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An Exercise Intervention to Prevent Gestational Diabetes

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical activity
Heath & Wellness
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring gestational diabetes, physical activity, behavior change, glucose tolerance, pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Batstate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Heath & Wellness

Exercise

Arm Description

Outcomes

Primary Outcome Measures

Gestational diabetes diagnosis assessed through glucose tolerance test.

Secondary Outcome Measures

Maternal weight gain
Glucose
Insulin
Adiponectin
Resistin
TNF-alpha
CRP
Birth weight
Apgar score
Adoption and maintenance of exercise during pregnancy

Full Information

First Posted
August 2, 2008
Last Updated
October 24, 2016
Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00728377
Brief Title
An Exercise Intervention to Prevent Gestational Diabetes
Official Title
An Exercise Intervention to Prevent Recurrent GDM
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, physical activity, behavior change, glucose tolerance, pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heath & Wellness
Arm Type
Active Comparator
Arm Title
Exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Heath & Wellness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational diabetes diagnosis assessed through glucose tolerance test.
Time Frame
28 weeks gestational age
Secondary Outcome Measure Information:
Title
Maternal weight gain
Time Frame
40 weeks gestational age
Title
Glucose
Time Frame
28 weeks gestational age
Title
Insulin
Time Frame
28 weeks gestational age
Title
Adiponectin
Time Frame
28 weeks gestational age
Title
Resistin
Time Frame
28 weeks gestational age
Title
TNF-alpha
Time Frame
28 weeks gestational age
Title
CRP
Time Frame
28 weeks gestational age
Title
Birth weight
Time Frame
40 weeks gestational age
Title
Apgar score
Time Frame
40 weeks gestational age
Title
Adoption and maintenance of exercise during pregnancy
Time Frame
40 weeks gestational age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Chasan-Taber
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
Batstate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25122031
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.
Results Reference
background
PubMed Identifier
26104503
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.
Results Reference
derived
PubMed Identifier
25932848
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.
Results Reference
derived
PubMed Identifier
21918237
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.
Results Reference
derived

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An Exercise Intervention to Prevent Gestational Diabetes

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