Teaching Appropriate Gestational Weight Gain (TAGG)
13 augusti 2019 uppdaterad av: Geisinger Clinic
The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.
Studieöversikt
Detaljerad beskrivning
The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.
The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.
Studietyp
Interventionell
Inskrivning (Faktisk)
218
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Health System
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
- Less than 16 weeks gestation
- Gestational weight gain (GWG) less than < 11 pounds from their pre-pregnancy weight to time of potential study enrollment
- Singleton gestation
- Access to a phone
Exclusion Criteria:
- BMI less than 30 kg/m2
- Gestational age greater than or equal to 16 weeks
- Active diagnosis of cancer on their electronic health record problem list
- Acquired immunodeficiency syndrome (AIDS)
- Palliative medicine patients
- Multiple gestations
- GWG in excess of 11 pounds prior to study enrollment
- Patients with Non-Geisinger prenatal care providers
- Vegan diet
- Malabsorptive conditions
- Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
- Non-English Speaking
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Standard of Care (SOC)
Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.
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Experimentell: Enhanced Care (EC)
In addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. |
In addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Gestational weight gain, adjusting for time in the study
Tidsram: at delivery
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at delivery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Patient knowledge and expectations factors
Tidsram: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Attitude on pregnancy weight gain
Tidsram: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Self-efficacy of healthy eating
Tidsram: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Eating, sleeping and physical activity behavior
Tidsram: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Patient-experience and involvement in care
Tidsram: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs.
This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care.
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Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Delivery of large for gestational age infants
Tidsram: At Delivery
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This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data.
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At Delivery
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Diagnosis of gestational diabetes mellitus
Tidsram: Baseline through 4-12 Weeks Postpartum
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This measure will be obtained using EHR data and analyzed utilizing clinic data points.
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Baseline through 4-12 Weeks Postpartum
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Neonatal intensive care unit (NICU) admissions
Tidsram: At Delivery
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At Delivery
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Cost of Treatment
Tidsram: Baseline through 4-12 Weeks Postpartum
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Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost.
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Baseline through 4-12 Weeks Postpartum
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Mode of delivery
Tidsram: At Delivery
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Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest.
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At Delivery
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Rate of gestational weight gain
Tidsram: Baseline through 4-12 weeks postpartum
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Baseline through 4-12 weeks postpartum
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Perceived stress measured via Perceived Stress Scale
Tidsram: Baseline through 4-12 weeks postpartum
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Perceived Stress will be measured using the Perceived Stress Scale by Cohen et.
al.
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Baseline through 4-12 weeks postpartum
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Psychological factors measured via Pregnancy Weight Gain Attitude Scale
Tidsram: Baseline through 4-12 Weeks postpartum
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Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et.
al.
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Baseline through 4-12 Weeks postpartum
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Awathif D Mackeen, MD, MPH, Geisinger Clinic
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2016
Primärt slutförande (Faktisk)
1 juli 2018
Avslutad studie (Faktisk)
1 juli 2019
Studieregistreringsdatum
Först inskickad
12 oktober 2016
Först inskickad som uppfyllde QC-kriterierna
10 november 2016
Första postat (Uppskatta)
15 november 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 augusti 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 augusti 2019
Senast verifierad
1 augusti 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2016-0205
Plan för individuella deltagardata (IPD)
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OBESLUTSAM
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