Virtual Lifestyle Program Evaluation During Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
21 kwietnia 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Aktywny, nie rekrutujący
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Obserwacyjny
Zapisy (Oczekiwany)
100
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Manitoba
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Winnipeg, Manitoba, Kanada, R2V 3M3
- Chronic Disease Innovation Centre, Seven Oaks Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Participants will be recruited from individuals enrolled in the online program and willing and able to give informed consent for participation in the evaluation
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Impact of COVID-19 survey
Ramy czasowe: 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
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Start of the program - first week of enrollment
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Program adherence
Ramy czasowe: 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.
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16 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)
Ramy czasowe: 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)
Ramy czasowe: 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.
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16 weeks
|
|
Dietary intake
Ramy czasowe: 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
Ramy czasowe: 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.
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16 weeks
|
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Dietary habits
Ramy czasowe: 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.
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16 weeks
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Sleep
Ramy czasowe: 16 weeks
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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.
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16 weeks
|
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Stress
Ramy czasowe: 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.
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16 weeks
|
|
High-density lipoprotein Cholesterol (HDL-C)
Ramy czasowe: 16 weeks
|
HDL-C will be measured at the start and end of program.
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16 weeks
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|
Total cholesterol
Ramy czasowe: 16 weeks
|
Total cholesterol will be measured at the start and end of program.
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16 weeks
|
|
Low-density lipoprotein cholesterol (LDL-C)
Ramy czasowe: 16 weeks
|
LDL-C will be measured at the start and end of program.
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16 weeks
|
|
Triglycerides
Ramy czasowe: 16 weeks
|
Triglycerides will be measured at the start and end of program.
|
16 weeks
|
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Total cholesterol/HDL ratio
Ramy czasowe: 16 weeks
|
Total cholesterol/HDL ratio will be measured at the start and end of program.
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16 weeks
|
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Fasting blood glucose
Ramy czasowe: 16 weeks
|
Fasting blood glucose will be measured at the start and end of program.
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16 weeks
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Insulin
Ramy czasowe: 16 weeks
|
Insulin will be measured at the start and end of program.
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16 weeks
|
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Hemoglobin A1C
Ramy czasowe: 16 weeks
|
Hemoglobin A1C will be measured at the start and end of program.
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16 weeks
|
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Body weight
Ramy czasowe: 16 weeks
|
Body weight will be measured at the start and end of program.
|
16 weeks
|
|
BMI
Ramy czasowe: 16 weeks
|
BMI will be measured at the start and end of program.
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16 weeks
|
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Systolic blood pressure
Ramy czasowe: 16 weeks
|
Systolic blood pressure will be measured in triplicate the start and end of program.
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16 weeks
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Diastolic blood pressure
Ramy czasowe: 16 weeks
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Diastolic blood pressure will be measured in triplicate the start and end of program.
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16 weeks
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Medication intake
Ramy czasowe: 16 weeks
|
Participant's medication intake will be tracked and assessed the start and end of program.
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16 weeks
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Cardiovascular assessment
Ramy czasowe: 16 weeks
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Framingham score will be used to assess participant's 10-year risk of cardiovascular disease the start and end of program.
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16 weeks
|
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Impact of COVID-19-focus groups
Ramy czasowe: First 3 months of program initiation
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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
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First 3 months of program initiation
|
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Program acceptability - exit survey
Ramy czasowe: Program completion at 16 weeks
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A study exit survey will be used to evaluate the program acceptability.
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Program completion at 16 weeks
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Program acceptability - focus groups
Ramy czasowe: Within 3 months of completing the program
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Focus groups will be conducted with a subset of participants after completion of the program to obtain feedback.
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Within 3 months of completing the program
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Evaluate participant's program engagement and learning
Ramy czasowe: At the end of the study
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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.
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At the end of the study
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 marca 2021
Zakończenie podstawowe (Oczekiwany)
31 maja 2022
Ukończenie studiów (Oczekiwany)
31 lipca 2022
Daty rejestracji na studia
Pierwszy przesłany
8 lutego 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
4 marca 2021
Pierwszy wysłany (Rzeczywisty)
5 marca 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
29 kwietnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 kwietnia 2022
Ostatnia weryfikacja
1 kwietnia 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HS24424(H2020:495)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .