Clinical trial NCT00728377: An Exercise Intervention to Prevent Gestational Diabetes
Official title: An Exercise Intervention to Prevent Recurrent GDM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
physical activity
behavior change
glucose tolerance
pregnancy
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-08-05
Enrollment: 488
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The primary goals of the application are to investigate the effects of a motivationally-tailored, individually targeted 12-wk physical activity intervention on 1) risk of GDM in women at high risk of the condition, 2) serum biomarkers associated with insulin resistance, 3) and the adoption and maintenance of exercise during pregnancy. Secondary goals are to investigate the impact of the intervention on gestational weight gain and selected birth outcomes. The overall goal of the intervention is to encourage pregnant women to achieve the American College of Obstetricians and Gynecologists (ACOG) Guidelines for physical activity during pregnancy (30 minutes or more of moderate- intensity activity on most days of the week) through increasing walking and developing a more active lifestyle. The intervention draws from the theory of Stages of Motivational Readiness for Change and Social Cognitive Theory constructs for physical activity behavior and will take into account the specific social, cultural, economic, and physical environmental challenges faced by women of diverse socioeconomic and ethnic backgrounds. The application is innovative in being the first, to our knowledge, to test a physical activity intervention designed to prevent GDM among high risk women. The intervention protocol can readily be translated into clinical practice in underserved and minority populations.

Eligibility criteria: Inclusion Criteria:

* history of gestational diabetes or overweight (\>25 kg/m2) with family history of type 2 diabetes
* sedentary

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gestational diabetes diagnosis assessed through glucose tolerance test.
timeFrame: 28 weeks gestational age
Secondary outcomes:
measure: Maternal weight gain
timeFrame: 40 weeks gestational age
measure: Glucose
timeFrame: 28 weeks gestational age
measure: Insulin
timeFrame: 28 weeks gestational age
measure: Adiponectin
timeFrame: 28 weeks gestational age
measure: Resistin
timeFrame: 28 weeks gestational age
measure: TNF-alpha
timeFrame: 28 weeks gestational age
measure: CRP
timeFrame: 28 weeks gestational age
measure: Birth weight
timeFrame: 40 weeks gestational age
measure: Apgar score
timeFrame: 40 weeks gestational age
measure: Adoption and maintenance of exercise during pregnancy
timeFrame: 40 weeks gestational age
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Batstate Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Lisa Chasan-Taber
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hawkins 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.
citation: Nobles 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.
citation: Chasan-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.