An Exercise Intervention to Prevent Gestational Diabetes

An Exercise Intervention to Prevent Recurrent GDM

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Behavioral: Heath & Wellness; Behavioral: Physical activity

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.

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Batstate Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise	Behavioral: Physical activity; 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.
Active Comparator: Heath & Wellness	Behavioral: Heath & Wellness; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gestational diabetes diagnosis assessed through glucose tolerance test.	28 weeks gestational age

Secondary Outcome Measures

Outcome Measure	Time Frame
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
TNF-alpha	28 weeks gestational age
CRP	28 weeks gestational age
Birth weight	40 weeks gestational age
Apgar score	40 weeks gestational age
Adoption and maintenance of exercise during pregnancy	40 weeks gestational age

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Lisa Chasan-Taber, University of Massachusetts, Amherst

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: August 2, 2008
• First Submitted That Met QC Criteria: August 2, 2008
• First Posted (Estimate): August 5, 2008

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: physical activity; pregnancy; gestational diabetes; glucose tolerance; behavior change
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: DK74876; R01DK074876 (U.S. NIH Grant/Contract); 1R01DK074876-01A1 (U.S. NIH Grant/Contract)