Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Healthy Eating, Activity and Reduction of Teen Stress (HEARTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038684
Recruitment Status : Suspended (Recruitment suspended as of March 16, 2020 due to COVID-19 pandemic)
First Posted : July 31, 2019
Last Update Posted : April 14, 2020
Sponsor:
Collaborators:
Case Western Reserve University
The Miriam Hospital
Brown University
Rhode Island Hospital
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Amy Sato, Kent State University

Brief Summary:
The goal of this study is to develop and pilot test a 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, stress hormone) and behavioral (e.g., emotional eating, mindfulness) changes as a result of a 16-session mindfulness-based weight control intervention compared to a 16-session standard behavioral weight control intervention.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Overweight Adolescents Emotional Stress Stress, Psychological Eating Behavior Behavioral: Mindfulness-Based Weight Control (MBWC) Behavioral: Standard Behavioral Weight Control (SBWC) Not Applicable

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 13-17) who are overweight or obese and from a low-income background. First, we will pilot (open-trial) the 16-session MBWC intervention, with a focus on decreasing emotional eating, in an adolescent population. Second, we will conduct a randomized controlled trial of the 16-week MBWC intervention vs. a 16-week standard behavioral weight control intervention among adolescents who are overweight or obese and compare outcomes of the MBWC and control interventions. We are interested in examining change in biological and behavioral variables (e.g., body mass index normed for age and biological sex; perceived stress; physiological stress biomarkers; 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healthy Eating, Activity and Reduction of Teen Stress
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Mindfulness-Based Weight Control
All participants will be randomly assigned to a 16-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 90 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).
Behavioral: Mindfulness-Based Weight Control (MBWC)
Mindfulness-Based Weight Control will be administered over 16 group-based sessions with weekly home practice (mindfulness exercises, dietary self-monitoring, physical activity). Sessions will include Standard Behavioral Weight Control (SBWC) and mindfulness components. SBWC components include: 1) a dietary plan based on a balanced, reduced caloric deficit diet; 2) incrementally increasing physical activity; 3) behavioral components (e.g. self-monitoring, goal setting, stimulus control); 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 pleasant and unpleasant emotions and the relation to habitual behaviors (e.g. emotional eating).

Active Comparator: Standard Behavioral Weight Control
All participants will be randomly assigned to a 16-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 16 group sessions will be approximately 90 minutes. Outside of group sessions, participants will be asked to practice dietary self-monitoring at home during the week.
Behavioral: Standard Behavioral Weight Control (SBWC)
Standard Behavioral Weight Control will be administered over 16 group-based sessions with weekly home activities (dietary self-monitoring, physical activity). Group sessions will include SBWC component, including: 1) a balanced, reduced caloric deficit diet; 2) incrementally increasing physical activity; 3) behavioral components (e.g., self-monitoring, goal setting, stimulus control, motivation, problem-solving, etc.); and 4) minimal parent involvement (i.e., 3 parent sessions).




Primary Outcome Measures :
  1. Change in Adolescent Body Mass Index (BMI) [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Objectively measured BMI/BMI z-score/BMI percentile for age and sex;

  2. Change in Adolescent Emotional Eating [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 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.

  3. Change in Adolescent Stress Biomarkers [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Diurnal Salivary Cortisol; Salivary α-amylase (sAA)

  4. Change in Adolescent Perceived Stress [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 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.

  5. Change in Adolescent Stress [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 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.

  6. Change in Adolescent Chronic Stress [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 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.

  7. Intervention Acceptability and Feasibility [ Time Frame: End of treatment (up to 18 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.


Secondary Outcome Measures :
  1. Change in Adolescent Loss of Control Eating Behaviors [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Child Eating Disorder Examination (ChEDE) frequency of loss of control eating episodes (objectively and subjectively large episodes of overeating while feeling a sense of loss of control).

  2. Change in Adolescent Eating Pathology and Symptomology [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  3. Change in Adolescent Eating Behaviors [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  4. Change in Adolescent Binge Eating Behaviors [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Binge Eating Scale (BES) total score, which is derived from summing the predetermined scoring weights to responses on all 16 items (range = 0-3 per item; 0-46 total). Higher scores indicate more binge eating behaviors.

  5. Change in Adolescent Neurocognitive Functioning [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    NIH Toolbox Cognitive Battery, which includes the following tests: Flanker Inhibitory Control and Attention, Dimensional Change Card Sort, List Sorting Working Memory, Pattern Comparison Processing Speed, Picture Sequence Memory, and Picture Vocabulary. All scores are normed with a mean of 100 and standard deviation of 15. Higher scores indicate higher cognitive functioning ability.

  6. Change in Adolescent Emotion Regulation [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  7. Change in Adolescent Mindfulness [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  8. Change in Adolescent Psychological Inflexibility [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Avoidance and Fusion Questionnaire for Youth (AFQ-Y) total score, which is derived from summing responses to all 17 items (range = 0-4 per item; 0-68 total). Higher scores indicate greater psychological inflexibility.

  9. Change in Adolescent Mindful Attention Awareness [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  10. Change in Adolescent Quality of Life - Adolescent Report [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  11. Change in Adolescent Quality of Life - Parent/Caregiver Report [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    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.

  12. Change in Adolescent Anxiety - Adolescent Report [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Multidimensional Anxiety Scale for Children 2nd Edition (MASC2) total score, which is derived by summing responses to all 39 items (range = 0-3 per item) and converted into T-scores (range = 25-90). Higher scores indicate greater levels of anxiety.

  13. Change in Adolescent Anxiety - Parent/Caregiver Report [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Multidimensional Anxiety Scale for Children 2nd Edition (MASC2) Parent total score, which is derived by summing responses to all 39 items (range = 0-3 per item) and converted into T-scores (range = 25-90). Higher scores indicate greater levels of anxiety.

  14. Change in Adolescent Internalizing Symptoms - Adolescent Report [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Youth Self-Report for Ages 11-18 years internalizing subscale which is based on responses to items on the 112-item Youth Self-Report that correspond to internalizing symptoms (range = 0-2 per item). Higher scores indicate higher more internalizing symptoms.

  15. Change in Adolescent Internalizing Symptoms - Parent/Caregiver Report [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Child Behavior Checklist (CBCL) for ages 6-18, Parent-Report internalizing subscale which is derived from summing responses to 32 items (range = 0-2 per item; 0-64 total). Higher scores indicate higher more internalizing symptoms.

  16. Change in Adolescent Self-Esteem [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Rosenberg Self-Esteem Scale (RSES) total score, which is derived from summing responses to all 10 items (range = 1-4 per item; 10-40 total). Higher scores indicate greater self-esteem.

  17. Change in Adolescent Weight-Related Self-Efficacy [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Weight Efficacy Lifestyle Questionnaire (WEL) total score, which is derived from an average of all 20 items (range = 0-9). Higher scores indicate higher levels of weight-related self-efficacy .

  18. Change in Adolescent Rumination [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Ruminative Response Scale for Adolescents (RSS-A) total score, which is derived by summing responses to all 22 items (range = 1-4 per item; 22-88 total). Higher scores indicate a greater ruminative response style.

  19. Change in Adolescent Depression [ Time Frame: baseline to intervention completion (approx 18 weeks), baseline to 3-month follow-up (approx 30 weeks), and intervention completion to 3-month follow-up. ]
    Reynolds Adolescent Depression Scale, 2nd Edition (RADS-2) total score, which is derived by summing responses to all 30 items (range = 1-4 per item). Higher scores indicate greater levels of depressive symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 13-17 years old
  2. BMI in the overweight or obese range (≥ 85th%ile for age and sex)
  3. speak English

Exclusion Criteria:

  1. use of medications that have recently resulted in a change in eating or weight
  2. cognitive impairment/developmental delay such that study procedures would be inappropriate
  3. major psychiatric disorder (e.g. clinically severe depression, psychosis, anorexia nervosa, bulimia nervosa)
  4. current participation in a weight loss program
  5. pregnant or breastfeeding
  6. medical condition known to impact weight or that would otherwise prevent participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038684


Locations
Layout table for location information
United States, Ohio
Kent State University
Kent, Ohio, United States, 44242
Sponsors and Collaborators
Kent State University
Case Western Reserve University
The Miriam Hospital
Brown University
Rhode Island Hospital
University of North Carolina, Chapel Hill
Investigators
Layout table for investigator information
Principal Investigator: Amy F Sato, PhD Kent State University
Layout table for additonal information
Responsible Party: Amy Sato, Associate Professor of Psychological Sciences, Kent State University
ClinicalTrials.gov Identifier: NCT04038684    
Other Study ID Numbers: 19-201
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Sato, Kent State University:
Emotional Eating
Low-income
Stress Biomarkers
Mindfulness
Adolescent
Obesity
Weight Management
Stress
Pediatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Stress, Psychological
Body Weight
Signs and Symptoms
Behavioral Symptoms