Healthy Eating, Activity and Reduction of Teen Stress

NCT04038684 | Completed DMC

• 1 other identifier: 19-201
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Overweight and Obesity; Overweight Adolescents; Emotional Stress; Stress, Psychological; Eating Behavior

Keywords

Emotional Eating; Low-income; Mindfulness; Adolescent; Obesity; Weight Management; Stress; Pediatric

Outcome Measures

Primary Outcomes (6)

• Change in Adolescent Body Mass Index (BMI)

  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

  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

  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

  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

  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

  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 Outcomes (7)

• Change in Adolescent Eating Pathology and Symptomology

  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

  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

  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

  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

  baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.

Study Arms (2)

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).

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.

Behavioral: Standard Behavioral Weight Control (SBWC)

Interventions

Mindfulness-Based Weight Control (MBWC) BEHAVIORAL

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.

Mindfulness-Based Weight Control

Standard Behavioral Weight Control (SBWC) BEHAVIORAL

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).

Standard Behavioral Weight Control

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• BMI in the overweight or obese range (≥ 85th%ile for age and sex)
• speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• Kent State University: lead
• Case Western Reserve University: collaborator
• The Miriam Hospital: collaborator
• Brown University: collaborator
• Rhode Island Hospital: collaborator
• University of North Carolina, Chapel Hill: collaborator
• University of Michigan: collaborator

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Stress, Psychological; Feeding Behavior; Emotional Eating

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Behavior, Animal

Study Officials

• Amy F Sato, PhD

  Kent State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychological Sciences

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 31, 2019
• Study Start: July 2, 2019
• Primary Completion: December 26, 2022
• Study Completion: December 31, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)