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Improving Weight Management at the VA

1 giugno 2018 aggiornato da: VA Office of Research and Development

Improving Weight Management at VA: Enhancing the MOVE!23 for Primary Care (CDA 10-206)

Compared to the general public, a higher percentage of Veterans are obese or overweight with a weight-related medical condition. The VA currently offers an effective weight management program called MOVE!, but the majority of eligible patients do not attend. Veterans see their primary care providers (PCPs) very frequently, making it an important place to receive information on weight management. However, PCPs often fail to discuss weight management with patients, so interventions are needed to encourage weight management counseling within the team-based care model used in primary care at the VA. Investigators used focus groups, interviews, and other research methods to develop the MOVE! Toward Your Goals (MTG) intervention. This intervention combines online tools, counseling by a health coach, and the team-based care model to deliver weight management information to patients.

Investigators will conduct a randomized controlled trial of 320 Veteran patients and their providers at two VA sites (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) to study the impact of the 12-month MTG intervention when compared to Enhanced Usual Care. Veterans in the MTG intervention arm will take the MTG tool, receive personalized weight management materials, health coach counseling, and go to their scheduled primary care (PC) visit. After the initial visit, MTG-arm Veterans will receive follow up telephone coaching over 12 months. All Veterans will attend follow-up visits at 3, 6 and 12 months to assess body mass index, diet and physical activity, and goal attainment.

The objectives of this study are to: (a) test the impact of the MTG intervention on weight and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting techniques; and (c) determine the impact of the MTG intervention on primary care team obesity-related counseling practices and attitudes.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately counsel patients about their weight due to lack of time and training. Thus, tools and brief interventions are needed to support providers' behavior change counseling. The VA currently offers the MOVE! program to treat overweight and obese patients, but only 9% of eligible patients attend. At the same time, Veterans on average see their PCPs 3.6 times per year, which supports the importance of developing primary care (PC)-based interventions. The United States Preventive Services Task force (USPSTF) recommends the use of the 5As framework (Assess, Advise, Agree, Assist, Arrange [5A]) for counseling patients about weight.

Interactive behavior change technologies utilizing expert system software programs are an innovative way to facilitate 5As counseling to promote behavior change in primary care. These programs perform computerized risk, lifestyle, and theory- based, behavioral assessment to provide computer-generated, tailored advice to patients. They also can provide information to healthcare teams.

Collaborative goal setting can be used to achieve behavior change in this intervention. This construct, a critical component of several behavior change theories and models and corresponding to "agree" in the 5As model, has been widely recommended for health promotion in primary care. Investigators did formative work using key informant interviews with several VA Patient Aligned Care Teams (PACT), MOVE! staff, and focus groups with Veterans demonstrated that goal setting is feasible and acceptable to patients and PACT teamlets, and provided insight on barriers to goal setting, and ways to facilitate goal-setting conversations.

During the development phase of this project, investigators developed a primary care-based intervention called MOVE! Toward Your Goals (MTG) to facilitate weight management within primary care and increase adoption of intensive VA programs such as MOVE!. The MTG intervention uses a new MTG software tool (that the investigators developed) delivered on tablets to facilitate 5As-based weight management counseling with a health coach and healthcare team to promote goal-setting, behavior change, and weight loss in the primary care setting. The Veteran also receives follow up with 12 health coaching calls over 1 year.

Investigators will conduct a large, multicenter (Manhattan and Brooklyn campuses, New York Harbor Healthcare System) randomized controlled trial of 320 subjects, who will be randomized to receive either Enhanced Usual Care or the MTG Intervention.

The objectives of this study are to: (a) test the impact of the MTG intervention on weight and behavior changes; (b) identify predictors of weight loss in Veterans who use goal setting techniques; and (c) determine the impact of the MTG intervention on primary care team obesity-related counseling practices and attitudes.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

45

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
    • New York
      • Brooklyn, New York, Stati Uniti, 11209
        • Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY
      • New York, New York, Stati Uniti, 10010
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

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 18 anni a 69 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Has not participated in MOVE! in the past year
  • Age 18-69 (this age range represents MOVE! eligibility)
  • BMI of 30kg/m2 or a BMI of 25 kg/m2 with obesity-associated condition
  • Under the care of PCP with at least 1 prior visit with the provider in the past 12 months
  • Access to a telephone
  • Able to travel to Brooklyn or Manhattan VA for in-person evaluations at 3, 6, and 12 months

Exclusion Criteria:

  • Non-Veterans
  • A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD-9) codes
  • Diabetes diagnosis via ICD-9 code
  • Primary care provider recommends that the patient should not participate
  • Severe arthritis, valvular disease, cardiac arrhythmia, pregnancy, and/or other conditions (indicated by PCP) limiting moderate PA
  • Self-reported inability to read at a 5th grade level due to literacy level or vision problems

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: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1: Receiving MOVE! Toward Your Goals
Receiving MOVE! Toward Your Goals intervention (MTG tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)
Comportamentale: MOVE! Toward Your Goals
Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members
Altri nomi:
  • MTG arm
Comparatore attivo: Arm 2: Receiving Enhanced Usual Care
Receiving Enhanced Usual Care (standard VA Health Living Messages handouts, potential support of weight management efforts from primary care provider)
Comportamentale: Enhanced Usual Care
Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Altri nomi:
  • EUC arm

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Weight Change (kg)
Lasso di tempo: 3 Months
Weight Change from baseline to 3 months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.
3 Months
Weight Change (kg)
Lasso di tempo: 6 Months
Change in weight from baseline to 6-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.
6 Months
Weight Change (kg)
Lasso di tempo: 12 months
Change in weight from baseline to the 12-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.
12 months
Percent of Patients With Clinically Significant Weight Loss
Lasso di tempo: 3 months
The percentage of patients who achieve 5-10% weight loss at 3- month study visit.
3 months
Percent of Patients With 2.5% Weight Loss at 6 Months.
Lasso di tempo: 6 months
Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.
6 months
Percent of Patients With Clinically Significant Weight Loss
Lasso di tempo: 6 months
The percentage of patients who achieve 5-10% weight loss at 6- month study visit.
6 months
Percent of Patients Who Achieved 2.5% Weight Loss
Lasso di tempo: 12 months
Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.
12 months
Percent of Patients With Clinically Significant Weight Loss
Lasso di tempo: 12 months
The percentage of patients who achieve 5-10% weight loss at 12- month study visit.
12 months

Collaboratori e investigatori

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

Sponsor

VA Office of Research and Development

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)

3 agosto 2015

Completamento primario (Effettivo)

31 maggio 2017

Completamento dello studio (Effettivo)

5 marzo 2018

Date di iscrizione allo studio

Primo inviato

29 settembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

8 dicembre 2015

Primo Inserito (Stima)

10 dicembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 dicembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2018

Ultimo verificato

1 giugno 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CDP 12-252
  • CDA 10-206 (Altro numero di sovvenzione/finanziamento: Veterans Administration)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

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

prodotto fabbricato ed esportato dagli 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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