Healthy Living Partnership to Prevent Diabetes (HELP PD)
2020年1月30日 更新者：Wake Forest University Health Sciences
Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)
The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.
調査の概要
状態
完了
詳細な説明
Social forces have promoted adverse behavioral patterns with respect to physical activity and nutrition resulting in the current epidemics of obesity, the metabolic syndrome and type 2 diabetes mellitus (DM).
Results from clinical trials such as the Diabetes Prevention Program (DPP) have demonstrated a significant potential for prevention of type 2 DM through lifestyle interventions to promote physical activity, a healthy eating pattern and weight loss.
Yet these approaches are not being applied in practice.
In fact, whether these approaches can be successfully implemented in the community is an unanswered question.
The Healthy Living Partnership to Prevent Diabetes (HELP PD) was designed to address this knowledge gap in a community setting.
It incorporates key translations of prior research to enhance logistical and fiscal feasibility and long term dissemination, including the use of a group-based, rather than an individual-based, intensive lifestyle behavioral intervention employing professionals and community health workers (CHWs), and delivery of the intervention in the community setting via expansion of an existing Diabetes Education Program (DEP).
The trial has been continued for an additional 5 years, and the primary goal of the continuation is to test the long-term glucose lowering effects of the HELP PD intervention by randomizing the lifestyle group to continued group maintenance or a self-directed maintenance condition and to follow the UC group for additional comparison purposes.
Demonstrating the longer term effectiveness of HELP PD will represent a key step in establishing the value of this approach to translation of DM prevention into the community.
This crucial evidence will be used to support reimbursement policy for DM prevention, dissemination of the HELP PD CHW approach and generalization to other behaviorally influenced chronic diseases.
研究の種類
介入
入学 (実際)
301
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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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University School of Medicine
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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
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials
- BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2
- Fasting blood glucose 95-125 mg/dl (inclusive)
- Willingness to Accept Randomization
Exclusion Criteria:
- Currently involved in a supervised program for weight loss
- Clinical history of DM, or newly diagnosed DM at screening
- Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure
- Uncontrolled high blood pressure: BP > 160/100
- Pregnancy, breast feeding, or planning pregnancy within 2 years
- Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
- Chronic use of medicine known to significantly affect glucose metabolism, e.g., corticosteroids
- Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP PD, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), and participation in another research study that would interfere with HELP PD
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Lifestyle
This Group-Based Lifestyle Intervention (Phases 1 and 2) will be led by lay health counselors (LHCs).
The 6-month Phase 1 includes weekly meetings on nutrition and physical activity, psychosocial factors related to health behaviors, and question and answer periods.
The 18-month Phase 2 will consist of monthly group meetings and individual telephone contacts.
Intervention participants who choose to participate in the study continuation (Phase 3) will be further randomized to receive either extended group or self-directed maintenance.
Those who are randomized to receive Extended Group Maintenance (Phase 3) will continue attending monthly meetings; those who receive Self-Directed Maintenance (Phase 3) will no longer attend groups.
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This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity.
The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for the first 6-months of treatment (Phase 1) for a total weight loss of 5-7%.
During Phase 2 (months 7-24) participants will be encouraged to continue weight loss as long as their BMI does not fall below 20 kg/m2, but the primary focus will be on weight maintenance.
The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
他の名前：
Individuals from the lifestyle intervention group in the original HELP PD project who are randomized to self-directed maintenance will receive biannual nutrition counseling from the study RDs.
In these sessions, the RD will cover basic aspects of transition from the group maintenance to individual maintenance, answer questions about healthy eating and activity to support weight loss, and discuss existing community resources that may fit the participants' needs as they attempt to maintain their weight loss, physical activity and dietary goals.
他の名前：
The extended group maintenance condition will consist of monthly CHW-led group meetings, monthly individual telephone contacts with the CHW, biannual RD contacts, and other contacts as needed.
During Phase 3, the objectives for Phase 2 of the initial program will be continued.
That is, participants who were successful at weight loss (≥ 7% of initial body weight) are encouraged to either maintain their weight loss or to advance towards their own personal goals.
Participants who were not successful are encouraged to problem solve the reasons for lack of success.
The groups will focus on maintaining the healthy behaviors that produced weight loss and/or problem solving to overcome barriers to weight loss.
他の名前：
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他の：Comparison
The comparison condition exceeds the usual care provided to similar community members and is an individual education program that builds on an increased awareness of existing community resources.
In the initial trial, these subjects will receive two individual sessions with the RD and a monthly newsletter.
In the study continuation, comparison participants will receive biannual nutrition counseling and a monthly newsletter.
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Comparison participants will receive two individual sessions with a nutritionist during the first 3 months.
In these sessions, the RD will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss.
These participants will also receive a monthly newsletter on topics related to healthy lifestyle and will receive the lifestyle intervention manual and video series at the conclusion of their participation.
These participants will be approached about the continuation at 24 months.
If they agree to participate, these participants will continue to receive a monthly newsletter and will also receive biannual RD contacts.
他の名前：
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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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Fasting Glucose
時間枠：Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
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Change in fasting glucose will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year.
The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period.
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Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
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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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Weight Loss
時間枠：Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
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Weight loss will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year.
The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period.
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Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
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Waist Circumference
時間枠：Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
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Waist circumference will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year.
The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period.
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Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
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Dietary Intake
時間枠：Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
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Usual dietary intake will be assessed using a food frequency questionnaire (FFQ) in web-format.
This software will be administered during assessments at the GCRC by trained dieticians on the GCRC staff.
In addition, diet will be monitored daily by intervention participants through completion of their diet and physical activity logs.
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Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
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Physical Activity
時間枠：Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
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We will use the International Physical Activity Questionnaire to evaluate between group differences in physical activity, an internationally reliable and valid instrument for assessing physical activity.
The IPAQ short form is a 7-item index that asks respondents the number of days per week and the amount of time per day spent in vigorous- and moderate-intensity activities and walking, during the seven days prior to the interview.
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Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Katula JA, Vitolins MZ, Rosenberger EL, Blackwell C, Espeland MA, Lawlor MS, Rejeski WJ, Goff DC. Healthy Living Partnerships to Prevent Diabetes (HELP PD): design and methods. Contemp Clin Trials. 2010 Jan;31(1):71-81. doi: 10.1016/j.cct.2009.09.002. Epub 2009 Sep 13.
- Blackwell CS, Foster KA, Isom S, Katula JA, Vitolins MZ, Rosenberger EL, Goff DC Jr. Healthy Living Partnerships to Prevent Diabetes: recruitment and baseline characteristics. Contemp Clin Trials. 2011 Jan;32(1):40-9. doi: 10.1016/j.cct.2010.10.006. Epub 2010 Oct 23.
- Katula JA, Blackwell CS, Rosenberger EL, Goff DC Jr; Healthy Living Partnerships to Prevent Diabetes Research Team. Translating diabetes prevention programs: implications for dissemination and policy. N C Med J. 2011 Sep-Oct;72(5):405-8.
- Rosenberger Hale E, Goff DC, Isom S, Blackwell C, Whitt-Glover MC, Katula JA. Relationship of weekly activity minutes to metabolic syndrome in prediabetes: the healthy living partnerships to prevent diabetes. J Phys Act Health. 2013 Jul;10(5):690-8. doi: 10.1123/jpah.10.5.690. Epub 2012 Oct 4.
- Katula JA, Vitolins MZ, Rosenberger EL, Blackwell CS, Morgan TM, Lawlor MS, Goff DC Jr. One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. Diabetes Care. 2011 Jul;34(7):1451-7. doi: 10.2337/dc10-2115. Epub 2011 May 18. Erratum In: Diabetes Care. 2012 Feb;35(2):455.
- Katula JA, Vitolins MZ, Morgan TM, Lawlor MS, Blackwell CS, Isom SP, Pedley CF, Goff DC Jr. The Healthy Living Partnerships to Prevent Diabetes study: 2-year outcomes of a randomized controlled trial. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S324-32. doi: 10.1016/j.amepre.2012.12.015.
- Lawlor MS, Blackwell CS, Isom SP, Katula JA, Vitolins MZ, Morgan TM, Goff DC Jr. Cost of a group translation of the Diabetes Prevention Program: Healthy Living Partnerships to Prevent Diabetes. Am J Prev Med. 2013 Apr;44(4 Suppl 4):S381-9. doi: 10.1016/j.amepre.2012.12.016.
- Bishop J, Irby MB, Isom S, Blackwell CS, Vitolins MZ, Skelton JA. Diabetes prevention, weight loss, and social support: program participants' perceived influence on the health behaviors of their social support system. Fam Community Health. 2013 Apr-Jun;36(2):158-71. doi: 10.1097/FCH.0b013e318282b2d3.
- Beavers KM, Case LD, Blackwell CS, Katula JA, Goff DC Jr, Vitolins MZ. Effects of weight regain following intentional weight loss on glucoregulatory function in overweight and obese adults with pre-diabetes. Obes Res Clin Pract. 2015 May-Jun;9(3):266-73. doi: 10.1016/j.orcp.2014.09.003. Epub 2014 Oct 5.
- Miller GD, Isom S, Morgan TM, Vitolins MZ, Blackwell C, Brosnihan KB, Diz DI, Katula J, Goff D. Effects of a community-based weight loss intervention on adipose tissue circulating factors. Diabetes Metab Syndr. 2014 Oct-Dec;8(4):205-11. doi: 10.1016/j.dsx.2014.09.003. Epub 2014 Oct 5.
- Pedley CF, Case LD, Blackwell CS, Katula JA, Vitolins MZ. The 24-month metabolic benefits of the healthy living partnerships to prevent diabetes: A community-based translational study. Diabetes Metab Syndr. 2018 May;12(3):215-220. doi: 10.1016/j.dsx.2017.09.011. Epub 2017 Sep 23.
- Vitolins MZ, Isom SP, Blackwell CS, Kernodle D, Sydell JM, Pedley CF, Katula JA, Case LD, Goff DC Jr. The healthy living partnerships to prevent diabetes and the diabetes prevention program: a comparison of year 1 and 2 intervention results. Transl Behav Med. 2017 Jun;7(2):371-378. doi: 10.1007/s13142-016-0447-z.
- Vitolins MZ, Blackwell CS, Katula JA, Isom SP, Case LD. Long-term Weight Loss Maintenance in the Continuation of a Randomized Diabetes Prevention Translational Study: The Healthy Living Partnerships to Prevent Diabetes (HELP PD) Continuation Trial. Diabetes Care. 2019 Sep;42(9):1653-1660. doi: 10.2337/dc19-0295. Epub 2019 Jul 11.
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
2007年8月1日
一次修了 (実際)
2015年5月1日
研究の完了 (実際)
2015年5月1日
試験登録日
最初に提出
2008年3月5日
QC基準を満たした最初の提出物
2008年3月5日
最初の投稿 (見積もり)
2008年3月7日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月5日
QC基準を満たした最後の更新が送信されました
2020年1月30日
最終確認日
2020年1月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- IRB00000613
- R18DK069901 (米国 NIH グラント/契約)
- 1R18DK069901-01A2 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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