Gestational DiabetesNCT00728377
An Exercise Intervention to Prevent Gestational Diabetes
A study testing Physical activity and Heath & Wellness in people with Gestational Diabetes, run by University of Massachusetts, Amherst at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Physical activity and Heath & Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- history of gestational diabetes or overweight (>25 kg/m2) with family history of type 2 diabetes
- sedentary
Who cannot join
- 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
Show all 9Show fewer
- self-reported participation in >30 min of moderate or vigorous-intensity exercise on >3 days/wk
- prior participation in the study
- non-singleton pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Batstate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes
- Being tested
- Physical activity, Heath & Wellness
- Keywords
- gestational diabetes, physical activity, behavior change, glucose tolerance, pregnancy
- Medical subject headings
- Diabetes, Gestational, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
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.
Heath & WellnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Heath & Wellness | Active comparator | Not described Receives: Behavioral: Heath & Wellness |
| Exercise | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational diabetes diagnosis assessed through glucose tolerance test.
Measured: 28 weeks gestational age
Secondary outcomes (10)
Maternal weight gain
Measured: 40 weeks gestational age
Glucose
Measured: 28 weeks gestational age
Insulin
Measured: 28 weeks gestational age
Adiponectin
Measured: 28 weeks gestational age
Resistin
Measured: 28 weeks gestational age
TNF-alpha
Measured: 28 weeks gestational age
CRP
Measured: 28 weeks gestational age
Birth weight
Measured: 40 weeks gestational age
Apgar score
Measured: 40 weeks gestational age
Adoption and maintenance of exercise during pregnancy
Measured: 40 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionNov 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Chasan-Taber, University of Massachusetts, Amherst
- Investigators
- Lisa Chasan-Taber, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728377
- Sponsor's protocol ID
- DK74876
- Other IDs
- R01DK074876, 1R01DK074876-01A1
- Status last verified
- Oct 2016
- First submitted
- 2 Aug 2008
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25122031Hawkins 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.
PubMed 26104503Nobles 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.
PubMed 25932848Chasan-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.
PubMed 21918237
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exercise Intervention to Prevent Recurrent GDM
- ClinicalTrials.gov ID
- NCT00728377
- Acronym / sponsor ID
- DK74876
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, physical activity, behavior change, glucose tolerance, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heath & Wellness | Active comparator | Behavioral: Heath & Wellness |
| Exercise | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- history of gestational diabetes or overweight (>25 kg/m2) with family history of type 2 diabetes
- sedentary
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityIndividually 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. | Behavioural | Exercise |
| Heath & WellnessThe 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. | Behavioural | Heath & Wellness |
Primary outcome
Gestational diabetes diagnosis assessed through glucose tolerance test.
Time frame: 28 weeks gestational age
10 secondary outcomes
Maternal weight gain
Time frame: 40 weeks gestational age
Glucose
Time frame: 28 weeks gestational age
Insulin
Time frame: 28 weeks gestational age
Adiponectin
Time frame: 28 weeks gestational age
Resistin
Time frame: 28 weeks gestational age
TNF-alpha
Time frame: 28 weeks gestational age
CRP
Time frame: 28 weeks gestational age
Birth weight
Time frame: 40 weeks gestational age
Apgar score
Time frame: 40 weeks gestational age
Adoption and maintenance of exercise during pregnancy
Time frame: 40 weeks gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Background: PubMed 25122031Hawkins 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.
- Derived from this study: PubMed 26104503Hawkins 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.
- Derived from this study: PubMed 25932848Nobles 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.
- Derived from this study: PubMed 21918237Chasan-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.
Related trials for Gestational Diabetes
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Gestational Diabetes
Recruiting
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
Diabetes During Pregnancy
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Chasan-Taber principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Heath & Wellness in people with Gestational Diabetes, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes diagnosis assessed through glucose tolerance test. (time frame: 28 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00728377, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.