 diabetes
- sedentary
You may not qualify if:
- history of diagnosis of diabetes, hypertension, heart disease or chronic renal disease
- current medications which adversely influence glucose tolerance
- not planning to continue the pregnancy to term
- \>16 weeks gestation
- contraindications to participating in moderate physical activity
- inability to read English at a 6th grade level
- self-reported participation in \>30 min of moderate or vigorous-intensity exercise on \>3 days/wk
- prior participation in the study
- non-singleton pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Batstate Medical Center
Springfield, Massachusetts, 01199, United States
Related Publications (4)
Hawkins M, Chasan-Taber L, Marcus B, Stanek E, Braun B, Ciccolo J, Markenson G. Impact of an exercise intervention on physical activity during pregnancy: the behaviors affecting baby and you study. Am J Public Health. 2014 Oct;104(10):e74-81. doi: 10.2105/AJPH.2014.302072. Epub 2014 Aug 14.
PMID: 25122031BACKGROUNDHawkins M, Braun B, Marcus BH, Stanek E 3rd, Markenson G, Chasan-Taber L. The impact of an exercise intervention on C - reactive protein during pregnancy: a randomized controlled trial. BMC Pregnancy Childbirth. 2015 Jun 24;15:139. doi: 10.1186/s12884-015-0576-2.
PMID: 26104503DERIVEDNobles C, Marcus BH, Stanek EJ 3rd, Braun B, Whitcomb BW, Solomon CG, Manson JE, Markenson G, Chasan-Taber L. Effect of an exercise intervention on gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1195-1204. doi: 10.1097/AOG.0000000000000738.
PMID: 25932848DERIVEDChasan-Taber L, Silveira M, Marcus BH, Braun B, Stanek E, Markenson G. Feasibility and efficacy of a physical activity intervention among pregnant women: the behaviors affecting baby and you (B.A.B.Y.) study. J Phys Act Health. 2011 Sep;8 Suppl 2(0 2):S228-38.
PMID: 21918237DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Chasan-Taber
University of Massachusetts, Amherst
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 2, 2008
First Posted
August 5, 2008
Study Start
July 1, 2007
Primary Completion
November 1, 2011
Study Completion
November 1, 2012
Last Updated
October 26, 2016
Record last verified: 2016-10