OverweightNCT01975896
Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens
A study testing Meditation in people with Overweight and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria: (1) enrolled in 9th grade, (2) no prior mindfulness training; (3) English-speaking with at least one English-speaking parent/guardian.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Meditation
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own
| Study group | Role | What they receive |
|---|---|---|
| Meditation | Experimental | The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own Receives: Behavioral: Meditation |
| Health Education | No intervention | The health education curriculum will be informed by: 1) the dietary and PA didactic units and materials developed as part of our school based trial, adapted for adolescents from the Diabetes Prevention Program (DPP) and 2) the standard curricula for school-based health education programs with particular attention to the unique needs of adolescents:increasing fruits and vegetables, reducing sugar sweetened drinks, and decreasing foods high in fat, unhealthy carbohydrates, and calories. The PA component will be based on current recommendations of engaging in at least 1 hour of moderate-to-vigorous physical activity (MVPA) most days of the week, building PA into the teen's lifestyle,and reducing sedentary behavior. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention
We will be able to recruit 80 adolescents (40 per condition) within the specified time frame, and no more than 20% will drop out of the study.
Measured: One academic year, 8 months
Acceptability of Intervention
Program evaluations for both conditions will show overall positive comments and at least 80% of participants will indicate high acceptability ratings.
Measured: One academic year, 8 months
Secondary outcomes (2)
Preliminary estimates of efficacy
The MHE group, compared to HE, will have greater changes in calorie, saturated fat intake and fruit and vegetable intake, and in physical activity at the end of intervention; these changes will be maintained over time (8-month follow-up). Additional outcomes will include BMI, sedentary behavior, and quality of life.
Measured: One academic year, 8 months
Explore possible mechanisms of the effect of MHE on diet and physical activity
The MHE intervention, compared to HE, will increase mindfulness; higher mindfulness will be associated with a decrease in impulsivity; and the decrease in impulsivity will be positively associated with changes in diet and physical activity.
Measured: One academic year, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Pbert, University of Massachusetts, Worcester
- Investigators
- Elena Salmoirago-Blotcher, PhD, MD, Principal investigator, Brown University, Providence, RILori Pbert, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975896
- Sponsor's protocol ID
- R21H119665
- Status last verified
- Jul 2015
- First submitted
- 28 Oct 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training to Promote Healthy Diet and Physical Activity in Teens
- ClinicalTrials.gov ID
- NCT01975896
- Acronym / sponsor ID
- R21H119665
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation | Experimental | Behavioral: MeditationThe intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own |
| Health Education | No intervention | –The health education curriculum will be informed by: 1) the dietary and PA didactic units and materials developed as part of our school based trial, adapted for adolescents from the Diabetes Prevention Program (DPP) and 2) the standard curricula for school-based health education programs with particular attention to the unique needs of adolescents:increasing fruits and vegetables, reducing sugar sweetened drinks, and decreasing foods high in fat, unhealthy carbohydrates, and calories. The PA component will be based on current recommendations of engaging in at least 1 hour of moderate-to-vigorous physical activity (MVPA) most days of the week, building PA into the teen's lifestyle,and reducing sedentary behavior. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inclusion criteria: (1) enrolled in 9th grade, (2) no prior mindfulness training; (3) English-speaking with at least one English-speaking parent/guardian.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationThe intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own | Behavioural | Meditation |
Primary outcome
Feasibility of the Intervention
Time frame: One academic year, 8 months
We will be able to recruit 80 adolescents (40 per condition) within the specified time frame, and no more than 20% will drop out of the study.
Acceptability of Intervention
Time frame: One academic year, 8 months
Program evaluations for both conditions will show overall positive comments and at least 80% of participants will indicate high acceptability ratings.
2 secondary outcomes
Preliminary estimates of efficacy
Time frame: One academic year, 8 months
Explore possible mechanisms of the effect of MHE on diet and physical activity
Time frame: One academic year, 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Salmoirago-Blotcher, PhD, MD principal investigator
Brown University, Providence, RI
Lori Pbert, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Overweight and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: One academic year, 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2015.