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Weight Loss Intervention for Individuals With Lower Extremity Amputation (MOVE-LEAP)

2 maggio 2018 aggiornato da: VA Office of Research and Development

Home-based Weight Loss Intervention for Individuals With Lower Extremity Amputation

The purpose of this study is to pilot test a program to help overweight and obese individuals with a lower extremity amputation (LEA) lose weight and become more physically active. The investigators will randomize approximately 30 individuals to either a self-directed weight loss program (n=15) or a coached weight loss program (n=15). The primary purpose of this pilot study is to determine if a home-based weight loss/physical activity (PA) intervention is feasible in individuals with a LEA. MOVE-LEAP is a 20-week program that involves 11 phone calls from a health coach and a single home visit by a physical therapist.

This pilot study aims to:

  1. test the feasibility of recruiting overweight/obese individuals with LEA into a randomized trial;
  2. assess whether the intervention can be delivered with high fidelity, and
  3. evaluate whether the intervention is acceptable to and safe as determined by participant feedback, participation and retention for outcome measures.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Participants randomized to the intervention arm will receive (1) a home visit by an exercise specialist and (2) a 20-week telephone-delivered weight loss program, modeled on the VA's Telephone Lifestyle Coaching Program (MOVE!TLC). All participants (both the coached arm and self-directed arm) will be mailed a MOVE-LEAP packet [containing eating and physical activity logs, information on how to set weight loss goals, suggestions for physical activity/exercise, dietary guides, etc.), a MOVE-LEAP handout booklet, calories counting book, a pedometer, exercise digital versatile disc (DVD), and a flip-booklet with exercises ("Exercise Guide for Persons with Limb Loss"). A bathroom scale will be provided for participants who do not already own one.

Participants in the coached arm will receive a home visit by an exercise specialist. This visit will occur 1-3 weeks after randomization. The exercise specialist will assess the participant's capabilities and interest regarding physical activity as well as his/her home environment for physical activity. Since each participant may have different physical capabilities and limitations, the type and intensity of physical activity will be tailored to each participant's preferences and their home and neighborhood/community environment and resources. If the participant is interested in performing physical activity outside their home, study staff will provide them with information about community resources for physical activities.

Participants in the coached arm will receive 11 calls by a study health coach. During the phone calls (weekly initially and then every other week), the health coach will review progress and help the participant to set "SMART" goals (Specific, Measurable, Attainable, Relevant and Time-limited) and will use motivational interviewing techniques to help the participant achieve those goals. Motivational interviewing is a style of counseling meant to increase participant engagement through strategic use of open-ended questions, reflective listening and positive affirmations. The study staff will review the participant's progress on his or her goals and help him or her problem solve to resolve challenges and modify goals as needed. During each session, the coach will discuss an educational topic relating to weight loss. Written materials on each topic are included the booklet.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

15

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
    • Washington
      • Seattle, Washington, Stati Uniti, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

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:

  • Lower extremity amputation (including toes) for at least 1 year
  • overweight or obese
  • <60 minutes drive-time to VA Puget Sound Health Care System - Seattle campus, willing to be randomized
  • provides written, informed consent
  • able to perform some form of aerobic exercise (e.g., walking, bicycling, swimming)
  • has telephone
  • able to complete study assessments

Exclusion Criteria:

  • Co-morbidities which may be contraindicated or indicate no potential benefit from weight loss or increasing physical activity
  • unlikely to be able to adhere to study protocol and complete questionnaires and measurements reliably
  • recent or current (last 6 months) participation in a weight loss program, including taking weight loss medications
  • only uses motorized (non-manual) wheelchair

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Coached
Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.
Comportamentale: Coached group
Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur
Comparatore attivo: Self-directed
Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Comportamentale: Self-directed control group
Participants randomized to the self-directed control arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
Altro: Screened
Individuals who were contacted to inform them about the study or who contacted study personnel to express an interest in participating. This group is presented in order to present statistics on feasibility regarding recruitment
Altro: Screened only
Screened only - No intervention -- individuals who are contacted and/or screened for eligibility

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Individuals That Were Randomized of Those Contacted (Feasibility)
Lasso di tempo: During recruitment (expected duration of 12-15 months)
Specific components include yield by method, recruitment rate, refusal rates and reasons
During recruitment (expected duration of 12-15 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility - Retention
Lasso di tempo: Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)
Number of randomized individuals who complete baseline and study exit visit
Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)
Acceptability
Lasso di tempo: At follow-up assessment (20-weeks follow-up)
Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend
At follow-up assessment (20-weeks follow-up)
Change in Weight
Lasso di tempo: Baseline and follow-up assessment (20-weeks after randomization)
Changes between baseline and 20-weeks later (end of intervention)
Baseline and follow-up assessment (20-weeks after randomization)
Change in 6-minute Walk Distance
Lasso di tempo: Baseline and at follow-up assessment (20-weeks after randomization)
Change in 6-minute walk distance (ft) from baseline to follow-up
Baseline and at follow-up assessment (20-weeks after randomization)

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)

20 febbraio 2014

Completamento primario (Effettivo)

16 novembre 2015

Completamento dello studio (Effettivo)

1 maggio 2018

Date di iscrizione allo studio

Primo inviato

17 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

10 marzo 2014

Primo Inserito (Stima)

13 marzo 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • F6982-Wa

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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