An interventional study of Ankle weights (2.5 pounds [1.1 kg]/ankle) and Control in Gestational Diabetes, sponsored by Sarah Keim. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Sarah Keim · Not applicable, Interventional, and Prevention
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 75 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Sarah Keim is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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)
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, ankle weights (2.5 pounds \[1.1 kg\]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
Weight loss
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.
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Body Fat %
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.
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
BMI
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.
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Waist-hip Ratio
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.
Time frame: 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)
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.
Time frame: 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
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.
Time frame: 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)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. HbA1c will be analyzed as a percentage.
Time frame: 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
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.
Time frame: 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)
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. hsCRP will be measured in mg/L.
Time frame: 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
Blood will be collected during both visits at NCH and sent to the NCH lab for analysis. Adiponectin will be measured in µg/mL.
Time frame: 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
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.
Time frame: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Sarah Keim