- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03664089
Physical Activity Intervention for Gestational Diabetes (GDM)
July 19, 2022 updated by: Sarah Keim
Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM).
The increased risk associated with having GDM is compounded by excess weight retention.
Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM.
The long-term goal is to prevent T2DM among women with GDM.
This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM).
The increased risk associated with having GDM is compounded by excess weight retention, a common issue after any pregnancy.
Considering excess weight is the best predictor of developing T2DM, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM.
The long-term goal is to prevent T2DM among women with GDM.
This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM in a parallel two-arm randomized controlled trial (n=80 women/arm, N=160).
The intervention uses ankle weights (2.5 pounds [1.1 kg]) worn on each ankle during routine daily activities (e.g., cleaning, cooking, child care) to increase energy expenditure.
The central hypothesis, based on existing literature and preliminary data, is that postpartum women with GDM will adopt an intervention that requires minimal additional time outside of their daily activities.
We anticipate that this will result in additional weight loss that is clinically significant when compared with controls who only receive standard information on recommended physical activity.
The rationale for the proposed research is that once an intervention that both improves T2DM factors and is easily adopted by women with GDM is known, early intervention specific to this restricted timeframe can be implemented.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age 18+ years
- Diagnosed with GDM in current pregnancy
- English language ability adequate for participation
- Plan to remain in the area for study duration
- Ability to provide informed consent
Exclusion Criteria:
- Prior Type 1 or Type 2 diabetes
- Pregnant with multiples (e.g., twin, triplets, etc.)
- Premature infant [<35 completed weeks gestation (assessed after delivery, before randomization)]
- Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
- Pre-pregnancy BMI <18.5 (underweight)
- Live outside 35 mile radius of Ohio State University
- Woman is an appointed surrogate
- Infant will be adopted after delivery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week).
The weight type and weight amount were chosen based on previously published literature and used in our preliminary work.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
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Placebo Comparator: Control
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight loss
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Postpartum weight loss will be defined as weight change from initial weigh-in at NCH Visit 1 to final weigh-in at NCH Visit 2. Weight will be measured in person using the Tanita.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Fat %
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
|
Percent body fat will be defined as the change in initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Percent body fat will be measured in person using the Tanita.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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BMI
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
|
BMI will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. BMI will be measured using the Tanita for weight and obstetric medical record for height.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Waist-hip Ratio
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
|
Waist circumference (cm) will be assessed at the middle point between the ribs and the iliac crest, with the participant standing.
Hip circumference (cm) will be measured at the widest circumference of the buttocks.
Change in circumference will be defined as the change from initial measurement at NCH Visit 1 to final measurement at NCH Visit 2. Waist-hip ratio will be measured in person using metric cloth tape.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
A fasting 2-hour, 75g OGTT will be conducted during both NCH visits.
Glucose tolerance will be measured in mg/dL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Insulin sensitivity (β-cell function) will be measured using the Matsuda index and HOMA-IR.
Matsuda index score and HOMA-IR will be determined based on insulin values (μU/mL) and glucose values (mg/dL) obtained from the OGTT.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
|
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
HbA1c will be analyzed as a percentage.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
|
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Fasting serum leptin will be measured in ng/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
hsCRP will be measured in mg/L.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Adiponectin will be measured in µg/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Lipids will be analyzed including total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides.
Lipids will be measured in mg/dL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah Keim, PhD, MA, MS, Nationwide Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2018
Primary Completion (Actual)
February 22, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
September 5, 2018
First Submitted That Met QC Criteria
September 7, 2018
First Posted (Actual)
September 10, 2018
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 19, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-00178
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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