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Ankle weights (2.5 pounds [1.1 kg]/ankle) for Gestational Diabetes (GDM Trial)

N/A
Waitlist Available
Led By Sarah Keim, PhD, MA, MS
Research Sponsored by Sarah Keim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18+ years
Diagnosed with GDM in current pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up nch visit 1 (25-35 days postpartum) to nch visit 2 (220-240 days postpartum)
Awards & highlights

GDM Trial Summary

This study is evaluating whether a simple activity-boosting intervention can help women with gestational diabetes lose weight.

Eligible Conditions
  • Gestational Diabetes

GDM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

GDM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~nch visit 1 (25-35 days postpartum) to nch visit 2 (220-240 days postpartum)
This trial's timeline: 3 weeks for screening, Varies for treatment, and nch visit 1 (25-35 days postpartum) to nch visit 2 (220-240 days postpartum) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight loss
Secondary outcome measures
BMI
Body Fat %
Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
+7 more

GDM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 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.
Group II: ControlPlacebo Group1 Intervention
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ankle weights (2.5 pounds [1.1 kg]/ankle)
2018
N/A
~80

Find a Location

Who is running the clinical trial?

Sarah KeimLead Sponsor
5 Previous Clinical Trials
955 Total Patients Enrolled
Ohio Department of HealthUNKNOWN
Ohio State UniversityOTHER
827 Previous Clinical Trials
502,676 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Physical Activity Intervention for Gestational Diabetes
Sarah Keim 2018. "Physical Activity Intervention for Gestational Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03664089.
~11 spots leftby Apr 2025
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