- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03691545
Making Healthy Choices: Does Having an Online Health Coach Help?
6. marts 2020 opdateret af: Jennifer Brunet, University of Ottawa
Helping Rural-living Young Adult Cancer Survivors Make Healthy Lifestyle Choices: Does Having a Telehealth Personal Health Coach Help?
Participating in regular physical activity and consuming a diet high in fruits and vegetables can aid in the management of various acute and chronic side effects of cancer treatment; however, few rural-dwelling young adult cancer survivors are active enough and consume enough fruits and vegetables to accrue benefits.
Telehealth interventions show promise for helping these young adults increase their motivation to participate in these behaviours by addressing barriers associated with accessing face-to-face behaviour counselling services (e.g., time commitment, travel distance).
Yet, few researchers have examined the feasibility and acceptability of a telehealth intervention that provides motivational support grounded in self-determination theory for these health behaviours in rural-dwelling young adult cancer survivors.
Based on previous research, the researchers reasoned that rural-dwelling young adult cancer survivors' physical activity and fruit and vegetable consumption would be more likely to increase if they participated in a telehealth intervention therefore, the researchers aim to test the feasibility, acceptability, and preliminary efficacy of the intervention.
The researchers also aim to assess if changes in perceived basic psychological need satisfaction, behaviour regulation, and perceived autonomy support are associated with changes in physical activity and fruit and vegetable consumption.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N6N5
- University of Ottawa
-
-
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
20 år til 39 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Are between the ages of 20-39 years
- Live in a rural area (i.e., areas with <35,000 inhabitants)
- Have completed primary treatment for non-metastatic cancer
- Are not currently meeting the American Cancer Society guidelines for physical activity and fruit and vegetable consumption
- Have access to the Internet and to audio-visual devices
- Are willing to provide informed consent to participate in this study and willing to follow study protocol
- Able to read and understand English
- Are ambulatory
Exclusion Criteria:
- Have a serious condition that precludes safe participation in physical activity
- Have symptomatic heart or vascular diseases (angina, peripheral vascular disease, congestive heart failure)
- Have severe hypertension
- Have had a recent stroke
- Have a chronic obstructive pulmonary disease
- Have severe insulin-dependent diabetes mellitus
- Have renal disease
- Have liver disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group
(1) 12 weekly interactive sessions with a health coach to help them set goals and make changes toward becoming physically active and consuming the recommended number of fruits and vegetables.
|
This arm will receive personalized health coaching (behaviour change counseling)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).
Tidsramme: Baseline (week 0) and post-intervention (week 12)
|
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.
|
Baseline (week 0) and post-intervention (week 12)
|
|
Fruit and vegetable intake behaviour: Behavioural Risk Factor Surveillance System Fruit and Vegetable section (BRFSS-FV; Trowbridge, Wong, Byers, & Serdula, 1990)
Tidsramme: Baseline (week 0) and post-intervention (week 12)
|
Change in self-reported fruit and vegetable intake (over the past 7 days) from baseline to post-intervention, with higher scores representing a better outcome.
|
Baseline (week 0) and post-intervention (week 12)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
Tidsramme: Baseline (week 0) and post-intervention (week 12)
|
Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, using a 1 (false) to 6 (true) scale with higher scores representing a better outcome.
|
Baseline (week 0) and post-intervention (week 12)
|
|
Basic psychological need satisfaction for fruit and vegetable consumption: Psychological Need Satisfaction questionnaire (PNS; Deci, Ryan, Gagne, Leone, Usunov, & Kornazheva, 2001)
Tidsramme: Baseline (week 0) and post-intervention (week 12)
|
Change in basic psychological need satisfaction for fruit and vegetable consumption from baseline to post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
|
Baseline (week 0) and post-intervention (week 12)
|
|
Motivational regulations for physical activity: Exercise Treatment Self-Regulation Questionnaire (TSRQ-E; Williams, Deci, & Ryan, 1998)
Tidsramme: Baseline (week 0) and post-intervention (week 12)
|
Change in motivational regulations for physical activity from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.
|
Baseline (week 0) and post-intervention (week 12)
|
|
Motivational regulations for fruit and vegetable consumption: Dietary Self-Regulation questionnaire (DSR; Williams, Deci, & Ryan, 1998)
Tidsramme: Baseline (week 0) and post-intervention (week 12)
|
Change in motivational regulations for fruit and vegetable consumption from baseline to post-intervention, using a 1 (not at all true) to 7 (very true) scale with higher scores representing a better outcome.
|
Baseline (week 0) and post-intervention (week 12)
|
|
Perceived autonomy support: Health Care Climate Questionnaire (HCCQ; Williams, Grow, Freedman, Ryan, & Deci, 1996)
Tidsramme: Post-intervention (week 12)
|
Level of perceived autonomy support for health behaviours post-intervention, using a 1 (strongly disagree) to 7 (strongly agree) scale with higher scores representing a better outcome.
|
Post-intervention (week 12)
|
|
Recruitment rates
Tidsramme: Duration of recruitment and intervention phase (12 weeks)
|
The number of eligible participants who enrol in the study out of the number assessed for eligibility
|
Duration of recruitment and intervention phase (12 weeks)
|
|
Retention rates for intervention
Tidsramme: Duration of recruitment and intervention phase (12 weeks)
|
The number of participants completing the 12-week intervention.
|
Duration of recruitment and intervention phase (12 weeks)
|
|
Adherence rates for intervention
Tidsramme: Duration of recruitment and intervention phase (12 weeks)
|
The number of eligible participants completing ≥ 70% of the intervention sessions (i.e., 8/12)
|
Duration of recruitment and intervention phase (12 weeks)
|
|
Acceptability of intervention: Semi-structured interviews
Tidsramme: Post-intervention (12 weeks)
|
Participants will be asked what they liked, disliked, and experienced during the intervention
|
Post-intervention (12 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
- Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Deci, E. L., Ryan, R.M., Gagne, M., Leone, D.R., Usunov, J., & Kornazheva, B.P. (2001). Need satisfaction, motivation, and well-being in the work organizations of a former eastern bloc country: A cross-sectional study of self-determination. Journal of Personality and Social Psychology, 27(8), 930-942.
- Trowbridge FL, Wong FL, Byers TE, Serdula MK. Methodological issues in nutrition surveillance: the CDC experience. J Nutr. 1990 Nov;120 Suppl 11:1512-8. doi: 10.1093/jn/120.suppl_11.1512.
- Williams, G. C., Deci, E. L., & Ryan, R. M. (1998). Building health-care partnerships by supporting autonomy: Promoting maintained behavior change and positive health outcomes. In A. L. Suchman, P. Hinton-Walker, & R. Botelho (Ed.), Partnerships in healthcare: Transforming relational process (pp. 67-87). Rochester, NY: University of Rochester Press.
- Wilson, P. M., Rogers, W. T., Rodgers, W. M., & Wild, T. C. (2006). Psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
- Price J, Brunet J. Feasibility and acceptability of a telehealth behavior change intervention for promoting physical activity and fruit and vegetable consumption among rural-living young adult cancer survivors. J Psychosoc Oncol. 2021;39(6):715-733. doi: 10.1080/07347332.2021.1896616. Epub 2021 Apr 2.
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. oktober 2018
Primær færdiggørelse (Faktiske)
30. september 2019
Studieafslutning (Faktiske)
30. september 2019
Datoer for studieregistrering
Først indsendt
27. september 2018
Først indsendt, der opfyldte QC-kriterier
28. september 2018
Først opslået (Faktiske)
1. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- H08-18-882
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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