Wellness and Weight Family Group Project

February 22, 2023 updated by: Crystal Stack Lim, University of Mississippi Medical Center
The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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.
34

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
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

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

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
  2. child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
  3. child or adolescent is accompanied by a parent or legal guardian
  4. participating child and parent speak and read English
  5. family agrees to attend group meetings at a medical clinic over a 3 month period

Exclusion Criteria:

  1. participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
  2. child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
  3. child or parent, according to parent report, in commercial weight loss program
  4. child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
  5. parent and child do not speak and read English

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Behavioral Family Intervention (BFI)
Behavioral: Behavioral Family Intervention (BFI)
Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).

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
Change in Child Weight Status (BMIz)
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
BMIz calculated from measured child height and weight
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

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
Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Child-report questionnaire
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Dietary Intake Total kcals from 24-hour dietary recall
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child A1C Values
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
From child medical chart - testing completed as part of standard medical care
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Glucose Values
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
From child medical chart - testing completed as part of standard medical care
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent Weight
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Measured parent weight
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Parent-report questionnaire
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent Dietary Intake Total kcals from 24-hour dietary recall
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Parent-report 24-hour dietary recall assessed via ASA24-2014
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

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
Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Child-report questionnaire; sum of scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child-Reported Total Health-Related Quality of Life
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Child-report; total score from Pediatric Quality of Life Inventory
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Parent-Reported Total Health-Related Quality of Life
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Parent-report; total score from Pediatric Quality of Life Inventory
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Child Psychological Functioning (Total Problems Subscale from CBCL)
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
parent-report; Child Behavior Checklist (CBCL) Total Problems Scale
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Home Food Inventory Obesiogenic Food Availability Score
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Parent-reported
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Change in Total Parenting Competence
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

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.
University of Mississippi Medical Center

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

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.
February 1, 2016

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.
December 1, 2020

Study Completion (Actual)

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.
December 1, 2022

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).
February 2, 2016

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.
February 4, 2016

First Posted (Estimate)

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.
February 9, 2016

Study Record Updates

Last Update Posted (Estimate)

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 23, 2023

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 22, 2023

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, 2023

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.
  • #2015-0155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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