Healthy Eating, Activity and Reduction of Teen Stress

NCT04038684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2023-05-03

No results posted yet for this study

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

Interventions

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.

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).

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER
  • The Miriam Hospital

    collaborator OTHER
  • Brown University

    collaborator OTHER
  • Rhode Island Hospital

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • University of Michigan

    collaborator OTHER
  • Kent State University

    lead OTHER

Principal Investigators

  • Amy F Sato, PhD · Kent State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-02
Primary Completion
2022-12-26
Completion
2022-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04038684 on ClinicalTrials.gov