Pediatric ObesityNCT03611660
Does Mindfulness Enhance BMI in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
A study testing Traditional Healthy Lifestyle Program and Mindfulness Meditation Instruction in people with Pediatric Obesity, run by Yale University at 2 sites in United States.
Trial summary
Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Traditional Healthy Lifestyle Program and Mindfulness Meditation Instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jan 2018to 30 Mar 2021
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI >95th percentile for gender \& age
- English-speaking subject and parent/caregiver
- Parent/caregiver willing to participate in weight mgt program
Who cannot join
- BMI >40 <27
- Psychiatric disorder or medical condition that precludes participation in program
- Currently taking medication that causes weight gain or loss
- Involvement in co-existing weight management program
- A positive pregnancy test
- Plans on moving out of the Greater New Haven area within 9 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Center for Clinical Investigation
New Haven, Connecticut, 06520
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Does the Addition of Mindfulness Enhance BMI Outcomes in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.
Read the detailed description
The study will randomize 44 adolescents (aged 11-17 yo) with BMI >95th percentile to traditional Bright Bodies Healthy Lifestyle Program or Lifestyle Program plus mindfulness meditation (6 sessions within the 12-week program) (22 per group). The traditional program includes exercise two evenings per week and nutrition/behavior modification one evening per week for 12 weeks. Mindfulness session topics include breathing meditation, body scan meditation, mindful eating techniques, and identification of hunger verses satiation. The primary outcome measure with be (1) BMI, while secondary outcomes include changes in (2) percent body fat, (3) perceived stress scale (questionnaire), (4) physical stress (saliva cortisol levels), and (5) overall caloric intake (pre and post food records). After the 3 month intervention, participants will engage in post measures and be asked to return 6 months later (9 months) for longer-term follow-up measures.
- Conditions
- Pediatric Obesity
- Being tested
- Traditional Healthy Lifestyle Program, Mindfulness Meditation Instruction
- Keywords
- pediatric obesity, stress
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Healthy Lifestyle ProgramBehavioural
Twice weekly meetings that focus on nutrition and exercise for 12 weeks.
Mindfulness Meditation InstructionBehavioural
Participants receive six mindfulness sessions.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Lifestyle Program ONLY | Active comparator | Participants will receive an evidence-based 12-week family-based pediatric obesity program. Receives: Behavioral: Traditional Healthy Lifestyle Program |
| Traditional Lifestyle Program PLUS Mindfulness | Experimental | Participants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction. Receives: Behavioral: Traditional Healthy Lifestyle Program; Behavioral: Mindfulness Meditation Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
Measured: Change from baseline at 12 weeks
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
Measured: Change from baseline at 9 months
Secondary outcomes (12)
Percent Body Fat
Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.
Measured: Change from baseline at 12 weeks
Percent Body Fat
Tanita Body Fat Analyzer uses a foot-to-foot bioelectrical impedence to capture participant's percent body fat.
Measured: Change from baseline at 9 months
Perceived Stress Scale
The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item likert questionnaire published by Mind Garden that asks about feelings and thoughts during the last month. PSS scores are obtained by reversing responses (i.e., 0=4) for positively stated items and leaving score as is for negatively stated items. An average score for this age group is 14.2, with higher scores indicating more stress. Our hypothesis is a greater change (lower scores at post) in the mindfulness group + traditional than traditional group alone.
Measured: Change from baseline at 12 weeks
Perceived Stress Scale
The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item likert questionnaire published by Mind Garden that asks about feelings and thoughts during the last month. PSS scores are obtained by reversing responses (i.e., 0=4) for positively stated items and leaving score as is for negatively stated items. An average score for this age group is 14.2, with higher scores indicating more stress. Our hypothesis is a greater change (lower scores at post) in the mindfulness group + traditional than traditional group alone.
Measured: Change from baseline at 9 months
Physical Stress
A physical indicator of stress is measured by saliva cortisol. We are using saliva swabs by Salimetrics. A normal range for saliva cortisol is 0.007-0.115 mcg/dL. Our hypothesis is a greater change (lowered) in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 12 weeks
Physical Stress
A physical indicator of stress is measured by saliva cortisol. We are using saliva swabs by Salimetrics. A normal range for saliva cortisol is 0.007-0.115 mcg/dL. Our hypothesis is a greater change (lowered) in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 9 months
Caloric Intake
Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 12 weeks
Fat Intake
Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 12 weeks
Sugar Intake
Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 12 weeks
Caloric Intake
Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 9 months
Fat Intake
Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 9 months
Sugar Intake
Calories, fat (grams), and added sugar (grams) will be measured by a 3-day food record entered into our Nutrition Data Software for Research (NDSR) Program. We will measure change and our hypothesis is that kcal, fat, and added sugar will be lower in the mindfulness + traditional group than the traditional group alone.
Measured: Change from baseline at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start11 Jan 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Friends of Yale New Haven Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611660
- Sponsor's protocol ID
- 2000021532
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2018
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Mindfulness Enhance BMI Outcomes in Obese Adolescents Enrolled in the Bright Bodies Weight Management Program?
- ClinicalTrials.gov ID
- NCT03611660
- Acronym / sponsor ID
- 2000021532
- Conditions
- Pediatric Obesity
- Keywords
- pediatric obesity, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Friends of Yale New Haven Children's Hospital
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 2 Aug 2018 (actual)
- 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.
Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.
Detailed description
The study will randomize 44 adolescents (aged 11-17 yo) with BMI >95th percentile to traditional Bright Bodies Healthy Lifestyle Program or Lifestyle Program plus mindfulness meditation (6 sessions within the 12-week program) (22 per group). The traditional program includes exercise two evenings per week and nutrition/behavior modification one evening per week for 12 weeks. Mindfulness session topics include breathing meditation, body scan meditation, mindful eating techniques, and identification of hunger verses satiation. The primary outcome measure with be (1) BMI, while secondary outcomes include changes in (2) percent body fat, (3) perceived stress scale (questionnaire), (4) physical stress (saliva cortisol levels), and (5) overall caloric intake (pre and post food records). After the 3 month intervention, participants will engage in post measures and be asked to return 6 months later (9 months) for longer-term follow-up measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Traditional Lifestyle Program ONLY | Active comparator | Behavioral: Traditional Healthy Lifestyle ProgramParticipants will receive an evidence-based 12-week family-based pediatric obesity program. |
| Traditional Lifestyle Program PLUS Mindfulness | Experimental | Behavioral: Traditional Healthy Lifestyle Program, Behavioral: Mindfulness Meditation InstructionParticipants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI >95th percentile for gender \& age
- English-speaking subject and parent/caregiver
- Parent/caregiver willing to participate in weight mgt program
Key exclusion criteria (6 listed)
- BMI >40 <27
- Psychiatric disorder or medical condition that precludes participation in program
- Currently taking medication that causes weight gain or loss
- Involvement in co-existing weight management program
- A positive pregnancy test
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 |
|---|---|---|
| Traditional Healthy Lifestyle ProgramTwice weekly meetings that focus on nutrition and exercise for 12 weeks. | Behavioural | Traditional Lifestyle Program ONLY, Traditional Lifestyle Program PLUS Mindfulness |
| Mindfulness Meditation InstructionParticipants receive six mindfulness sessions. | Behavioural | Traditional Lifestyle Program PLUS Mindfulness |
Primary outcome
Body Mass Index (BMI)
Time frame: Change from baseline at 12 weeks
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
Body Mass Index (BMI)
Time frame: Change from baseline at 9 months
Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703
12 secondary outcomes
Percent Body Fat
Time frame: Change from baseline at 12 weeks
Percent Body Fat
Time frame: Change from baseline at 9 months
Perceived Stress Scale
Time frame: Change from baseline at 12 weeks
Perceived Stress Scale
Time frame: Change from baseline at 9 months
Physical Stress
Time frame: Change from baseline at 12 weeks
Physical Stress
Time frame: Change from baseline at 9 months
Caloric Intake
Time frame: Change from baseline at 12 weeks
Fat Intake
Time frame: Change from baseline at 12 weeks
Sugar Intake
Time frame: Change from baseline at 12 weeks
Caloric Intake
Time frame: Change from baseline at 9 months
Fat Intake
Time frame: Change from baseline at 9 months
Sugar Intake
Time frame: Change from baseline at 9 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 11 Jun 2021.
- weight management program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Healthy Lifestyle Program and Mindfulness Meditation Instruction in people with Pediatric Obesity, run by Yale University at 2 sites 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 3 inclusion and 6 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 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Body Mass Index (BMI) (time frame: Change from baseline at 12 weeks). 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 11 Jun 2021.