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The Peer Assisted Lifestyle Intervention (PAL)

9 februari 2022 bijgewerkt door: VA Office of Research and Development

Testing the Efficacy of a Technology-assisted Intervention to Improve Weight Management of Obese Patients Within Patient Aligned Care Teams at the VA

The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a health coach and the VA PACT healthcare team to promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. The PAL intervention also includes 10-12 health-coaching calls to the patient over 12 months.

As part of a cluster-randomized controlled study, the investigators will randomize 17 PACT teams at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care control. The primary aim of the study is to explore differences in feasibility, acceptability, and intermediate, behavioral, and weight loss outcomes at 6 and 12 months of 520 patients recruited from the randomized PACTs.

Objective:

1) Explore the feasibility and impact of this intervention on intermediate, behavioral, and weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual care.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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) 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. The MOVE!11 software is an expert system program for VA patients referred to MOVE!, but is not currently used in primary care by Patient-Aligned Care Teams (PACT).

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. The investigators' formative work (MIRB #01333) using key informant interviews with PACT teamlets and 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, the 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 PAL intervention uses the 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 10-12 health coaching calls over 1 year.

As part of a clustered randomized control trial, the investigators will randomize 17 PACT teams to either Enhanced Usual Care or the PAL Intervention, recruiting 520 subjects.

STUDY OBJECTIVES

  • Test the impact of the PAL intervention on weight change and behavioral/clinical outcomes
  • Identify predictors of weight loss in Veterans participating in the intervention group related to goal setting processes and intervention components
  • Determine the impact of the PAL intervention on PACT obesity-related counseling practices and attitudes

Studietype

Ingrijpend

Inschrijving (Werkelijk)

281

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10010
        • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 69 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age 18-69 (this age range represents MOVE! eligibility)
  • BMI of 30kg/m2 or a BMI of 25kg/m2 with obesity-associated condition
  • Under the care of PCP with at least 1 prior visit with the provider in the past 24 months
  • Access to a telephone
  • Able to travel to Brooklyn VA for in-person evaluations at baseline, 6, and 12 months

Exclusion Criteria:

  • Non-Veterans
  • A documented current history of active psychosis, active bipolar disorder, or other cognitive issues via ICD-10 codes
  • Undergoing insulin-therapy for diabetes
  • Self-reported inability to read at a 5th grade level due to literacy level or vision problems
  • Has attended more than 4 MOVE! sessions in the past year
  • Pregnancy
  • PCP stating that Veteran should not participate

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PAL Intervention

Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity

Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider)
Gedragsmatig: Peer Assisted Lifestyle
Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.
Andere namen:
  • PAL arm
Actieve vergelijker: Enhanced Usual Care (EUC)
Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity
Gedragsmatig: 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.
Andere namen:
  • EUC arm

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Weight Loss
Tijdsspanne: 6 and 12 months
Mann-Whitney tests for continuous outcomes (e.g., weight loss)
6 and 12 months
Difference in achievement of 5% weight loss
Tijdsspanne: 12 months
Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in HB A1C
Tijdsspanne: 6 and 12 month
Fasting blood tests will be used to determine if patients experience changes in HB A1C level.
6 and 12 month
Changes in waist circumference
Tijdsspanne: 6 and 12 months
Will be used to determine whether patients had changes in waist circumference.
6 and 12 months
Changes in Physical Activity
Tijdsspanne: 6 and 12 months
Measure duration and intensity using the Paffenbarger questionnaire items and accelerometers. The ActiGraph Link (GT9X) accelerometer, worn on the wrist, will be used to objectively measure PA for 7 days at Baseline, and at 6 and 12 months.
6 and 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

VA Office of Research and Development

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

8 januari 2018

Primaire voltooiing (Werkelijk)

31 december 2021

Studie voltooiing (Werkelijk)

31 december 2021

Studieregistratiedata

Eerst ingediend

19 mei 2017

Eerst ingediend dat voldeed aan de QC-criteria

19 mei 2017

Eerst geplaatst (Werkelijk)

23 mei 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 februari 2022

Laatste update ingediend die voldeed aan QC-criteria

9 februari 2022

Laatst geverifieerd

1 februari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IIR 15-378
  • 01607 (Ander subsidie-/financieringsnummer: Veterans Administration)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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