- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02343354
The MoMMii Study. Diabetes Prevention Intervention on Families With Past Gestational Diabetes (MoMMii)
The MoMMii Study: Effects of a Multimodal Diabetes Prevention Intervention on Families With a History of Gestational Diabetes
Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes; their children show more insulin resistance and diabetes compared to offspring of mother without diabetes in pregnancy. An increased diabetes risk is also observed among partner of adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The investigators are now enhancing the program to engage directly the partner (MoMMii program).
In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal diabetes prevention program that includes healthy meal preparation training, discussion of eating and physical activity behaviours and developing home environments that facilitate healthy habits, pedometer-based step count monitoring, and participation in family-based activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment, floor resistance exercises). Participants will be encouraged to communicate between sessions with study personnel and with one another to create a between family support network. All mothers and fathers will participate in five sessions over six months. The investigators will examine changes in health-related behaviours, blood pressure, glucose levels, and insulin sensitivity/resistance in both mothers and fathers.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H3A 1A1
- McGill University Health Centre - Royal Victoria Hosptial
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Prior history of gestational diabetes in the mother
- Ability to speak and read English or French
Exclusion Criteria:
- Other forms of diabetes (e.g., type 1 diabetes, type 2 diabetes)
- Current use of antihyperglycemic medication
- Pregnancy or attempting to become pregnant
- Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
- Current smoker
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Nutrition/physical activity intervention
There will be five in-person group sessions (3 to 4 weeks appart) with on-site child care.
Sessions will include preparation of a healthy meal (hands-on) and discussions of mindful eating, balanced meals, portion sizes, and preparing food at home, under a dietitian's supervision.
Sessions will also include a one-hour physical activity information/practice session with a kinesiologist.
Participants will track daily step counts with a pedometer and aim to eventually reach more than 10,000 steps/day.
They will also receive instruction and demonstration from a kinesiologist of some simple resistance exercises they may perform at home.
Between sessions, participants will receive advice and support through a study-specific website, telephone calls and phone applications.
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Please see arm description
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers
기간: 20-24 weeks
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Following an overnight fast and venous blood sampling for fasting glucose, a 75 gram glucose solution will be consumed by the participant and two hours later, venous blood will be sampled for a repeat serum glucose assay.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in fruit and vegetable consumption in mothers and fathers
기간: 20-24 weeks
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Estimates of consumption based on food frequency questionnaire data completed by mothers and fathers.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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Change in physical activity in mothers and fathers
기간: 20-24 weeks
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Daily physical activity assessed by accelerometers and pedometer-based step counts in mothers and fathers.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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Change in insulin resistance measure (HOMA-IR) in mothers and fathers
기간: 20-24 weeks
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Homeostatic Assessment of insulin resistance (HOMA-IR) calculated with fasting glucose and fasting insulin values.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers
기간: 20-24 weeks
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Using the ratio of the serum insulin levels at the 0 minute and 120-minute time points, the insulin sensitivity index (ISI 0, 120), another marker of insulin resistance, will be calculated as proposed in Gutt M, Davis CL, Spitzer SB, Llabre MM, Kumar M, Czarnecki EM et al.
Validation of the insulin sensitivity index (ISI(0,120)): comparison with other measures.
Diabetes Res Clin Pract 2000; 47(3):177-184.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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Change in fasting glucose in mothers and fathers
기간: 20-24 weeks
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Following an overnight fast, venous blood will be sampled for assessment of fasting glucose.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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Change in fasting insulin in mothers and fathers
기간: 20-24 weeks
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Following an overnight fast, venous blood will be sampled for assessment of fasting insulin.
The pre-intervention value will be subtracted from the post-intervention value to compute the change during the intervention.
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20-24 weeks
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Change in systolic blood pressure in mothers and fathers
기간: 20-24 weeks
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Systolic blood pressure will assessed with the participant seated in a quiet room with the arm supported.
Measurements will be taken with an automated device at 1-minute intervals for 6 sequential measurements.
The latter 5 measurements will be averaged.
The pre-intervention (average) systolic blood pressure will be subtracted from the post-intervention (average) systolic blood pressure for computation of the change in systolic blood pressure.
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20-24 weeks
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Change in diastolic blood pressure in mothers and fathers
기간: 20-24 weeks
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Diastolic blood pressure will assessed with the participant seated in a quiet room with the arm supported.
Measurements will be taken with an automated device at 1-minute intervals for 6 sequential measurements.
The latter 5 measurements will be averaged.
The pre-intervention (average) diastolic blood pressure will be subtracted from the post-intervention (average) diastolic blood pressure for computation of the change in systolic blood pressure.
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20-24 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kaberi Dasgupta, MD, MSc, McGill University and McGill University Health Centre
간행물 및 유용한 링크
일반 간행물
- Brazeau AS, Leong A, Meltzer SJ, Cruz R, DaCosta D, Hendrickson-Nelson M, Joseph L, Dasgupta K; MoMM study group. Group-based activities with on-site childcare and online support improve glucose tolerance in women within 5 years of gestational diabetes pregnancy. Cardiovasc Diabetol. 2014 Jun 30;13:104. doi: 10.1186/1475-2840-13-104.
- Leong A, Rahme E, Dasgupta K. Spousal diabetes as a diabetes risk factor: a systematic review and meta-analysis. BMC Med. 2014 Jan 24;12:12. doi: 10.1186/1741-7015-12-12.
- Dasgupta K, Da Costa D, Pillay S, De Civita M, Gougeon R, Leong A, Bacon S, Stotland S, Chetty VT, Garfield N, Majdan A, Meltzer S. Strategies to optimize participation in diabetes prevention programs following gestational diabetes: a focus group study. PLoS One. 2013 Jul 4;8(7):e67878. doi: 10.1371/journal.pone.0067878. Print 2013.
- Brazeau AS, Meltzer SJ, Pace R, Garfield N, Godbout A, Meissner L, Rahme E, Da Costa D, Dasgupta K. Health behaviour changes in partners of women with recent gestational diabetes: a phase IIa trial. BMC Public Health. 2018 May 2;18(1):575. doi: 10.1186/s12889-018-5490-x.
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 (실제)
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. .
Nutrition/physical activity intervention에 대한 임상 시험
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Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한