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

Kent State University

Status: Completed

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

Treatments: Behavioral: Standard Behavioral Weight Control (SBWC); Behavioral: Mindfulness-Based Weight Control (MBWC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04038684

19-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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139 participants in 2 patient groups

Mindfulness-Based Weight Control

Experimental group

Description:

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).

Treatment:

Behavioral: Mindfulness-Based Weight Control (MBWC)

Standard Behavioral Weight Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Behavioral Weight Control (SBWC)