Healthy Living Partnership to Prevent Diabetes (HELP PD)
30 gennaio 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
301
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
North Carolina
-
Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University School of Medicine
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
21 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
Altri nomi:
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.
Altri nomi:
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.
Altri nomi:
|
|
Altro: 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.
|
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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fasting Glucose
Lasso di tempo: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
|
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.
|
Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Weight Loss
Lasso di tempo: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
|
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.
|
Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
|
|
Waist Circumference
Lasso di tempo: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
|
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.
|
Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
|
|
Dietary Intake
Lasso di tempo: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
|
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.
|
Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
|
|
Physical Activity
Lasso di tempo: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
|
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.
|
Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2007
Completamento primario (Effettivo)
1 maggio 2015
Completamento dello studio (Effettivo)
1 maggio 2015
Date di iscrizione allo studio
Primo inviato
5 marzo 2008
Primo inviato che soddisfa i criteri di controllo qualità
5 marzo 2008
Primo Inserito (Stima)
7 marzo 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 febbraio 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 gennaio 2020
Ultimo verificato
1 gennaio 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00000613
- R18DK069901 (Sovvenzione/contratto NIH degli Stati Uniti)
- 1R18DK069901-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .