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Physical Activity Intervention for Gestational Diabetes (GDM)

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ClinicalTrials.gov Identifier: NCT03664089
Recruitment Status : Enrolling by invitation
First Posted : September 10, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Ohio Department of Health
Ohio State University
American Diabetes Association
Information provided by (Responsible Party):
Sarah Keim, Nationwide Children's Hospital

Brief Summary:
Gestational diabetes mellitus (GDM) portends immediate, increased risk for both type 2 diabetes mellitus (T2DM). These increased risks are 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 and/or delay T2DM.Our long-term goal is to prevent T2DM among women with GDM. The objective here is to evaluate the efficacy of a simple, novel, activity-boosting intervention on weight loss among women with GDM.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle) Behavioral: Control Not Applicable

Detailed Description:
Gestational diabetes mellitus (GDM) portends immediate, increased risk for both type 2 diabetes mellitus (T2DM). These increased risks are 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 and/or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. The objective here is to evaluate the efficacy of a simple, novel, 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, etc.)) 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, resulting in more and clinically significant weight loss compared with controls who only receive standard information on recommended physical activity. The rationale for the proposed research is that once an intervention that women with GDM will adopt and improves T2DM risk factors is known, early intervention specific to this restricted time can be implemented.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Activity Intervention for Gestational Diabetes
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 previous published work and 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), instructions on ankle weight usage and the corresponding stopwatch function on the accelerometer to document 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.




Primary Outcome Measures :
  1. Weight loss [ Time Frame: Homevisit (7-14 days postpartum) to NCH Visit 2 (220-240 days postpartum) ]
    Postpartum weight loss will be defined as weight change from initial weigh-in at the home visit to final weigh-in at NCH visit 2. Weight will be measured in person using the Tanita.


Secondary Outcome Measures :
  1. Body Fat % [ Time Frame: Homevisit (7-14 days postpartum) to NCH Visit 2 (220-240 days postpartum) ]
    Percent body fat will be defined change in initial measurement at the home visit to final measurement at NCH visit 2. Percent body fat will be measured in person using the Tanita.

  2. BMI [ Time Frame: Homevisit (7-14 days postpartum) to NCH Visit 2 (220-240 days postpartum) ]
    BMI will be defined as change from initial measurement at the home visit to final measurement at NCH visit 2. Percent body fat will be measured in person using the Tanita.

  3. Waist-hip Ratio [ Time Frame: Homevisit (7-14 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 ileac 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 change from initial measurement at the home visit to final measurement at NCH visit 2. Percent body fat will be measured in person using the Tanita.

  4. Gylcemia 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 two visits to 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.

  5. Gylcemia 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 two visits to 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/L) obtained from the OGTT.

  6. Gylcemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c [ Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum) ]
    Blood will be collected during two visits to NCH and sent to the NCH lab for analysis. Hemoglobin A1c will be analyzed as a percentage.

  7. Gylcemia 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 two visits to NCH and sent to the NCH lab for analysis. Fasting serum leptin will be measured in ng/ml.

  8. Gylcemia 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 two visits to NCH and sent to the NCH lab for analysis. Hs-CRP will be measured in mg/L.

  9. Gylcemia 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 two visits to NCH and sent to the NCH lab for analysis. Adiponectin will be measured in ng/ml.

  10. Gylcemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panal [ Time Frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum) ]
    Blood will be collected during two visits to 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 md/dL and mmol/L.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We are assessing postpartum weight loss, therefore participants must be female to have the ability to give birth
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+ years
  • 30-40 weeks' gestation
  • Diagnosed with GDM in current pregnancy
  • English language ability adequate for participating
  • 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 multiple (i.e. twin, triple, 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), or taking medications affecting body weight
  • Live outside 35 mile radius
  • Woman is an appointed surrogate
  • Infant will be adopted after delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664089


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Sarah Keim
Ohio Department of Health
Ohio State University
American Diabetes Association
Investigators
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Principal Investigator: Sarah Keim, PhD, MA, MS Nationwide Children's Hospital

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Responsible Party: Sarah Keim, Principal Investigator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03664089     History of Changes
Other Study ID Numbers: 18-00178
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications