Making Healthy Choices: Does Having an Online Health Coach Help?
6 marzo 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
7
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ontario
-
Ottawa, Ontario, Canada, K1N6N5
- University of Ottawa
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 20 anni a 39 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S; Booth, 2000).
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Basic psychological needs satisfaction for physical activity: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Post-intervention (12 weeks)
|
Participants will be asked what they liked, disliked, and experienced during the intervention
|
Post-intervention (12 weeks)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 ottobre 2018
Completamento primario (Effettivo)
30 settembre 2019
Completamento dello studio (Effettivo)
30 settembre 2019
Date di iscrizione allo studio
Primo inviato
27 settembre 2018
Primo inviato che soddisfa i criteri di controllo qualità
28 settembre 2018
Primo Inserito (Effettivo)
1 ottobre 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 marzo 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 marzo 2020
Ultimo verificato
1 marzo 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- H08-18-882
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .