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The MoMMii Study. Diabetes Prevention Intervention on Families With Past Gestational Diabetes (MoMMii)

2018년 3월 20일 업데이트: Kaberi Dasgupta, MD, MSc, FRCP (C), McGill University Health Centre/Research Institute of the McGill University Health Centre

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

The primary goal of the project is to determine if, among families with a history of gestational diabetes mellitus (GDM) in the mother in the prior five years, a family-based multimodal health behaviour intervention (group cooking and eating/physical activity counselling, telephone-based app and text support, building of peer and within-family social support for health behaviour change) will lead to reductions in post 75g glucose load serum glucose values in mothers and fathers. The previous MoMM pilot study demonstrated an 8% reduction in mothers, similar in magnitude to that observed in a large diabetes prevention trial conducted among adults with impaired glucose tolerance (Tuomieltho et al, N Engl J Med 2001). MoMMii will ascertain if expansion to a family-based approach amplifies effects in mothers and demonstrates impact in fathers and children. Thus, MoMMii will shift the focus from the mother to the family. A systematic review and meta-analysis showed diabetes risk to be shared between spouses (Leong et al, BMC Medicine, 2014). GDM also confers higher risk for insulin resistance and overweight in offspring. Thus, this project plans to create a collaborative home environment that facilitates choices consistent with diabetes prevention for all family members. Sixty-six families will be recruited through GDM clinics at McGill University Health Centre and other centres. Five in-person sessions (meal preparation training, eating and physical activity counselling) will take place once a month at the PERFORM Centre, Concordia University. Each session will involve discussion of strategies to achieve healthy eating, hands-on meal preparation, and group-based physical activity. Sessions will engage couples as well as mothers and fathers separately. 'Healthy living' concepts will be integrated into the on-site childcare structure (meal preparation, games, videos). The intervention team will include a dietitian and kinesiologist. A health coach will facilitate networking among participating families and development of lay group leaders to sustain health behaviour changes between sessions and post program. Outcomes will be evaluated in mothers, fathers (e.g., fasting and post load glucose and insulin resistance measures, fruit/vegetable intake, step counts, eating behaviours, blood pressure) and offspring (dietary/physical activity habits).

연구 유형

중재적

등록 (실제)

118

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Quebec
      • Montreal, Quebec, 캐나다, H3A 1A1
        • McGill University Health Centre - Royal Victoria Hosptial

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

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Prior history of gestational diabetes in the mother
  2. Ability to speak and read English or French

Exclusion Criteria:

  1. Other forms of diabetes (e.g., type 1 diabetes, type 2 diabetes)
  2. Current use of antihyperglycemic medication
  3. Pregnancy or attempting to become pregnant
  4. Chronic condition/ medications that could impact weight (e.g. malignancy, weight loss medications, anti-depressants)
  5. Current smoker

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
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.
Please see arm description
다른 이름들:
  • 라이프스타일 개입
  • Diabetes prevention intervention

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in post 75 gram glucose load 2-hour glucose value in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Change in fruit and vegetable consumption in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in physical activity in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in insulin resistance measure (HOMA-IR) in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in insulin sensitivity measure (ISI 0,120) in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in fasting glucose in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in fasting insulin in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in systolic blood pressure in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks
Change in diastolic blood pressure in mothers and fathers
기간: 20-24 weeks
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.
20-24 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Kaberi Dasgupta, MD, MSc, McGill University and McGill University Health Centre

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

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

2014년 11월 1일

기본 완료 (실제)

2017년 6월 1일

연구 완료 (실제)

2017년 6월 1일

연구 등록 날짜

최초 제출

2015년 1월 15일

QC 기준을 충족하는 최초 제출

2015년 1월 21일

처음 게시됨 (추정)

2015년 1월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 20일

마지막으로 확인됨

2018년 3월 1일

추가 정보

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아니요

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Nutrition/physical activity intervention에 대한 임상 시험

3
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