Physical Activity Intervention for Gestational Diabetes (GDM)
19 juli 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
75
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Columbus, Ohio, Verenigde Staten, 43205
- Nationwide Children's Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
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Placebo-vergelijker: Control
All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Weight loss
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Body Fat %
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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BMI
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Waist-hip Ratio
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Hemoglobin A1c (HbA1c)
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
HbA1c will be analyzed as a percentage.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Leptin
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: High sensitivity c-reactive protein (hs-CRP)
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
hsCRP will be measured in mg/L.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Adiponectin
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Blood will be collected during both visits at NCH and sent to the NCH lab for analysis.
Adiponectin will be measured in µg/mL.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Lipid Panel
Tijdsspanne: NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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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.
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NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sarah Keim, PhD, MA, MS, Nationwide Children's Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 september 2018
Primaire voltooiing (Werkelijk)
22 februari 2022
Studie voltooiing (Werkelijk)
1 juli 2022
Studieregistratiedata
Eerst ingediend
5 september 2018
Eerst ingediend dat voldeed aan de QC-criteria
7 september 2018
Eerst geplaatst (Werkelijk)
10 september 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 juli 2022
Laatste update ingediend die voldeed aan QC-criteria
19 juli 2022
Laatst geverifieerd
1 juli 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 18-00178
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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