NCT03611660

Brief Summary

Participants will be randomized to an evidence-based healthy lifestyle program alone or a healthy lifestyle program with mindfulness meditation added. The purpose of the study will be to determine if mindfulness improves BMI outcomes more than the program alone due to the stress-reduction benefits of mindfulness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 11, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

3.2 years

First QC Date

July 19, 2018

Last Update Submit

June 10, 2021

Conditions

Pediatric Obesity

Keywords

pediatric obesity, stress

Outcome Measures

Primary Outcomes (2)

  • Body Mass Index (BMI)

    Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703

    Change from baseline at 12 weeks

  • Body Mass Index (BMI)

    Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703

    Change from baseline at 9 months

Secondary Outcomes (12)

  • Percent Body Fat

    Change from baseline at 12 weeks

  • Percent Body Fat

    Change from baseline at 9 months

  • Perceived Stress Scale

    Change from baseline at 12 weeks

  • Perceived Stress Scale

    Change from baseline at 9 months

  • Physical Stress

    Change from baseline at 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Traditional Lifestyle Program ONLY

ACTIVE COMPARATOR

Participants will receive an evidence-based 12-week family-based pediatric obesity program.

Behavioral: Traditional Healthy Lifestyle Program

Traditional Lifestyle Program PLUS Mindfulness

EXPERIMENTAL

Participants will receive an evidence-based 12-week family-based pediatric obesity program plus 6 sessions of mindfulness meditation instruction.

Behavioral: Traditional Healthy Lifestyle ProgramBehavioral: Mindfulness Meditation Instruction

Interventions

Traditional Healthy Lifestyle ProgramBEHAVIORAL

Twice weekly meetings that focus on nutrition and exercise for 12 weeks.

Traditional Lifestyle Program ONLYTraditional Lifestyle Program PLUS Mindfulness
Mindfulness Meditation InstructionBEHAVIORAL

Participants receive six mindfulness sessions.

Traditional Lifestyle Program PLUS Mindfulness

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • BMI \>95th percentile for gender \& age
  • English-speaking subject and parent/caregiver
  • Parent/caregiver willing to participate in weight mgt program

You may not qualify if:

  • BMI \>40 \<27
  • Psychiatric disorder or medical condition that precludes participation in program
  • Currently taking medication that causes weight gain or loss
  • Involvement in co-existing weight management program
  • A positive pregnancy test
  • Plans on moving out of the Greater New Haven area within 9 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Center for Clinical Investigation

New Haven, Connecticut, 06520, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 2, 2018

Study Start

January 11, 2018

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

June 11, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)