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Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

18 juli 2022 bijgewerkt door: David M. Williams, Brown University

Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight [25 < BMI < 30]) or obese (30 < BMI <40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Verwacht)

240

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02912
        • Werving
        • Brown University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 64 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion criteria:

  • ages 50-64
  • BMI 25-40
  • Sedentary or low-active, defined as participating in < 60 min/week of structured exercise
  • Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app

Exclusion criteria:

  • Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):

    • Past 3-month overnight hospitalization
    • Past 3-month treatment for heart disease, including bypass or valve surgery, interventional procedure(s) such as angioplasty (stent), or a pacemaker or other implanted device to control your heart rate or rhythm
    • Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury
    • Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity
    • Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly
    • Past 6-month seizure
    • Past 6-month overnight hospitalization due to respiratory disease
    • Past 6-month lightheadedness, vertigo, dizziness, or fainting
    • Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months
    • Takes insulin and/or medication that affects the secretion of insulin
    • Exercise-induced asthma that prevents brisk walking
    • Takes anticonvulsant medication or medication to treat/control seizures
    • Diagnosed with cystic fibrosis
    • Bone or joint problems that make you unable to walk for at least 30 minutes
    • Physician has said not to exercise because of bone or joint problems
    • Physician has said a hip or knee replacement will be needed in the next 12 months
    • Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes
  • Currently taking or planning on taking medications that affect HR, such as beta or calcium channel blockers or digoxin, as HR will be used to determine the moderate intensity range for participants assigned to that condition
  • Past 12-month overnight psychiatric hospitalization
  • Currently pregnant or planning to become pregnant in the next year
  • Currently participating in any exercise or weight-loss research studies
  • Household member is participating in this study
  • Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
  • Unable to receive materials in the mail at residential mailing address
  • Does not plan to live in Rhode Island for the next 12 months
  • Unable to speak, read, and/or write fluently in English
  • Smokers will be eligible, but smoking status will be included as a covariate in analyses

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Self-Paced Intensity Physical Activity
Gedragsmatig: Self-Paced Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in self-selected intensity PA.
Actieve vergelijker: Prescribed Moderate Intensity Physical Activity
Gedragsmatig: Prescribed Moderate Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in moderate intensity PA consistent with national guidelines.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in total volume of structured PA
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph [model wGT3x-BT]) worn during one-week periods.
Measured at baseline, and months 3, 6, 9, and 12.
Minutes per week of PA
Tijdsspanne: Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
Measured daily from date of randomization for 52 weeks based on participant initiation of exercise

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in Body Weight
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Assessment of self-reported body weight by study-provided scales
Measured at baseline, and months 3, 6, 9, and 12.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Opportunity Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's opportunity to do regular aerobic physical activity
Measured at baseline, and months 3, 6, 9, and 12.
Capability Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's physical and psychological capability to do regular aerobic physical activity
Measured at baseline, and months 3, 6, 9, and 12.
Exercise Motivation Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's motivation on the days they have made a plan to exercise
Measured at baseline, and months 3, 6, 9, and 12.
Habit of Physical Activity Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's habits regarding exercise
Measured at baseline, and months 3, 6, 9, and 12.
Physical Activity Identity Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's personal beliefs regarding exercise
Measured at baseline, and months 3, 6, 9, and 12.
Outcome Expectations for Physical Activity Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about the consequences of exercise
Measured at baseline, and months 3, 6, 9, and 12.
Attitude towards Physical Activity - Affective Attitude Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about exercise
Measured at baseline, and months 3, 6, 9, and 12.
Attitude towards Physical Activity - Instrumental Attitude Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about exercise
Measured at baseline, and months 3, 6, 9, and 12.
Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment)
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures how much a person enjoys exercise; scores range from 18-26 and higher scores mean more physical activity enjoyment
Measured at baseline, and months 3, 6, 9, and 12.
Intention Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's intention to exercise
Measured at baseline, and months 3, 6, 9, and 12.
Chronic Pain Screening Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures how much chronic pain a person had in the past 6 months
Measured at baseline, and months 3, 6, 9, and 12.
Pain Medication Use Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures the medications a person is taking for chronic pain
Measured at baseline, and months 3, 6, 9, and 12.
12 Item Short Form (SF-12) Health Survey
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's views about their health
Measured at baseline, and months 3, 6, 9, and 12.
Quality of Life Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's views about their quality of life and health
Measured at baseline, and months 3, 6, 9, and 12.
Activity Tracker Use Questionnaire
Tijdsspanne: Measured at baseline, and months 3, 6, 9, and 12.
Measures of use of physical activity devices, memberships, and equipment
Measured at baseline, and months 3, 6, 9, and 12.
EMA: Affective response to PA
Tijdsspanne: Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.
Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
EMA: Perceived autonomy
Tijdsspanne: Measured weekly from date of randomization until the end of the study at week 52
Assesses participant's perceived autonomy over exercise behavior.
Measured weekly from date of randomization until the end of the study at week 52
EMA: Perceived exertion
Tijdsspanne: Measured daily from date of randomization until the end of the study at week 52
Assesses participant's perceived exertion during PA.
Measured daily from date of randomization until the end of the study at week 52
EMA: Behavioral intention
Tijdsspanne: Measured daily from date of randomization until the end of the study at week 52
Assesses degree to which participant intends to engage in PA.
Measured daily from date of randomization until the end of the study at week 52
EMA: PA setting
Tijdsspanne: Measured daily from date of randomization until the end of the study at week 52
Assessed the physical and social setting in which a participant engages in physical activity.
Measured daily from date of randomization until the end of the study at week 52
EMA: Anticipated, remembered, and incidental affect
Tijdsspanne: Measured daily from date of randomization until the end of the study at week 52
Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.
Measured daily from date of randomization until the end of the study at week 52
EMA: Self-Efficacy for Physical Activity
Tijdsspanne: Measured daily from date of randomization until the end of the study at week 52
Measures beliefs about capabilities to be physically active
Measured daily from date of randomization until the end of the study at week 52
EMA: Social Support for Exercise
Tijdsspanne: Measured daily from date of randomization until the end of the study at week 52
Measures a person's social support available to help them exercise
Measured daily from date of randomization until the end of the study at week 52

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Brown University

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: David M Williams, Ph.D., Brown University School of Public Health

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 maart 2022

Primaire voltooiing (Verwacht)

1 mei 2026

Studie voltooiing (Verwacht)

1 mei 2026

Studieregistratiedata

Eerst ingediend

23 februari 2022

Eerst ingediend dat voldeed aan de QC-criteria

15 maart 2022

Eerst geplaatst (Werkelijk)

18 maart 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juli 2022

Laatste update ingediend die voldeed aan QC-criteria

18 juli 2022

Laatst geverifieerd

1 juli 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • R01AG069349 (Subsidie/contract van de Amerikaanse NIH)
  • F32AG074680 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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