Physical Activity Intervention for Gestational Diabetes (GDM)
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ohio
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Columbus, Ohio, Stati Uniti, 43205
- Nationwide Children's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Weight loss
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Body Fat %
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Sarah Keim, PhD, MA, MS, Nationwide Children's Hospital
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 18-00178
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