Call-2-Health: Preventing Type II Diabetes (C2H)
2017年10月11日 更新者：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
調査の概要
研究の種類
介入
入学 (実際)
47
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Washington
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Seattle、Washington、アメリカ、98101
- Group Health Research Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～74年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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.
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Program feasibility: Uptake
時間枠：Baseline
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Measured by the number of people who consent to be in the study compared to the number who were eligible
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Baseline
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Program feasibility: Attendance
時間枠：12 weeks
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Measured by the number of participants who return for their 12 week clinic visit
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12 weeks
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Program feasibility: Attendance
時間枠：24 weeks
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Measured by the number of participants who return for their 24 week clinic visit
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24 weeks
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Program feasibility: Attendance
時間枠：52 weeks
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Measured by the number of participants who complete their 52 week assignments (3 day pedometer, self-reported weight, fasting blood draw)
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52 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Fasting glucose
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Waist circumference
時間枠：Baseline, 12 weeks, 24 weeks
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in centimeters
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Baseline, 12 weeks, 24 weeks
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Blood pressure
時間枠：Baseline, 12 weeks, 24 weeks
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Measured using an automated clinical blood pressure monitor (Brand name: Omron, Model number HEM-907XL)
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Baseline, 12 weeks, 24 weeks
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Healthy eating habits
時間枠：Baseline, 12 weeks, 24 weeks
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Assessed using the Food Frequency Questionnaire
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Baseline, 12 weeks, 24 weeks
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Weight loss
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Weight measured in kilograms
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Changes in activity
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured using the Modifiable Activity Questionnaire (MAQ)
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Glycated hemoglobin (A1C)
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Total cholesterol (TC)
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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High density lipoprotein (HDL)
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via a fasting blood draw
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Low density lipoprotein (LDL)
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Measured via fasting blood draw.
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Body Mass Index (BMI)
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Baseline, 12 weeks, 24 weeks, 52 weeks
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Physical activity level
時間枠：Baseline, 12 weeks, 24 weeks, 52 weeks
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Participants wore a blinded pedometer for 3 days
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Baseline, 12 weeks, 24 weeks, 52 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Katherine Newton, PhD、Group Health Research Institute
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年7月1日
一次修了 (実際)
2011年10月1日
研究の完了 (実際)
2012年6月1日
試験登録日
最初に提出
2012年9月11日
QC基準を満たした最初の提出物
2013年4月5日
最初の投稿 (見積もり)
2013年4月10日
学習記録の更新
投稿された最後の更新 (実際)
2017年10月13日
QC基準を満たした最後の更新が送信されました
2017年10月11日
最終確認日
2017年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。