Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

21. April 2022 aktualisiert von: Claudio Rigatto, University of Manitoba

Virtual Lifestyle Programming to Limit Collateral Health Damage From COVID 19 Pandemic: an Evaluation

This is a pilot study evaluating an online cardiometabolic and weight loss program which is offered by The Wellness Institute. The program is 16 weeks and is developed by a multidisciplinary team and delivered by a degreed health professional (health coach) to assist participants in achieving their personal wellness goals. This study will also investigate the impact of Coronavirus Disease (COVID-19) on participants lifestyles and access to lifestyle programs and supports.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The Wellness Institute is offering a new cardiometabolic and weight loss program. It is a digital behavior change program designed to help clients achieve healthy weight reduction, thereby improving cardiometabolic risk. The target population is overweight or obese individuals at risk for or living with health conditions such as pre-diabetes, diabetes, hypertension and high cholesterol. The purpose of this study is to evaluate the program following a mixed methods quasi-experimental approach using focus groups, questionnaires, and data collected over the 16 week duration of the program. Participants will be asked to fill in a set of questionnaires to measure physical activity, diet, sleep and stress at the start and end of the program. Other outcomes include changes in body weight, body mass index (BMI), blood pressure, clinical chemistry, and medication intake over the 16 week program. At the end of the program, adherence will be measured though attendance and platform usage and acceptability will be measured by an exit questionnaire and virtual focus groups. This study will investigate the impact of COVID-19 on participants lifestyles and access to lifestyle programs and support. The impact of COVID-19 will be assessed through a Covid-19 questionnaire and virtual focus groups.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Manitoba
      • Winnipeg, Manitoba, Kanada, R2V 3M3
        • Chronic Disease Innovation Centre, Seven Oaks Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Participants will be recruited from individuals enrolled in the online program and willing and able to give informed consent for participation in the evaluation

Beschreibung

Program inclusion criteria:

• Male or female, aged 18 years or above, have one or more of the following conditions: pre-diabetes, diabetes, high blood pressure, high triglycerides, low HDL, abdominal obesity, and BMI >25 kg/m2.

Program exclusion criteria:

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the program.
  • Recent heart attack, stroke, heart surgery, and congestive heart failure.
  • Participants who have unmanaged diabetes, chest pain or difficulty breathing.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Impact of COVID-19 survey
Zeitfenster: Start of the program - first week of enrollment
A COVID-19 wellbeing survey will be used to understand the impact of COVID-19 pandemic on lifestyle behaviours and programs and services have changed in response to COVID-19
Start of the program - first week of enrollment
Program adherence
Zeitfenster: 16 weeks
Participants will be qualified as adhering to the program if they attend a minimum of 3 out of 4 health coaching sessions and have at least 1 activity during weeks 12-18.
16 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)
Zeitfenster: 16 weeks
International Physical Activity Questionnaire-Long (IPAQ-L) will be used to evaluate participant's physical activity level for the last 7 days at the start and end of program. It comprises a set of 4 questionnaires and 5 activity domains asked independently. This questionnaire assesses the types of intensity of physical activity and the amount of sitting time that people do as part of their daily lives. These are used to estimate total physical activity in MET-min/week and time spent sitting.
16 weeks
Physical activity level - International Physical Activity Questionnaire-Short (IPAQ-S)
Zeitfenster: 16 weeks
International Physical Activity Questionnaire-Short (IPAQ-S) will be used to evaluate participant's physical activity level for the last 7 days at the start and end of program. It comprises a set of 4 questionnaires and 4 generic items. This questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. These are used to estimate total physical activity in MET-min/week and time spent sitting.
16 weeks
Dietary intake
Zeitfenster: 16 weeks
Automated Self-Administered Recall System (ASA24) 3-day food recall will be used as tool to recall 3 days of dietary intake at the start and end of program.
16 weeks
Dietary behavior
Zeitfenster: 16 weeks
Three factor questionnaire will evaluate changes in participant's dietary habits at the start and end of program. It measures 3 dimensions of human eating behavior: cognitive restraint of eating, disinhibition and hunger.
16 weeks
Dietary habits
Zeitfenster: 16 weeks
Mindful eating questionnaire will evaluate changes in participant's dietary behaviors at the start and end of program. It evaluates emotional and behavioral eating habits in designated populations. A higher score may indicate better outcome in long term body weight maintenance.
16 weeks
Sleep
Zeitfenster: 16 weeks
Pittsburgh sleep quality index (PSQI) questionnaire will be used to evaluate changes in sleep at the start and end of program. The PSQI is used to measure the quality and patterns of sleep in adults. It includes seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. A score of 5 or less is indicated as good sleep quality where a score of 6 or more is indicated as poor sleep quality.
16 weeks
Stress
Zeitfenster: 16 weeks
Perceived stress questionnaire (PSQ) will be used to evaluate changes in stress at the start and end of program. The PSQ is developed as an instrument for assessing the stressful life events and circumstances that tend to trigger or exacerbate disease symptoms.
16 weeks
High-density lipoprotein Cholesterol (HDL-C)
Zeitfenster: 16 weeks
HDL-C will be measured at the start and end of program.
16 weeks
Total cholesterol
Zeitfenster: 16 weeks
Total cholesterol will be measured at the start and end of program.
16 weeks
Low-density lipoprotein cholesterol (LDL-C)
Zeitfenster: 16 weeks
LDL-C will be measured at the start and end of program.
16 weeks
Triglycerides
Zeitfenster: 16 weeks
Triglycerides will be measured at the start and end of program.
16 weeks
Total cholesterol/HDL ratio
Zeitfenster: 16 weeks
Total cholesterol/HDL ratio will be measured at the start and end of program.
16 weeks
Fasting blood glucose
Zeitfenster: 16 weeks
Fasting blood glucose will be measured at the start and end of program.
16 weeks
Insulin
Zeitfenster: 16 weeks
Insulin will be measured at the start and end of program.
16 weeks
Hemoglobin A1C
Zeitfenster: 16 weeks
Hemoglobin A1C will be measured at the start and end of program.
16 weeks
Body weight
Zeitfenster: 16 weeks
Body weight will be measured at the start and end of program.
16 weeks
BMI
Zeitfenster: 16 weeks
BMI will be measured at the start and end of program.
16 weeks
Systolic blood pressure
Zeitfenster: 16 weeks
Systolic blood pressure will be measured in triplicate the start and end of program.
16 weeks
Diastolic blood pressure
Zeitfenster: 16 weeks
Diastolic blood pressure will be measured in triplicate the start and end of program.
16 weeks
Medication intake
Zeitfenster: 16 weeks
Participant's medication intake will be tracked and assessed the start and end of program.
16 weeks
Cardiovascular assessment
Zeitfenster: 16 weeks
Framingham score will be used to assess participant's 10-year risk of cardiovascular disease the start and end of program.
16 weeks
Impact of COVID-19-focus groups
Zeitfenster: First 3 months of program initiation
Focus groups will be conducted with a subset of participants to understand the impact of the COVID-19 pandemic on lifestyle behaviors and on how individuals' needs and perspectives on lifestyle programs and services have changed in response to COVID-19
First 3 months of program initiation
Program acceptability - exit survey
Zeitfenster: Program completion at 16 weeks
A study exit survey will be used to evaluate the program acceptability.
Program completion at 16 weeks
Program acceptability - focus groups
Zeitfenster: Within 3 months of completing the program
Focus groups will be conducted with a subset of participants after completion of the program to obtain feedback.
Within 3 months of completing the program
Evaluate participant's program engagement and learning
Zeitfenster: At the end of the study
Participant's involvement will be assessed by measuring participant learning and engagement. Participant learning will be measured by the proportion of the workbook steps completed and review of health library educational materials. Engagement in the program will be estimated by the average activity participants engaged in per week.
At the end of the study

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Manitoba

Mitarbeiter

Chronic Disease Innovation Centre, Seven Oaks Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2021

Primärer Abschluss (Voraussichtlich)

31. Mai 2022

Studienabschluss (Voraussichtlich)

31. Juli 2022

Studienanmeldedaten

Zuerst eingereicht

8. Februar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2021

Zuerst gepostet (Tatsächlich)

5. März 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HS24424(H2020:495)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Gewichtsverlust

Klinische Studien zur Lifestyle program

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Philippines

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren