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Completed

NCT Number: NCT03664089

Physical Activity Intervention for Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle weights (2.5 pounds [1.1 kg]/ankle)

Behavioral

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.

Control

Behavioral

Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Sarah Keim

Other

Collaborators

  • American Diabetes Association
  • Ohio Department of Health
  • Ohio State University

Registry information

Acronym: GDM

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2018
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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