Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

2 maj 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

15

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 69 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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
Aktiv komparator: 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.
Beteende: 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.
Övrig: 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
Övrig: Screened only
Screened only - No intervention -- individuals who are contacted and/or screened for eligibility

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Individuals That Were Randomized of Those Contacted (Feasibility)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Feasibility - Retention
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

VA Office of Research and Development

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

20 februari 2014

Primärt slutförande (Faktisk)

16 november 2015

Avslutad studie (Faktisk)

1 maj 2018

Studieregistreringsdatum

Först inskickad

17 januari 2014

Först inskickad som uppfyllde QC-kriterierna

10 mars 2014

Första postat (Uppskatta)

13 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 juni 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 maj 2018

Senast verifierad

1 maj 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • F6982-Wa

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Amputation av nedre extremiteter

Kliniska prövningar på Coached group

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Chile

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera