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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle)
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.
Placebo Comparator: Control
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
Behavioral: Control
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. hsCRP will be measured in mg/L.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Adiponectin will be measured in µg/mL.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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)
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.
NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sarah Keim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ohio State University
American Diabetes Association
Ohio Department of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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