Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study

Titre officiel

StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

Sommaire:

Cet essai de phase III compare une intervention d’activité physique à plusieurs composantes dans le cadre de services de santé mobiles et sur les médias sociaux par rapport au port d’un dispositif de suivi d’activité physique seul chez les adolescents et les jeunes adultes ayant survécu à un cancer infantile. La pratique d’une activité physique régulière contribue à favoriser le maintien d’un poids normal, un niveau d’énergie optimal et une bonne santé. Les adolescents et les jeunes adultes en fin de traitement contre le cancer sont souvent moins actifs. Ils sont plus sujets à la prise de poids et aux problèmes de santé que les personnes du même âge qui n’ont pas été traitées pour un cancer. La comparaison des deux programmes aidera les chercheurs à déterminer comment accroître les niveaux d’activité physique au fil du temps, mais également à comprendre l’incidence des variations dans les niveaux d’activité physique sur la santé et la qualité de vie au fil du temps.

Description de l'essai

Primary Outcome:

• Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation

• Cardiopulmonary fitness
• Body mass index (BMI)
• Resting heart rate
• Health-related quality of life (HRQOL)
• Total cholesterol
• High density lipoprotein (HDL)
• Low density lipoprotein (LDL)
• Triglycerides
• Glucose
• Insulin
• Hemoglobin A1c (HbA1c)
• High sensitivity C-reactive protein (CRP)

PRIMARY OBJECTIVE:

• To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

SECONDARY OBJECTIVES:

• To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.
• To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines.

OUTLINE: Participants are randomized to 1 of 2 groups.

INTERVENTION GROUP: Participants receive educational materials about physical activity.

INTENSIVE PHASE (24 WEEKS): Participants wear a physical activity tracker (Fitbit) daily as well as receiving weekly reminders from study staff to wear it. They also receive goal setting sessions each week (by text, phone call, etc.) to set personalized step count goals using the Fitbit application (app). Lastly, participants receive an invitation to follow and post on an online social media peer support group (Instagram), where study staff provide encouraging advice and messages about physical activity 2-3 times per week, announce badges/awards every week, and moderate a forum to discuss physical activity and use of the Fitbit.

MAINTENANCE PHASE (24 WEEKS): Participants wear a Fitbit daily but do not receive reminders to wear it. They also set their own step count goals weekly and check in with study staff monthly for assistance with goal setting. Participants take the lead posting content on the Instagram account moderated by the study staff. Study staff only post once per week with general physical activity-related questions and provide no badges.

CONTROL GROUP: Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.

Voir cet essai sur ClinicalTrials.gov