Teaching Appropriate Gestational Weight Gain (TAGG)
2019년 8월 13일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
218
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Pennsylvania
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Danville, Pennsylvania, 미국, 17822
- Geisinger Health System
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Gestational weight gain, adjusting for time in the study
기간: at delivery
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at delivery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient knowledge and expectations factors
기간: 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
기간: 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
기간: 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
기간: 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 eating, sleeping and physical activity behaviors.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
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Patient-experience and involvement in care
기간: 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
기간: 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
기간: 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
기간: At Delivery
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At Delivery
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Cost of Treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Awathif D Mackeen, MD, MPH, Geisinger Clinic
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 11월 1일
기본 완료 (실제)
2018년 7월 1일
연구 완료 (실제)
2019년 7월 1일
연구 등록 날짜
최초 제출
2016년 10월 12일
QC 기준을 충족하는 최초 제출
2016년 11월 10일
처음 게시됨 (추정)
2016년 11월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 8월 13일
마지막으로 확인됨
2019년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2016-0205
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Enhanced Care에 대한 임상 시험
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Boston아직 모집하지 않음자살 생각 | 자살 시도 | 자살
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Massachusetts General HospitalVanderbilt University Medical Center; University of Kentucky; University of Texas at Austin완전한
-
University of Massachusetts, WorcesterCenters for Disease Control and Prevention완전한
-
Massachusetts General HospitalNational Institutes of Health (NIH); Samaritans of Boston아직 모집하지 않음자살 생각 | 자살 시도 | 자살