- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04420936
Ricerca pragmatica nelle strutture sanitarie per migliorare la prevenzione e la cura del diabete e dell'obesità per il nostro programma (MAINTAIN PRIME)
Ricerca pragmatica nelle strutture sanitarie per migliorare la prevenzione e la cura del diabete e dell'obesità per il nostro programma MAINTAIN PRIME (Promozione dell'implementazione reale (mondiale) attraverso i team di assistenza).
Many people struggle not only to lose weight through changes in diet and physical activity, but also to maintain weight loss once they have achieved it. In a previous study, our team designed and deployed a weight maintenance intervention that was delivered through the patient portal of an electronic health record (EHR) and found that patients who tracked their weight, diet, and physical activity and also received coaching had better success with maintaining recent intentional weight loss than patients who tracked but did not receive coaching. The investigators propose to repeat the intervention in a new health care system and train routine health care staff (e.g., medical assistants and nurses) to be coaches, a more sustainable model that will allow ongoing intervention delivery after the proposed study ends.
This is a pragmatic randomized clinical Trial with percent weight change at 24 months as the primary outcome. This will be a 2-arm randomized trial that compares the MAINTAIN PRIME lifestyle coaching intervention to a control tracking intervention.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Obesity is a major health problem in the United States and associated with increased risk of diabetes. While many behavioral interventions have led to successful short-term weight loss, very few programs focus on weight loss maintenance after intentional loss, and fewer still are applicable to routine health care settings. There is a great need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing health care teams. The investigators have developed and tested an innovative weight loss maintenance intervention - Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) - delivered through the electronic health record (EHR) to help patients maintain recent intentional weight loss and successful lifestyle strategies.
The investigators have conducted and published a randomized clinical trial of MAINTAIN-pc at the University of Pittsburgh and found that participants who received EHR tracking tools and personalized coaching had significantly lower weight regain at 24 months (primary outcome) than participants who received EHR tracking tools alone. MAINTAIN-pc leveraged commonly available health information technology (HIT) tools to track participant progress and support patients and their providers in ongoing efforts to maintain weight loss. The investigators used an EHR platform (Epic) employed by many health care systems nationwide and integrated many parts of the MAINTAIN-pc protocol (e.g., patient identification, provider updates) with routine clinic workflow.
Despite the success of MAINTAIN-pc, two key questions about the practicality and sustainability of this intervention remain unanswered: (i) whether the HIT could be adapted at other sites and (ii) whether coaching could be delivered leveraging existing staff resources rather than interventionists supported by a research grant. The investigators propose a pragmatic clinical trial to test the implementation and impact of the MAINTAIN-pc protocol in routine health care settings: MAINTAIN PRIME (Promoting Real (World) IMplEmentation). MAINTAIN PRIME will be conducted in 14 primary care practices affiliated with the University of Utah and will capitalize on further advances in HIT (e.g., dashboards to track patient populations) and team-based care models to deliver the intervention with minimal support from research staff. The investigators will measure costs to inform future sustainability, and study workflow and individual, clinical, and organizational attributes to determine facilitators and barriers to successful implementation. With assistance from an External Advisory Board, the investigators will assemble an Implementation Toolkit of HIT and clinical resources to aid further dissemination.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah Health Sciences Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adults aged 18-75
- BMI of ≥ 25 prior to this intended weight loss
- Have experienced and maintained an intentional weight loss of at least 5% of body weight in the past 24 months
- Plan to maintain a University of Utah Health relationship in one of the participating primary care practices
- Have or be willing to get an account with the Epic MyHealth patient portal embedded in the electronic health record (EHR)
Exclusion Criteria:
- Medical conditions that might cause unintended weight loss such as cancer or thyroid disease
- Provider's assessment that patient is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- Edematous state that interferes with bodyweight assessment (e.g., severe congestive heart failure, end-stage renal disease, or ascites)
- Bariatric surgery in the last 2 years, or planned during the next 3 years
- Current or planned pregnancy in the next 3 years
- Currently breastfeeding
- Perceived lack of basic computer or Internet skills.
- Unable to attend the orientation/baseline visit or comply with the protocol procedures
- Any other underlying reason or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the participant at undue risk.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Allenamento sullo stile di vita
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Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback. |
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Comparatore attivo: Controlla il tracciamento
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Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Body Weight at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
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Baseline and 24 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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BMI at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
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Baseline and 24 months
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Physical Activity as Measured in Daily Steps at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
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Baseline and 24 months
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Daily Minutes of Physical Activity at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
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Baseline and 24 months
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Dietary Habits as Measured by Mediterranean Diet Scale Score at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
|
A Mediterranean diet scale total score is a metric used to measure how closely a person's eating habits adhere with traditional, health-promoting Mediterranean diets. This 14 point scale, scored from 0-13 with higher scores indicating greater adherence. |
Baseline and 24 months
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Pain Intensity
Lasso di tempo: Baseline and 24 months
|
Pain intensity as measured from a single Patient-Reported Outcomes Measurement Information System (PROMIS) question asking participants to rate their average pain over the past 7 days on a numeric rating scale from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity, reported as mean (SD) at baseline and 24 months. |
Baseline and 24 months
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Quality of Function as Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire Scores at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
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The PROMIS Physical Function (PF) scale evaluates a patient's ability to perform daily activities. It is graded on a standardized T-score metric ranging from 20 to 80, where 50 represents the average U.S. general population and every 10 points represent one standard deviation. Higher scores consistently indicate better physical function. |
Baseline and 24 months
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Systolic Blood Pressure at Baseline and 24 Months
Lasso di tempo: Baseline and 24 months
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Baseline and 24 months
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema endocrino
- Malattie metaboliche
- Peso corporeo
- Cambiamenti di peso corporeo
- Disturbi del metabolismo del glucosio
- Condizioni patologiche, segni e sintomi
- Comportamento
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Comportamento, animale
- Perdita di peso
- Diabete mellito
- Comportamento alimentare
Altri numeri di identificazione dello studio
- IRB_00132802
- 1R18DK123372-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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