Call-2-Health: Preventing Type II Diabetes (C2H)
2017년 10월 11일 업데이트: Kaiser Permanente
Translating the Diabetes Prevention Project (DPP) in a Health Maintenance Organization (HMO) Setting
It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translate the findings of the Diabetes Prevention Program into practice. The telephonic intervention will be compared to usual care (30 participants in each group). The investigators will deliver the intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24 weeks.
For this planning grant the investigators do not have an overall hypothesis. The investigators' goal is to develop and test whether it is possible to do exercise and weight loss
연구 개요
연구 유형
중재적
등록 (실제)
47
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Washington
-
Seattle, Washington, 미국, 98101
- Group Health Research Institute
-
-
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
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or female
- Age 40-74
- Receives primary care at Group Health Central, Rainier, or Poulsbo clinics in the greater Seattle area
- Can walk for more than 10 minutes
- Fasting plasma glucose (FPG) 105-125 mg/dl or glycolated hemoglobin (HbA1C) 5.7-6.4
- Body Mass Index (BMI) 25 kg/m2 or greater
Exclusion Criteria:
- Type 1 or 2 diabetes
- FPG > 125 mg/dl or < 105mg/dl at screening blood draw
- HbA1C > 6.4 or < 5.7 at screening blood draw
- Systolic blood pressure > 210 mmHg at the baseline clinic visit
- Exercise ≥ 30 minutes/day, at least five days a week
- Current participation in another structured weight loss treatment program or another intervention study
- Severe concurrent disease
- Unavailable for the 24-week study period
- Unable to read or speak English
- Pregnant or planning to become pregnant.
- Mentally or legally incapacitated such that informed consent cannot be obtained.
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 |
|---|---|
|
활성 비교기: Intervention
Participants assigned to the intervention group worked with the study interventionist over the phone to reduce their risk for developing Diabetes Mellitus, Type 2. The intervention lasted for 24 weeks, with weekly phone calls for the first 12 weeks and 4 maintenance calls over the second 12 weeks.
Study measurements were taken at baseline, 12 weeks, 24 weeks, and 52 weeks.
After 24 weeks, the investigators randomly divided the intervention group in half.
The first group did not receive any more phone calls from the interventionist.
The second group continued to receive monthly 20-minute phone calls from the interventionist.
At 52 weeks post-baseline participants from both groups had their labs drawn, wore a pedometer for 3 days, and called in with a self-reported weight.
|
Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks.
The first 12 weeks was the intervention phase and calls were made weekly.
The second 12 weeks was the maintenance phase and calls were made every 3 weeks.
After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls.
The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
|
|
간섭 없음: Control
Participants randomized into this group did not receive any intervention, although they were encouraged to follow-up with their doctor and follow through with usual clinical care.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Program feasibility: Uptake
기간: Baseline
|
Measured by the number of people who consent to be in the study compared to the number who were eligible
|
Baseline
|
|
Program feasibility: Attendance
기간: 12 weeks
|
Measured by the number of participants who return for their 12 week clinic visit
|
12 weeks
|
|
Program feasibility: Attendance
기간: 24 weeks
|
Measured by the number of participants who return for their 24 week clinic visit
|
24 weeks
|
|
Program feasibility: Attendance
기간: 52 weeks
|
Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
|
52 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fasting glucose
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Measured via a fasting blood draw
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
Waist circumference
기간: Baseline, 12 weeks, 24 weeks
|
in centimeters
|
Baseline, 12 weeks, 24 weeks
|
|
Blood pressure
기간: Baseline, 12 weeks, 24 weeks
|
Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
|
Baseline, 12 weeks, 24 weeks
|
|
Healthy eating habits
기간: Baseline, 12 weeks, 24 weeks
|
Assessed using the Food Frequency Questionnaire
|
Baseline, 12 weeks, 24 weeks
|
|
Weight loss
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Weight measured in kilograms
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
Changes in activity
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Measured using the Modifiable Activity Questionnaire (MAQ)
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
Glycated hemoglobin (A1C)
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Measured via a fasting blood draw
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
Total cholesterol (TC)
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Measured via a fasting blood draw
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
High density lipoprotein (HDL)
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Measured via a fasting blood draw
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
Low density lipoprotein (LDL)
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Measured via fasting blood draw.
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
Body Mass Index (BMI)
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
|
|
Physical activity level
기간: Baseline, 12 weeks, 24 weeks, 52 weeks
|
Participants wore a blinded pedometer for 3 days
|
Baseline, 12 weeks, 24 weeks, 52 weeks
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Katherine Newton, PhD, Group Health Research Institute
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
2010년 7월 1일
기본 완료 (실제)
2011년 10월 1일
연구 완료 (실제)
2012년 6월 1일
연구 등록 날짜
최초 제출
2012년 9월 11일
QC 기준을 충족하는 최초 제출
2013년 4월 5일
처음 게시됨 (추정)
2013년 4월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 10월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 10월 11일
마지막으로 확인됨
2017년 10월 1일
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. .