- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01923350
Avoiding Diabetes After Pregnancy Trial (ADAPT)
Increasing Adoption of Early Intervention to Prevent Diabetes After Gestational Diabetes Mellitus
The Avoiding Diabetes After Pregnancy Trial (ADAPT) study was designed to test the effectiveness of interventions that potentially increase the adoption of Diabetes Prevention Program (DPP) elements by women who had a pregnancy with gestational diabetes mellitus (GDM).
The study was conducted as an integrated trial with two separate arms: one to facilitate weight reduction and the other to increase diabetes testing.
There were two hypotheses:
- Women in the testing intervention will be more likely to have received a diabetes test within the 6 months post-intervention than women in the control group.
- Women in the weight reduction intervention will have lost more weight at the 6-month and 9-month follow-up than women in the control group.
The primary study aim was to determine the efficacy of a system of interactive technology-based supports to prompt women with a history of gestational diabetes to take steps to prevent diabetes. The secondary aims were focused on women's engagement:
- To evaluate the impact of the weight reduction intervention in terms of participant engagement with the interactive technology-based supports.
- To evaluate changes in the women's perception of their personal diabetes risk following after exposure to information about diabetes risk following a pregnancy with GDM.
- To identify the determinants and motivators of and barriers to diabetes testing in the 6- to 12-week postpartum period and thereafter, using the Health Belief model to guide the study.
There was an additional secondary aim involving metformin:
- To evaluate the impact of the diabetes risk reduction intervention in terms of women seeking out their physician's advice on metformin treatment and receiving a metformin prescription, if appropriate.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Silver Spring, Maryland, 미국, 20910
- Social & Scientific Systems Inc.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
General
- History of GDM in the previous 6 months to 4.5 years
- Access to the internet and text messages or phone messages
- Current patient of Harvard Vanguard Medical Associates
- 18 years of age or older
- Able to read in English
Weight Reduction Group
- Overweight or obese
- Capable of performing moderate physical activity
Diabetes Testing Group
- Had not competed a diabetes test (OGTT or fasting blood sugar at 6-12 weeks postpartum or OGTT, fasting blood sugar or hemoglobin A1c after 12 weeks postpartum)
Exclusion Criteria:
General:
- Diabetes diagnosis
- Psychotic disorder diagnosis
- Enrolled in a research study
Weight Reduction Group
- Taking prescription medications for weight loss
- Engaged in a formal weight reduction program
Diabetes Testing Group
- History of postpartum OGTT, fasting plasma glucose or hemoglobin A1c (after 6 weeks postpartum)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Weight Reduction Intervention
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The weight trial intervention components were:
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활성 비교기: Weight Reduction Control Arm
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Participants received an initial brochure about managing diabetes risk, a digital scale to use in entering their weights in online questionnaires, and monthly emailed wellness messages unrelated to diabetes.
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활성 비교기: Tested for diabetes
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Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a sub-sample of those tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
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활성 비교기: Not tested for diabetes
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Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a subsample of those not tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
For participants in weight group, weight reduction from baseline to 6 months
기간: 6 months
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Participants reported their weights online at baseline, 3 months, 6 months, and 9 months, and the difference in weight from baseline to 6 months was the primary measure of the intervention's success.
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6 months
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In testing group, the number of women receiving a diabetes test per ADA Guidelines in the 6-month post-intervention period
기간: 6 months
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The number of women who were tested in the 6 months following the intervention was determined from electronic medical records.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Weight intervention participant engagement with the interactive technology-based supports
기간: 9 months
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Measured by separate scores for taking part in behavioral support (coaching calls) and electronic feedback (women responding on goal performance via daily text messaging (SMS)or weekly IVR, chosen by the participant).
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9 months
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Success of participants in weight intervention arm in achieving behavior change goals.
기간: 9 months
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Information from daily SMS and weekly IVR responses to questions about participants' success in achieving behavior change goals were used to construct achievement scores.
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9 months
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Weight change from baseline to 9 months
기간: 9 months
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Differences were calculated in weights entered on baseline and 9-month surveys for intervention and control arms in the weight group.
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9 months
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Weight change from 6 to 9 months
기간: 3 months
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Difference in weights recorded in 6-month and 9-month questionnaires was calculated for all participants in the weight group.
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Susan J Griffey, DPh, BSN, Social & Scientific Systems Inc.
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
중량 감소에 대한 임상 시험
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AO Clinical Investigation and Publishing Documentation빼는적절한 골유합술로 교정할 수 없는 요골두의 골절 | 외상 후 기형 또는 관절 | 요골두 골절의 실패한 ORIF(Open Reduction Internal Fixation) | 실패한 보수적 요골두 골절 치료
Weight Reduction Intervention에 대한 임상 시험
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University of North Carolina, Chapel HillWeight Watchers International완전한
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Medical University of South CarolinaWeight Watchers International완전한
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The Miriam HospitalUniversity of Tennessee; Weight Watchers International완전한
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VA Office of Research and Development모집하지 않고 적극적으로
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Washington University School of MedicineSt. Jude Children's Research Hospital완전한