Overweight and ObesityHEARTSNCT04038684
Healthy Eating, Activity and Reduction of Teen Stress
A study of Overweight and Obesity and Overweight Adolescents, run by Kent State University at 1 site in United States.
Trial summary
The goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Overweight and Obesity, Overweight Adolescents, Emotional Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 31 Dec 2022
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13-18 years old
- BMI in the overweight or obese range (≥ 85th%ile for age and sex)
- speak English
Who cannot join
- use of medications that have recently resulted in a change in eating or weight
- cognitive impairment/developmental delay such that study procedures would be inappropriate
- major psychiatric disorder (e.g. clinically severe depression, psychosis, anorexia nervosa, bulimia nervosa)
- current participation in a weight loss program
- pregnant or breastfeeding
- medical condition known to impact weight or that would otherwise prevent participation
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. We aim to examine biological (e.g., weight) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 12-session mindfulness-based weight control intervention compared to a 12-session standard behavioral weight control intervention.
Read the detailed description
The overarching aim of this study is to pilot and refine a novel Mindfulness-Based Weight Control (MBWC) intervention to improve weight management outcomes among adolescents (ages 13-18) who are overweight or obese and from a low-income background. First, we will pilot (open-trial) the MBWC intervention, with a focus on decreasing emotional eating, in an adolescent population. Second, we will conduct a randomized controlled trial of the 12-week MBWC intervention vs. a 12-week standard behavioral weight control intervention among adolescents who are overweight or obese and compare outcomes of the MBWC and control interventions. All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. We are interested in examining change in biological and behavioral variables (e.g., body mass index normed for age and biological sex; perceived stress; eating and activity patterns; psychological function related to weight management) post-intervention and at three-month follow-up. Treatment satisfaction/treatment acceptability will be evaluated at the end of treatment.
- Conditions
- Overweight and Obesity, Overweight Adolescents, Emotional Stress, Stress, Psychological, Eating Behavior
- Being tested
- Mindfulness-Based Weight Control (MBWC), Standard Behavioral Weight Control (SBWC)
- Keywords
- Emotional Eating, Low-income, Mindfulness, Adolescent, Obesity, Weight Management, Stress, Pediatric
- Medical subject headings
- Overweight, Obesity, Stress, Psychological, Feeding Behavior, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Weight Control (MBWC)Behavioural
Mindfulness-Based Weight Control will be administered over 12 group-based sessions with weekly home practice (e.g., mindfulness exercises, dietary self-monitoring, physical activity). All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. Sessions will include BWC and mindfulness components. BWC components include: 1) a dietary plan based on a balanced, caloric deficit diet; 2) increasing physical activity; 3) behavioral components (e.g., self-monitoring, goal setting); and 4) minimal parent involvement (i.e., 3 parent sessions). Participants will be taught core mindfulness exercises (e.g., breath-awareness, body scan, mindful eating) while focusing attention on the present moment and non-judgmentally acknowledging thoughts, emotions, or sensations. Participants will learn informal mindful strategies for daily living, which are designed to increase awareness of emotions and their relation to emotional eating.
Standard Behavioral Weight Control (SBWC)Behavioural
Standard Behavioral Weight Control will be administered over 12 group-based sessions with weekly home activities (dietary self-monitoring, physical activity). All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. Group sessions will include SBWC component, including: 1) a balanced, caloric deficit diet; 2) incrementally increasing physical activity; 3) behavioral components (e.g., self-monitoring, goal setting, motivation, problem-solving, etc.); and 4) minimal parent involvement (i.e., 3 parent sessions).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Weight Control | Experimental | All participants will be randomly assigned to a 12-session group-based Mindfulness-Based Weight Control (MBWC) intervention or a Standard Behavioral Weight Control (SBWC) intervention. Participants assigned to the MBWC intervention will receive mindfulness curriculum informed by Mindfulness-Based Stress Reduction plus the standard behavioral weight control components. Group sessions will be approximately 60 minutes each week. Outside of group sessions, participants will be asked to engage in dietary self-monitoring (MBWC and SBWC groups) and practice mindfulness skills (MBWC only). Receives: Behavioral: Mindfulness-Based Weight Control (MBWC) |
| Standard Behavioral Weight Control | Active comparator | All participants will be randomly assigned to a 12-week group-based Mindfulness-Based Behavioral Weight Control (MBWC) intervention or a Standard Behavioral Weight Control (SBWC) intervention. Participants assigned to the SBWC intervention will receive the SBWC without mindfulness components. Each of the 12 group sessions will be approximately 60 minutes. Outside of group sessions, participants will be asked to practice dietary self-monitoring at home during the week. Receives: Behavioral: Standard Behavioral Weight Control (SBWC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Body Mass Index (BMI)
Objectively measured BMI/BMI z-score/BMI percentile for age and sex;
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Emotional Eating
Emotional Eating Scale for Children (EES-C) total score, which is derived from an average of all 26 items (range = 0-4). Higher scores indicate higher levels of emotional eating.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Perceived Stress
Perceived Stress Scale (PSS) total score, which is derived from summing responses to all 10 items (range = 0-4 per item; 0-40 total). Higher scores indicate higher levels of stress.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Stress
Adolescent Stress Questionnaire (ASQ) total score, which is derived from summing responses to all 58 items (range = 1-5 per item; 58-290 total). Higher scores indicate higher levels of stress.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Chronic Stress
Chronic Stress Questionnaire for Children and Adolescents (CSQ-CA) total score, which is derived from summing responses to all 17 items (range = 1-4 per item; 17-68 total). Higher scores indicate more stress during the past 3 months.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Intervention Acceptability and Feasibility
Acceptability and feasibility of the mindfulness-based behavioral weight control intervention will be measured by session attendance, dietary self-monitoring logs, and attrition rates.
Measured: End of treatment (approx 14 weeks after baseline)
Secondary outcomes (7)
Change in Adolescent Eating Pathology and Symptomology
Youth Eating Disorder Examination-Questionnaire (YEDE-Q) global score, which is derived by averaging the 4 subscales of the YEDE-Q (Restraint, Eating Concern, Shape Concern, and Weight Concern). The range for the total score is 0 to 6, with higher scores indicating more severe eating pathology.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Eating Behaviors
Three Factor Eating Questionnaire (TFEQ), which includes subscales representing uncontrolled eating, cognitive restraint, and emotional eating. Each of the 18 items are rated on a scale of 1-4. Higher scores indicate higher levels of each eating behavior.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Emotion Regulation
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) includes two subscales representing emotion regulation strategies (Suppression and Reappraisal). Responses to all 10 items (range = 1-7 per item) are summed to calculate each subscale. Higher scores indicate higher use of each emotion regulation strategy.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Mindfulness
Child and Adolescent Mindfulness Measure (CAMM) total score, which is derived from reverse scoring and summing responses to all 25 items (range = 0-4 per item; 0-100 total). Higher scores indicate higher acceptance and mindfulness.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Mindful Attention Awareness
Mindfulness Attention Awareness Scale - Adolescent (MAAS-A) total score, which is derived from summing responses to all 15 items (range = 1-6 per item; 15-90 total). Higher scores indicate higher trait mindfulness.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Quality of Life - Adolescent Report
Sizing Me Up total score, which is derived from responses on 22 items (range = 1-4). Raw scores are converted to a scaled score from 0-100, with higher scores indicating greater quality of life.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Quality of Life - Parent/Caregiver Report
Sizing Them Up total score, which is derived from responses on 28 items (range = 1-4). Raw scores are converted to a scaled score from 0-100, with higher scores indicating greater quality of life.
Measured: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start2 Jul 2019
- Primary completion26 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- During the open trial, all participants will receive Mindfulness-Based Behavioral Weight Control (MBWC). During the RCT, participants will be randomly assigned to either MBWC or Standard Behavioral Weight Control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, The Miriam Hospital, Brown University, Rhode Island Hospital, University of North Carolina, Chapel Hill, University of Michigan
- Responsible party
- Principal investigator, Amy Sato, Kent State University
- Investigators
- Amy F Sato, PhD, Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038684
- Sponsor's protocol ID
- 19-201
- Acronym
- HEARTS
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2019
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating, Activity and Reduction of Teen Stress
- ClinicalTrials.gov ID
- NCT04038684
- Acronym / sponsor ID
- HEARTS / 19-201
- Conditions
- Overweight and Obesity, Overweight Adolescents, Emotional Stress, Stress, Psychological, Eating Behavior
- Keywords
- Emotional Eating, Low-income, Mindfulness, Adolescent, Obesity, Weight Management, Stress, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- Case Western Reserve University, The Miriam Hospital, Brown University, Rhode Island Hospital, University of North Carolina, Chapel Hill, University of Michigan
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 26 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Jul 2019 (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.
The goal of this study is to develop and pilot test a telehealth behavioral weight control intervention for adolescents from a low-income background that combines facets of mindfulness training with behavioral weight control. We aim to examine biological (e.g., weight) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 12-session mindfulness-based weight control intervention compared to a 12-session standard behavioral weight control intervention.
Detailed description
The overarching aim of this study is to pilot and refine a novel Mindfulness-Based Weight Control (MBWC) intervention to improve weight management outcomes among adolescents (ages 13-18) who are overweight or obese and from a low-income background. First, we will pilot (open-trial) the MBWC intervention, with a focus on decreasing emotional eating, in an adolescent population. Second, we will conduct a randomized controlled trial of the 12-week MBWC intervention vs. a 12-week standard behavioral weight control intervention among adolescents who are overweight or obese and compare outcomes of the MBWC and control interventions. All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. We are interested in examining change in biological and behavioral variables (e.g., body mass index normed for age and biological sex; perceived stress; eating and activity patterns; psychological function related to weight management) post-intervention and at three-month follow-up. Treatment satisfaction/treatment acceptability will be evaluated at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- During the open trial, all participants will receive Mindfulness-Based Behavioral Weight Control (MBWC). During the RCT, participants will be randomly assigned to either MBWC or Standard Behavioral Weight Control.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Weight Control | Experimental | Behavioral: Mindfulness-Based Weight Control (MBWC)All participants will be randomly assigned to a 12-session group-based Mindfulness-Based Weight Control (MBWC) intervention or a Standard Behavioral Weight Control (SBWC) intervention. Participants assigned to the MBWC intervention will receive mindfulness curriculum informed by Mindfulness-Based Stress Reduction plus the standard behavioral weight control components. Group sessions will be approximately 60 minutes each week. Outside of group sessions, participants will be asked to engage in dietary self-monitoring (MBWC and SBWC groups) and practice mindfulness skills (MBWC only). |
| Standard Behavioral Weight Control | Active comparator | Behavioral: Standard Behavioral Weight Control (SBWC)All participants will be randomly assigned to a 12-week group-based Mindfulness-Based Behavioral Weight Control (MBWC) intervention or a Standard Behavioral Weight Control (SBWC) intervention. Participants assigned to the SBWC intervention will receive the SBWC without mindfulness components. Each of the 12 group sessions will be approximately 60 minutes. Outside of group sessions, participants will be asked to practice dietary self-monitoring at home during the week. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 13-18 years old
- BMI in the overweight or obese range (≥ 85th%ile for age and sex)
- speak English
Key exclusion criteria (6 listed)
- use of medications that have recently resulted in a change in eating or weight
- cognitive impairment/developmental delay such that study procedures would be inappropriate
- major psychiatric disorder (e.g. clinically severe depression, psychosis, anorexia nervosa, bulimia nervosa)
- current participation in a weight loss program
- pregnant or breastfeeding
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 |
|---|---|---|
| Mindfulness-Based Weight Control (MBWC)Mindfulness-Based Weight Control will be administered over 12 group-based sessions with weekly home practice (e.g., mindfulness exercises, dietary self-monitoring, physical activity). All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. Sessions will include BWC and mindfulness components. BWC components include: 1) a dietary plan based on a balanced, caloric deficit diet; 2) increasing physical activity; 3) behavioral components (e.g., self-monitoring, goal setting); and 4) minimal parent involvement (i.e., 3 parent sessions). Participants will be taught core mindfulness exercises (e.g., breath-awareness, body scan, mindful eating) while focusing attention on the present moment and non-judgmentally acknowledging thoughts, emotions, or sensations. Participants will learn informal mindful strategies for daily living, which are designed to increase awareness of emotions and their relation to emotional eating. | Behavioural | Mindfulness-Based Weight Control |
| Standard Behavioral Weight Control (SBWC)Standard Behavioral Weight Control will be administered over 12 group-based sessions with weekly home activities (dietary self-monitoring, physical activity). All components of this telehealth intervention will be delivered via HIPAA-compliant videoconferencing software. Group sessions will include SBWC component, including: 1) a balanced, caloric deficit diet; 2) incrementally increasing physical activity; 3) behavioral components (e.g., self-monitoring, goal setting, motivation, problem-solving, etc.); and 4) minimal parent involvement (i.e., 3 parent sessions). | Behavioural | Standard Behavioral Weight Control |
Primary outcome
Change in Adolescent Body Mass Index (BMI)
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Objectively measured BMI/BMI z-score/BMI percentile for age and sex;
Change in Adolescent Emotional Eating
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Emotional Eating Scale for Children (EES-C) total score, which is derived from an average of all 26 items (range = 0-4). Higher scores indicate higher levels of emotional eating.
Change in Adolescent Perceived Stress
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Perceived Stress Scale (PSS) total score, which is derived from summing responses to all 10 items (range = 0-4 per item; 0-40 total). Higher scores indicate higher levels of stress.
Change in Adolescent Stress
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Adolescent Stress Questionnaire (ASQ) total score, which is derived from summing responses to all 58 items (range = 1-5 per item; 58-290 total). Higher scores indicate higher levels of stress.
Change in Adolescent Chronic Stress
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Chronic Stress Questionnaire for Children and Adolescents (CSQ-CA) total score, which is derived from summing responses to all 17 items (range = 1-4 per item; 17-68 total). Higher scores indicate more stress during the past 3 months.
Intervention Acceptability and Feasibility
Time frame: End of treatment (approx 14 weeks after baseline)
Acceptability and feasibility of the mindfulness-based behavioral weight control intervention will be measured by session attendance, dietary self-monitoring logs, and attrition rates.
7 secondary outcomes
Change in Adolescent Eating Pathology and Symptomology
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Eating Behaviors
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Emotion Regulation
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Mindfulness
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Mindful Attention Awareness
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Quality of Life - Adolescent Report
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Change in Adolescent Quality of Life - Parent/Caregiver Report
Time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
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 3 May 2023.
- Individual participant dataSharing planned: No
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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.
Amy F Sato, PhD principal investigator
Kent State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overweight and Obesity and Overweight Adolescents, run by Kent State University 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 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 3 May 2023. 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?
Change in Adolescent Body Mass Index (BMI) (time frame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.). The study lists 6 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 3 May 2023.