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

April 30, 2023 updated by: Amy Sato, Kent State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Amy F Sato, PhD
  • Phone Number: (330) 672-4888
  • Email: asato2@kent.edu

Study Contact Backup

  • Name: Caroline E West, MA
  • Phone Number: (330) 672-2231
  • Email: cwest30@kent.edu

Study Locations

  • United States
    • Ohio
      • Kent, Ohio, United States, 44242
        • Kent State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 13-18 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness-Based Weight Control
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).
Behavioral: 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.
Active Comparator: Standard Behavioral Weight Control
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.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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;
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
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.
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
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.
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
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.
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
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.
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
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.
End of treatment (approx 14 weeks after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kent State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Brown University
The Miriam Hospital
University of Michigan
University of North Carolina, Chapel Hill
Rhode Island Hospital
Case Western Reserve University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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