- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03691545
Making Healthy Choices: Does Having an Online Health Coach Help?
6 maart 2020 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
7
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N6N5
- University of Ottawa
-
-
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
20 jaar tot 39 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
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: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).
Tijdsspanne: 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)
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Post-intervention (12 weeks)
|
Participants will be asked what they liked, disliked, and experienced during the intervention
|
Post-intervention (12 weeks)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
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)
1 oktober 2018
Primaire voltooiing (Werkelijk)
30 september 2019
Studie voltooiing (Werkelijk)
30 september 2019
Studieregistratiedata
Eerst ingediend
27 september 2018
Eerst ingediend dat voldeed aan de QC-criteria
28 september 2018
Eerst geplaatst (Werkelijk)
1 oktober 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
6 maart 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- H08-18-882
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .