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

21. april 2022 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Impact of COVID-19 survey
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical activity level - International Physical Activity Questionnaire-Long (IPAQ-L)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 16 weeks
HDL-C will be measured at the start and end of program.
16 weeks
Total cholesterol
Tidsramme: 16 weeks
Total cholesterol will be measured at the start and end of program.
16 weeks
Low-density lipoprotein cholesterol (LDL-C)
Tidsramme: 16 weeks
LDL-C will be measured at the start and end of program.
16 weeks
Triglycerides
Tidsramme: 16 weeks
Triglycerides will be measured at the start and end of program.
16 weeks
Total cholesterol/HDL ratio
Tidsramme: 16 weeks
Total cholesterol/HDL ratio will be measured at the start and end of program.
16 weeks
Fasting blood glucose
Tidsramme: 16 weeks
Fasting blood glucose will be measured at the start and end of program.
16 weeks
Insulin
Tidsramme: 16 weeks
Insulin will be measured at the start and end of program.
16 weeks
Hemoglobin A1C
Tidsramme: 16 weeks
Hemoglobin A1C will be measured at the start and end of program.
16 weeks
Body weight
Tidsramme: 16 weeks
Body weight will be measured at the start and end of program.
16 weeks
BMI
Tidsramme: 16 weeks
BMI will be measured at the start and end of program.
16 weeks
Systolic blood pressure
Tidsramme: 16 weeks
Systolic blood pressure will be measured in triplicate the start and end of program.
16 weeks
Diastolic blood pressure
Tidsramme: 16 weeks
Diastolic blood pressure will be measured in triplicate the start and end of program.
16 weeks
Medication intake
Tidsramme: 16 weeks
Participant's medication intake will be tracked and assessed the start and end of program.
16 weeks
Cardiovascular assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Manitoba

Samarbejdspartnere

Chronic Disease Innovation Centre, Seven Oaks Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2021

Primær færdiggørelse (Forventet)

31. maj 2022

Studieafslutning (Forventet)

31. juli 2022

Datoer for studieregistrering

Først indsendt

8. februar 2021

Først indsendt, der opfyldte QC-kriterier

4. marts 2021

Først opslået (Faktiske)

5. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HS24424(H2020:495)

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