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Integrating Online Weight Management With Primary Care Support (PROPS)

9 ottobre 2020 aggiornato da: Heather J. Baer, Brigham and Women's Hospital

Integrating Online Weight Management With Primary Care Support: Patient-Centered Strategies for Addressing Overweight and Obesity in Primary Care

The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are:

  1. a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention.

    b. To compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online program and with usual care.

    Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months compared with the stand-alone online program and with usual care.

  2. To identify mediators of the combined intervention and the stand-alone online program.

    Hypothesis 2: The effects of the combined intervention and the stand-alone online program on weight loss will be mediated by patients' level of engagement, changes in self-efficacy, and changes in diet and physical activity.

  3. To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics.

Hypothesis 3: The interventions will be more effective among patients who are younger, white, and higher socioeconomic status, although the population management strategy may help to reduce these differences.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Focus Groups and Key Informant Interviews:

Focus groups will be conducted with 5 to 7 patients at the beginning of the study to obtain their feedback about an online program and the population health management support strategy. To be eligible for the focus groups, patients must have a Brigham and Women's Hospital (BWH) primary care clinician, be between ages 20-70 years old, and have a recent BMI (in the past year) between approximately 27 and 40 kg/m2. They should also be interested in weight management and/or motivated to lose weight.

Phone interviews will be conducted at the end of the study to solicit feedback on the BMIQ program and the population health management intervention. Patients in the PROPS Study who are assigned to the online program or combined intervention arm, reach the 18-month timepoint, and complete the final study survey are eligible and will be invited to participate.

Key Informant Interviews will be conducted at the beginning and the end of the study. To be eligible, the key informants must be clinicians or other staff who provide services to patients at one of the participating BWH primary care practices. There are a total of 165 clinicians in these practices, including staff physicians, residents or fellows, and nurse practitioners or physician assistants. Approximately 7 clinicians at each timepoint will be recruited as key informants and will also be asked to complete electronic surveys during the trial.

After adapting the online weight management program and integrating it with the population management support strategy based on our focus groups and key informant interviews, investigators will conduct a three-arm cluster-randomized trial to compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online weight management program and with usual care. This will be a pragmatic clinical trial conducted in approximately 14 BWH primary care practices. To be eligible for the trial, patients must have an upcoming scheduled visit at a BWH primary care practice, BMI between 27 and 39.9 kg/m2 at enrollment, and a diagnosis of type 2 diabetes or hypertension. They also must be between ages 20 and 70 (inclusive) at enrollment, speak English or Spanish, and have access the Internet using a computer, tablet, or smart phone. Finally, patients must be motivated to lose weight. Investigators plan to recruit a total of 840 patients for the study (280 per arm). Patients who enroll in the trial will attend regular primary care visits at their practices and also will complete surveys by e-mail, regular mail, or phone.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

840

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

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Women's Hospital

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

Da 20 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. upcoming or recent visit at primary care practice affiliated with Brigham and Women's Hospital
  2. age 20-70
  3. diagnosis of type 2 diabetes and/or hypertension
  4. BMI >= 27 and < 40 kg/m2
  5. motivated to lose weight
  6. valid email address and access the Internet using a computer, tablet, or smartphone
  7. English or Spanish-speaking

Exclusion Criteria:

1. on insulin for treatment of their diabetes 2. MI, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in last 6 months 3. Unstable angina 4. Currently pregnant or planning to become pregnant during the study period 5. Currently lactating 5. Has had bariatric surgery or planning to have bariatric surgery 6. >5% weight loss in the last 6 months 7. Severe psychiatric illness or impaired mental status 8. Active or diagnosed history of and/or self-reported history of eating disorders 9. Self-reported average consumption of > 14 alcoholic drinks/week 10. Any serious medical condition that would affect weight loss or for which weight loss is contraindicated, including active cancer (excluding non-melanoma skin cancer) or currently being treated for cancer, end stage renal disease (ESRD) on dialysis, etc.

11. On comfort care measures, hospice, or in nursing home 12. Participating in a contra-indicative research study 13. Use of prescription or over-the-counter weight loss medications or an all-liquid diet program in the last 6 months or currently 14. Any other medical contraindication for weight loss or physical activity, or any other reason that the PCP or their delegate (e.g., LPN or RN) did not deem the patient appropriate for the study

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: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Online Program Only
Patients will use an online weight management program called BMIQ, with minimal additional support.
Comportamentale: Online weight management program
Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.
Sperimentale: Combined Intervention
Patients will use an online weight management program called BMIQ, but will also receive additional monitoring and support from a population health manager who works with their primary care practices.
Comportamentale: Online weight management program
Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.
Comportamentale: Population health management support
Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
Nessun intervento: Usual Care
Patients will continue receiving usual care but will also be mailed some general written information about weight management (very minimal intervention.)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Weight at 12 Months
Lasso di tempo: 12 months after the initial primary care visit
change in body weight from enrollment to 12 months
12 months after the initial primary care visit

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Weight at 6 Months
Lasso di tempo: 6 months after the initial primary care visit
change in body weight from enrollment to 6 months
6 months after the initial primary care visit
Change in Body Weight at 18 Months
Lasso di tempo: 18 months after the initial primary care visit
change in body weight from enrollment to 18 months
18 months after the initial primary care visit
Percent Weight Change at 6 Months
Lasso di tempo: 6 months after the initial primary care visit
Percent weight change from enrollment to 6 months
6 months after the initial primary care visit
Percent Weight Change at 12-Months
Lasso di tempo: 12 months after the initial primary care visit
Percent weight change from enrollment to 12 months
12 months after the initial primary care visit
Percent Weight Change at 18-Months
Lasso di tempo: 18 months after the initial primary care visit
Percent weight change from enrollment to 18 months
18 months after the initial primary care visit
Percent of Patients With at Least 5% Weight Loss at 6 Months
Lasso di tempo: 6-months after the initial primary care visit
Percent of Patients With at Least 5% Weight Loss from enrollment to 6 months
6-months after the initial primary care visit
Percent of Patients With at Least 5% Weight Loss at 12-months
Lasso di tempo: 12 months after the initial primary care visit
Percent of Patients with at least 5% weight loss from enrollment to 12 months
12 months after the initial primary care visit
Percent of Patients With at Least 5% Weight Loss at 18 Months
Lasso di tempo: 18-months after the initial primary care visit
Percent of Patients With at least 5% weight loss from enrollment to 18 months
18-months after the initial primary care visit
Changes in Self-efficacy Around Weight Loss at 12 Months
Lasso di tempo: 12 months after initial primary care visit
Changes in self-efficacy around weight loss at 12 months Self-efficacy will be assessed by asking patients to rate their confidence in their ability to lose weight on a scale from 1 ("not at all confident") to 10 ("very confident"). A rank of 1-7 reflects low self-efficacy, while 8-10 reflects high self-efficacy based on Bandura's theory of self-efficacy.
12 months after initial primary care visit
Changes in Systolic Blood Pressure
Lasso di tempo: 12 months after the initial primary care visit
changes in systolic blood pressure (BP) from enrollment to 12 months
12 months after the initial primary care visit
Changes in Diastolic Blood Pressure
Lasso di tempo: 12 months after the initial primary care visit
changes in diastolic blood pressure (BP) from enrollment to 12 months
12 months after the initial primary care visit
Changes in Total Cholesterol
Lasso di tempo: 12 months after the initial primary care visit
changes in total cholesterol from Enrollment to 12 Months
12 months after the initial primary care visit
Changes in HDL Cholesterol
Lasso di tempo: 12 months after the initial primary care visit
changes in HDL cholesterol from Enrollment to 12 Months
12 months after the initial primary care visit
Changes in LDL Cholesterol
Lasso di tempo: 12 months after the initial primary care visit
changes in LDL cholesterol from Enrollment to 12 Months
12 months after the initial primary care visit
Changes in Triglycerides
Lasso di tempo: 12 months after the initial primary care visit
changes in triglycerides from enrollment to 12 months
12 months after the initial primary care visit
Changes in HbA1c Levels
Lasso di tempo: 12 months after the initial primary care visit
changes in Hemoglobin (HbA1c) levels from enrollment to 12 months
12 months after the initial primary care visit
Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
Weight-related quality of life will be assessed using the Impact of Weight of Quality of Life (IWQOL)-Lite questionnare. The IWQOL-Lite is a brief, 31-item self-report measure that consists of scores on five scales (physical function, self-esteem, sexual life, public distress, and work) and a total score (sum of scale scores). Participants are asked to rate items with respect to the past week, with responses from "never true" to "always true". Total scores range from 0 (worst possible quality of life) to 100 (best possible quality of life).
12 months after the initial primary care visit
Changes in Percentage of Patients Reporting Excellent/Very Good Health Status Assessed by Using a 5-point Scale Questionnaire From the 36-Item Short Form Health Survey(SF-36)
Lasso di tempo: 12 months after the initial primary care visit
Health status will be assessed using 5-point scale response to a single question from the SF-36, "In general, would you say that your health is...(1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor"). A higher score indicates a worse outcome (5= poor health status).
12 months after the initial primary care visit
Changes in Self-reported Physical Activity
Lasso di tempo: 12 months after the initial primary care visit
changes in self-reported physical activity minutes per week
12 months after the initial primary care visit
Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
changes in diet, specifically fruits/vegetables as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
12 months after the initial primary care visit
Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
changes in diet, specifically whole grains as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
12 months after the initial primary care visit
Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
changes in diet, specifically sugar-sweetened beverages as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
12 months after the initial primary care visit
Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
changes in diet, specifically baked products as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
12 months after the initial primary care visit
Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
changes in diet, specifically processed meats as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
12 months after the initial primary care visit
Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire
Lasso di tempo: 12 months after the initial primary care visit
changes in diet, specifically fried foods as measured by the PrimeScreen questionnaire, a brief dietary screening tool.
12 months after the initial primary care visit

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Brigham and Women's Hospital

Collaboratori

Patient-Centered Outcomes Research Institute

Investigatori

  • Investigatore principale: Heather Baer, ScD, Brigham and Women's Hospital

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

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 (Effettivo)

19 luglio 2016

Completamento primario (Effettivo)

8 novembre 2018

Completamento dello studio (Effettivo)

8 maggio 2019

Date di iscrizione allo studio

Primo inviato

4 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

13 gennaio 2016

Primo Inserito (Stima)

15 gennaio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2020

Ultimo verificato

1 ottobre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2015P002372

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 .

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