Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

February 13, 2024 updated by: Yale University
This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
246

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • The Yale Stress Center: Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Family with a child between 2-5 years
  • BMI of parent ≥30kg/m2
  • Parents aged 18 yrs or older
  • High parent stress (PSS mean score ≥25)
  • Low income family as determined by HHS Poverty Guidelines

Exclusion Criteria:

  • Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
  • Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
  • Inadequate English proficiency to complete questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parenting Mindfully for Health Nutrition (PMH)
Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child.
Behavioral: Parenting Mindfully for Health Nutrition (PMH)

PMH will include included the following components:

  1. mindfulness strategies as outlined in the MBSR manual,
  2. mindful parenting concepts,
  3. mindful eating and awareness of family choices;
  4. self and child monitoring of food intake, PA and emotional reactivity;
  5. utilizing mindfulness for emotion regulation and distress tolerance,
  6. behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA)
Active Comparator: Contact Control Nutrition (C+N)
Contact control intervention (C) + nutrition and physical activity counseling (N).
Behavioral: Contact Control Nutrition (C+N)
Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling.
Other: Historical Control (WLC) non-randomized
Non-randomized, historical control group with only assessments during intervention and follow-up period.
Other: Non-randomized historical control (WLC) assessment only
Non-randomized, historical control group with only assessments during intervention and follow-up period.
Other Names:
  • assessment only group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parent Stress change from Pre to Post intervention
Time Frame: Baseline Pre-intervention to Post intervention at 12 weeks
Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Baseline Pre-intervention to Post intervention at 12 weeks
Child BMI change post intervention and at short term 6 month follow-up
Time Frame: Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up
Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores.
Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up
Child food intake change
Time Frame: Baseline Pre-intervention and at post-intervention (week 12)
Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.
Baseline Pre-intervention and at post-intervention (week 12)
Parenting Behavior Change
Time Frame: TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)
Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT)
TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child food intake change
Time Frame: Baseline Pre-intervention and at post-intervention (week 12)
Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.
Baseline Pre-intervention and at post-intervention (week 12)
Parent Stress change from Post intervention to follow up period over 24-months
Time Frame: Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints
Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints
Child BMI change at long term term follow-up
Time Frame: Baseline compared to 12-month, 18-month and 24-month timepoint
Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores.
Baseline compared to 12-month, 18-month and 24-month timepoint
Parenting Stress Inventory (PSI)
Time Frame: PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints
Parent reported PSI scores ranging from 18-90 with higher scores indicating higher parenting stress.
PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent BMI
Time Frame: baseline
Parent height will be measured with a stadiometer, and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.
baseline
Parent BMI
Time Frame: at 12 week timepoint
Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.
at 12 week timepoint
Parent BMI
Time Frame: at 6 month timepoint
Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.
at 6 month timepoint
Parent BMI
Time Frame: at 12 month timepoint
Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.
at 12 month timepoint
Parent BMI
Time Frame: at 18 month timepoint
Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.
at 18 month timepoint
Parent BMI
Time Frame: at 24 month timepoint
Parent height will be measured with a stadiometer and parent BMI will be calculated from weight and height. For parents, waist circumference (WC) and percent body fat will also be measured using the TANITA and following the well-established NHBLI and NHANES III protocol.
at 24 month timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajita Sinha, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000023271
  • 1R01DK117651-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings