Clinical trial NCT04038684: Healthy Eating, Activity and Reduction of Teen Stress
Official title: Healthy Eating, Activity and Reduction of Teen Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Overweight Adolescents
Emotional Stress
Stress, Psychological
Eating Behavior
Keywords: Emotional Eating
Low-income
Mindfulness
Adolescent
Obesity
Weight Management
Stress
Pediatric
Lead sponsor: Kent State University
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: The Miriam Hospital
name: Brown University
name: Rhode Island Hospital
name: University of North Carolina, Chapel Hill
name: University of Michigan
First posted: 2019-07-31
Enrollment: 139
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Adolescent Body Mass Index (BMI)
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Emotional Eating
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Perceived Stress
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Stress
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Chronic Stress
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Intervention Acceptability and Feasibility
timeFrame: End of treatment (approx 14 weeks after baseline)
Secondary outcomes:
measure: Change in Adolescent Eating Pathology and Symptomology
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Eating Behaviors
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Emotion Regulation
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Mindfulness
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Mindful Attention Awareness
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Quality of Life - Adolescent Report
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
measure: Change in Adolescent Quality of Life - Parent/Caregiver Report
timeFrame: baseline to intervention completion (approx 14 weeks), baseline to 3-month follow-up (approx 26 weeks), and intervention completion to 3-month follow-up.
Other outcomes:
Locations:
city: Kent
country: United States
facility: Kent State University
state: Ohio
Study officials:
affiliation: Kent State University
name: Amy F Sato, PhD
role: PRINCIPAL_INVESTIGATOR
References: