NCT03085160

Brief Summary

Research suggests there is a connection between mood and weight. People who feel stressed or depressed are more likely to be overweight than people who don't have these feelings. Some individuals turn to food to cope, which can lead to gaining too much weight over time. Adolescence is an important time to understand these connections. Patterns of handling stress learned during adolescence set the stage for stress management in adulthood. This study is a randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic obesity. The investigators will test if taking part in a 6-week group program to lower stress and improve mood will be helpful to teens at-risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

6.1 years

First QC Date

March 9, 2017

Last Update Submit

February 3, 2021

Conditions

ObesityAdolescent DevelopmentStress

Outcome Measures

Primary Outcomes (3)

  • Feasibility of study

    Rate of recruitment of eligible adolescent volunteers

    3 years

  • Acceptability of program

    Session attendance determined as percentage of total sessions (6) attended

    6 weeks

  • Acceptability of study participation

    Post-intervention acceptability ratings

    6 weeks

Secondary Outcomes (6)

  • Perceived stress

    6 months

  • Executive function

    6 months

  • Food reward sensitivity

    6 months

  • Meal intake

    6 months

  • Weight gain

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Learning to Breathe

EXPERIMENTAL

Six-week mindfulness-based group program for adolescents

Behavioral: Learning to Breathe

Health Education

ACTIVE COMPARATOR

Six-week health education group program for adolescents

Behavioral: Health Education

Interventions

Learning to BreatheBEHAVIORAL

Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress

Learning to Breathe
Health EducationBEHAVIORAL

Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others

Health Education

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 12-17 years
  • At-risk for long-term obesity by virtue of current BMI (≥70th percentile for age and sex) or obesity (BMI ≥30 kg/m2) in both biological parents
  • Good general health

You may not qualify if:

  • Current full-syndrome psychiatric disorder that in the investigators' opinion would impede study compliance
  • Major medical problem such as type 2 diabetes
  • Use of medication affecting mood or body weight such as stimulants or anti-depressants
  • Any medical issues that could be acutely worsened by exercise such as asthma or musculoskeletal problems.
  • Pregnancy in females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Related Publications (1)

  • Shomaker LB, Berman Z, Burke M, Annameier SK, Pivarunas B, Sanchez N, Smith AD, Hendrich S, Riggs NR, Legget KT, Cornier MA, Melby C, Johnson SA, Lucas-Thompson R. Mindfulness-based group intervention in adolescents at-risk for excess weight gain: A randomized controlled pilot study. Appetite. 2019 Sep 1;140:213-222. doi: 10.1016/j.appet.2019.05.022. Epub 2019 May 18.

    PMID: 31112737DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 21, 2017

Study Start

October 27, 2014

Primary Completion

December 5, 2020

Study Completion

December 5, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)