Aging Clinical Trial
Official title:
Gaming Applied to the Promotion of Active Aging
Active aging programs have been recommended by the World Health Organization to help deal
with the progressive aging of the population. However, older adults have difficulties in
accessing these programs. Online video game-based interventions would improve their
accessibility, while complementing these interventions with a mobile application (App) would
increase adherence and professional monitoring. The main objective of this study is to assess
the efficacy of an interactive, online, video game-based cognitive behavioral intervention
with an App companion for active aging compared to a control group receiving therapeutically
inactive information. The secondary objectives are to: (a) analyze the moderators of the
change in the outcome variables and (b) evaluate adherence to the intervention.
A randomized controlled trial will be performed including healthy adults older than 44.
Recruitment of 180 participants is planned, with random allocation to one of the two
conditions (90 participants per group): (a) an experimental group receiving an interactive,
online, multimedia, video game-based cognitive behavioral intervention with an App companion
(CCI-V) or (b) a control group receiving online therapeutically inactive information about
active aging (CG).
The intervention will be administered in 8 weekly modules comprised of 45-minute sessions. A
blind evaluation will be conducted through online self-administered tests at baseline,
post-intervention, and 6- and 12-month follow-up. The primary outcome will be the health
status. Secondary outcomes will be emotional well-being, symptoms of depression,
reinforcement, negative thoughts, self-reported memory, cognitive tasks, sleep hygiene,
physical activity, eating habits, body mass index (BMI), social support, dropouts, treatment
adherence, and satisfaction with the intervention.
European population aging has increased in the last several decades: 19.1% of Europeans are
currently older than 65, and 39.2% are over 50. Depression and dementia are some of the most
prevalent conditions in older adults, and both have high socioeconomic costs. In this
context, the World Health Organization has pointed out the importance of active aging
promotion programs to help older adults maintain their independence and health for longer. In
addition, healthy life habits such as physical activity and eating a balanced diet also help
prevent disease and preserve mental and physical functions.
However, the lack of health care services for older adults, especially in rural areas which
tend to have more older people, may limit access to active aging programs targeting
depression, cognitive decline, and healthy habits. One way to overcome these barriers is
through online video games that are accessible at home at any time with a low cost. However,
the efficacy of video games in promoting active aging from middle to late adulthood has
received very little attention in the literature.
A meta-analysis of 21 randomized controlled trials about video game-based interventions
administered to healthy adults over 44 found that video game-based interventions produced
positive effects on negative affect, objectively measured physical and social health with
small effect sizes. However, the reviewed studies used non-standardized measures, and
follow-ups were scarce. There was only one video game designed to prevent depression in older
people. Furthermore, none of the reviewed studies involved integral interventions for
emotional wellbeing, cognitive stimulation, or healthy life habits, even though a review of
modifiable risk factors for dementia estimated that 51% of population-attributable risk was
associated with cognitive inactivity, depression, physical inactivity, and obesity; and these
midlife risk factors could be tackled early to prevent or delay the onset of dementia.
This study will assess the efficacy of an interactive, online, video game-based cognitive
behavioral intervention to promote active aging from an integral health perspective,
targeting emotional well-being, cognition, healthy life habits (sleep hygiene, physical
activity, and eating habits), and social support.
Randomization will occur after screening and baseline assessments. An independent researcher
(allocation concealment) will make allocation cards using computer-generated random numbers.
He will keep the original random allocation sequences in an inaccessible location and will
work with a copy. The randomization sequence will be communicated to the researchers in
sealed numbered envelopes, one for each participant, with instructions to use them in
numerical order.
Sample size calculation: We estimate that a sample size of 78 participants per group will be
required, based on a previous meta-analysis of video game-based interventions for active
aging reported effect sizes for mood and objectively measured physical health of 0.26 and
0.34, respectively, and another meta-analysis of video games for training cognition in older
adults reported an effect size of 0.37, and assuming 80% power at a 0.05 (two-tailed)
significance level and a mean of 8% attrition. To safeguard against an estimated 12% to 15%
loss to follow-up, a minimum of 180 participants (90 in each group) must be recruited.
Ethics: Ethics approval has been obtained from the Bioethics Committee of the University of
Santiago de Compostela (Spain), and the project complies with the Declaration of Helsinki.
The confidentiality of all participants will be guaranteed. Participants will have to give
their informed consent, which has been approved by the Bioethics Committee of the University
of Santiago de Compostela (Spain).
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