Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) (FRESH-LC)

May 28, 2026 updated by: Kerri Boutelle, University of California, San Diego

Caregivers as the Agent of Change for Childhood Obesity and Chronic Disease Risk Among Latino Families

The objective of this proposed study is to collect initial efficacy data on a telehealth family-based behavioral program for Latino children with overweight or obesity, which also includes additional caregiver support (PBT-AC), compared with health education (HE).

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

The study will compare the efficacy of PBT-AC and health education program delivered via telehealth on child weight loss. Investigators will provide 6 months of a group program (PBT-AC or HE) and will follow participants at 12-months post-treatment (total time = 18 months). Investigators will recruit children with overweight or obesity and two caregivers. Families will be assessed at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include the following for the child and primary caregiver: anthropometry, blood sample collection, eating behaviors, and family relationship measures. The other caregiver will complete surveys about eating behaviors and family relationships. This program of research has the potential to advance the standard of practice for Latino children with overweight or obesity by developing tailored interventions which can be easily disseminated.

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.
167

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Center for Healthy Eating and Activity Research (CHEAR)

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

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A child with overweight/obesity (85% BMI and above for age) aged 5 to 12 years
  • Primary parent who is responsible for food preparation willing to participate and complete all assessments
  • At least one other caregiver who is over 18 years of age (parent, grandparent, other close family member, friend or child care provider) who is willing to commit to attending at least 50% of all treatment visits
  • Parent and caregiver can read Spanish or English at a minimum of a 5th grade level, and willing to participate in a group setting in Spanish or English together
  • Parent and Child is on a stable medication regimen (minimum of 3 months) for anything that could impact weight.
  • Parent and caregiver have access to a device that can facilitate zoom meetings. If the parent and caregiver do not have access to a device, the family will be provided with such.
  • Family must plan to remain in the San Diego or surrounding areas within the time frame of the study
  • One of the parent or caregivers identifies as Hispanic/Latino

Exclusion Criteria

  • Child diagnosis of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed
  • Child with a severe behavioral or psychiatric disorder that would interfere with treatment (e.g., conduct disorder, severe depression, significant autism spectrum disorder)
  • Acute parent or caregiver psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, bipolar, borderline personality disorder, moderate or severe alcohol or substance use disorder) that could interfere with treatment
  • Inability to participate in physical activity due to significant disability
  • First degree relative or someone in the household with anorexia or bulimia
  • Parent is pregnant or planning on becoming pregnant during the duration of the study
  • Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food post-surgery, or is planning to have a bariatric surgery over the course of study participation (18 months)
  • Parent or child are taking insulin for Type II Diabetes
  • Parent or child are taking weight loss medications

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: PBT-AC
PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth.
Behavioral: Parent-based treatment- All caregivers (PBT-AC)
PBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
Other Names:
  • parent based treatment
  • family based behavioral treatment
Active Comparator: Health Education
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.
Behavioral: Health Education (HE)
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

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
Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)
Time Frame: Change from baseline to month 3, 6, 12, and 18
age and sex adjusted BMI (kg/m^2)
Change from baseline to month 3, 6, 12, and 18

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
Parent body mass index (BMI) as measured by height and weight
Time Frame: Change from baseline to month 3, 6, 12, and 18
BMI (kg/m^2)
Change from baseline to month 3, 6, 12, and 18
Child HgbA1c levels as measured by blood collection
Time Frame: Change from baseline to month 6, 12, and 18
Blood collected via Tasso OnDemand blood kits will be analyzed for HgbA1c levels
Change from baseline to month 6, 12, and 18
Child lipid (e.g., cholesterol) levels as measured by blood collection
Time Frame: Change from baseline to month 6, 12, and 18
Blood collected via Tasso OnDemand blood kits will be analyzed for lipid (e.g., cholesterol) levels
Change from baseline to month 6, 12, and 18
Child dietary intake as measured by 2, 24-hour dietary recalled obtained from the primary parent
Time Frame: Change from baseline to month 6, 12, and 18
Primary caregivers will respond to 2 dietary recall phone calls regarding their child's food intake
Change from baseline to month 6, 12, and 18
Parent dietary intake as measured by the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time Frame: Change from baseline to month 6, 12, and 18
Parents will self-report their own food intake
Change from baseline to month 6, 12, and 18
Child physical activity as measured by parent reported participation in physical and sedentary activity
Time Frame: Change from baseline to month 6, 12, and 18
Parents will report on all of their child's forms of physical activity and time spent being inactive outside of sleep
Change from baseline to month 6, 12, and 18
Parent physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame: Change from baseline to month 6, 12, and 18
Parents will self-report physical activity via the IPAQ, which is a validated physical activity instrument for adults that assesses frequency and duration of various levels of physical activity
Change from baseline to month 6, 12, and 18
Families' home food environment as measured by the Home Food Interview (HFI)
Time Frame: Change from baseline to month 6, 12, and 18
Parents will self-report foods present in the home via the HFI, which is a validated instrument for families
Change from baseline to month 6, 12, and 18
Parenting strategies, confidence, and self-efficacy as measured by the Alabama Parenting Questionnaire (APQ)
Time Frame: Change from baseline to month 6, 12, and 18
Parents will self-report parenting behaviors via the APQ across 5 domains: 1) positive involvement with children, 2) supervision and monitoring, 3) use of positive discipline techniques, 4) consistency in the use of such discipline, and 5) use of corporal punishment. Higher scores indicate greater frequency of engagement with that particular parenting domain. Scores range from 1-5.
Change from baseline to month 6, 12, and 18
Family functioning as measured by the McMaster Family Assessment Device (FAD)
Time Frame: Change from baseline to month 6, 12, and 18
Parents will self-report perceptions on various aspects of family functioning via the FAD, which is a validated family functioning instrument. Raw scores can be calculated for six subscales (Problem Solving, Communication, Roles, Affective Responsiveness, Affective Involvement, and Behavior Control) and for General Functioning. The higher the overall score, the worse the level of family functioning. Scores range from 1-4.
Change from baseline to month 6, 12, and 18
Child eating behavior as measured by the Child Eating Behavioral Questionnaire (CEBQ)
Time Frame: Change from baseline to month 6, 12, and 18
Parents will report on their general child's eating behaviors via the CEBQ, which is a validated eating behaviors instrument for use in children. 8 sub-scales can be calculated, including: food responsiveness, enjoyment of food, emotional overeating, desire to drink, satiety responsiveness, slowness in eating, and emotional undereating, and food fussiness. Higher scores indicate greater frequency of that domain of eating. Scores range from 1-5.
Change from baseline to month 6, 12, and 18
Parent eating behavior as measured by the Adult Eating Behavioral Questionnaire (AEBQ)
Time Frame: Change from baseline to month 6, 12, and 18
Parents will self-report their general eating behaviors via the AEBQ, which is a validated eating behaviors instrument for use in adults. 8 sub-scales can be calculated, including: food responsiveness, enjoyment of food, emotional overeating, hunger, satiety responsiveness, slowness in eating, and emotional undereating, and food fussiness. Higher scores indicate greater frequency of that domain of eating. Scores range from 1-5.
Change from baseline to month 6, 12, and 18

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 California, San Diego

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 on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)
University of Southern California
Children's Hospital Los Angeles

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: Kerri Boutelle, Ph.D., UC San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 8, 2022

Primary Completion (Estimated)

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.
October 1, 2026

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 1, 2026

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).
June 14, 2022

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.
June 24, 2022

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.
June 29, 2022

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.
June 1, 2026

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.
May 28, 2026

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.
May 1, 2026

More Information

Terms related to this study

Keywords

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.
  • 801732
  • 1P50MD017344-01 (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.

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