Clinical trial NCT01975896: Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens
Official title: Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will compare the preliminary efficacy of a novel school-delivered intervention, mindfulness plus health education intervention, to health education alone on dietary and physical activity habits in adolescents. This study has important public health implications because of the negative consequences of unhealthy diets and lack of exercise on health, such as obesity, cardiovascular disease and diabetes. If effective, this intervention has high potential for translation to high school settings

Detailed description: Unhealthy dietary habits and physical inactivity are important modifiable behavioral risk factors for the development of cardiovascular disease. Both behaviors are often established during adolescence and are highly prevalent in teenagers. Conversely, the establishment of healthy dietary and physical activity habits in youth leads to significant health benefits in adulthood, highlighting the need to develop programs aimed at improving dietary and physical activity habits in youth. However, thus far, interventions designed to promote healthy dietary and exercise habits in adolescents have had modest effects on these behaviors, and there is limited knowledge on how to maintain positive changes in these habits over time. Current evidence from observational studies suggests that higher mindfulness levels in adolescents are associated with better eating and exercise habits. In addition, mindfulness is associated with lower impulsivity and better self-control, which are important determinants of healthy behaviors in younger populations. Multiple studies have shown that mindfulness levels increase in response to mindfulness training, and that an increase in mindfulness mediates the effect of mindfulness interventions on health outcomes. Consistent with the goals of PA-11-329 "to determine the influence of complementary and alternative medicine approaches on developing and sustaining healthy behavior habits in children and youth" this multi-PI application seeks to study the role of mindfulness training in promoting and maintaining healthy dietary and physical activity habits. We posit that the addition of mindfulness training to an educational program, compared to an educational program alone, will improve diet and physical activity, and these changes will be maintained over time. In addition, we expect to observe a decrease in impulsivity, indicating that impulsivity may serve as a potential mediator of the effect of the mindfulness intervention on diet and physical activity. This pilot study will test the feasibility and preliminary efficacy of a school-delivered, mindfulness + health education intervention (MHE) compared to health education (HE) alone on dietary habits and physical activity in 80 adolescents recruited among 9th graders (average age, 14) in 2 high schools in Massachusetts; each school will be randomized to either the MHE or HE intervention. Assessments will be performed at baseline, at the end of the intervention (2 months post-baseline), and at 8- months (end of academic year) follow-up. Innovative aspects of this proposal include studying the effect of mindfulness training on health behaviors among youth and the development of a new model linking mindfulness, impulsivity and behavioral change in this population. The study is significant due to the importance of the behaviors targeted and to the potential for translation to high school settings if an effect is demonstrated.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria: (1) enrolled in 9th grade, (2) no prior mindfulness training; (3) English-speaking with at least one English-speaking parent/guardian.

Exclusion Criteria:

* Exclusion Criteria: (1) planning to move out of the area within the next 8 months, (2) unable or unwilling to provide informed assent (adolescent) and parental consent, (3) diagnosis of a serious psychiatric illness during the past 5 years (4) developmental delay that would prevent study participation.

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: One academic year, 8 months
measure: Acceptability of Intervention
timeFrame: One academic year, 8 months
Secondary outcomes:
measure: Preliminary estimates of efficacy
timeFrame: One academic year, 8 months
measure: Explore possible mechanisms of the effect of MHE on diet and physical activity
timeFrame: One academic year, 8 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: Brown University, Providence, RI
name: Elena Salmoirago-Blotcher, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Lori Pbert, PhD
role: PRINCIPAL_INVESTIGATOR
References: