Childhood ObesityFRESH-LCNCT05437406
Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)
A study testing Parent-based treatment- All caregivers (PBT-AC) and Health Education (HE) in people with Childhood Obesity and Minority Health, run by University of California, San Diego at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Childhood Obesity, Minority Health
- What is being tested?
- Parent-based treatment- All caregivers (PBT-AC) and Health Education (HE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037
About this study
Official title: 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).
Read the 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.
- Conditions
- Childhood Obesity, Minority Health
- Being tested
- Parent-based treatment- All caregivers (PBT-AC), Health Education (HE)
- Keywords
- obesity, treatment, intervention, behavioral treatment, parent based treatment, Hispanic, Latino, children
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-based treatment- All caregivers (PBT-AC)Behavioural
Also called parent based treatment, family based behavioral treatment
PBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
Health Education (HE)Behavioural
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
| Study group | Role | What they receive |
|---|---|---|
| PBT-AC | Experimental | PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth. Receives: Behavioral: Parent-based treatment- All caregivers (PBT-AC) |
| Health Education | Active comparator | This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth. Receives: Behavioral: Health Education (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)
age and sex adjusted BMI (kg/m^2)
Measured: Change from baseline to month 3, 6, 12, and 18
Secondary outcomes (12)
Parent body mass index (BMI) as measured by height and weight
BMI (kg/m^2)
Measured: Change from baseline to month 3, 6, 12, and 18
Child HgbA1c levels as measured by blood collection
Blood collected via Tasso OnDemand blood kits will be analyzed for HgbA1c levels
Measured: Change from baseline to month 6, 12, and 18
Child lipid (e.g., cholesterol) levels as measured by blood collection
Blood collected via Tasso OnDemand blood kits will be analyzed for lipid (e.g., cholesterol) levels
Measured: 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
Primary caregivers will respond to 2 dietary recall phone calls regarding their child's food intake
Measured: 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
Parents will self-report their own food intake
Measured: Change from baseline to month 6, 12, and 18
Child physical activity as measured by parent reported participation in physical and sedentary activity
Parents will report on all of their child's forms of physical activity and time spent being inactive outside of sleep
Measured: Change from baseline to month 6, 12, and 18
Parent physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
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
Measured: Change from baseline to month 6, 12, and 18
Families' home food environment as measured by the Home Food Interview (HFI)
Parents will self-report foods present in the home via the HFI, which is a validated instrument for families
Measured: Change from baseline to month 6, 12, and 18
Parenting strategies, confidence, and self-efficacy as measured by the Alabama Parenting Questionnaire (APQ)
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.
Measured: Change from baseline to month 6, 12, and 18
Family functioning as measured by the McMaster Family Assessment Device (FAD)
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.
Measured: Change from baseline to month 6, 12, and 18
Child eating behavior as measured by the Child Eating Behavioral Questionnaire (CEBQ)
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.
Measured: Change from baseline to month 6, 12, and 18
Parent eating behavior as measured by the Adult Eating Behavioral Questionnaire (AEBQ)
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.
Measured: Change from baseline to month 6, 12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start8 Sep 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Children's Hospital Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437406
- Sponsor's protocol ID
- 801732
- Other IDs
- 1P50MD017344-01
- Acronym
- FRESH-LC
- Status last verified
- May 2026
- First submitted
- 14 Jun 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boutelle KN, Eichen DM, Manzano M, Crespo NC, Rivera-Iniguez I, Castro E, Strong DR, Newell I, Reed K, Marquez B, Rhee KE. Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families. Contemp Clin Trials. 2026 Feb;161:108191. doi: 10.1016/j.cct.2025.108191. Epub 2025 Dec 16.
PubMed 41412474
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregivers as the Agent of Change for Childhood Obesity and Chronic Disease Risk Among Latino Families
- ClinicalTrials.gov ID
- NCT05437406
- Acronym / sponsor ID
- FRESH-LC / 801732
- Conditions
- Childhood Obesity, Minority Health
- Keywords
- obesity, treatment, intervention, behavioral treatment, parent based treatment, Hispanic, Latino, children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Southern California, Children's Hospital Los Angeles, National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBT-AC | Experimental | Behavioral: Parent-based treatment- All caregivers (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. |
| Health Education | Active comparator | Behavioral: Health Education (HE)This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-based treatment- All caregivers (PBT-AC)Also: parent based treatment, family based behavioral treatmentPBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills. | Behavioural | PBT-AC |
| Health Education (HE)The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. | Behavioural | Health Education |
Primary outcome
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)
12 secondary outcomes
Parent body mass index (BMI) as measured by height and weight
Time frame: 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
Child lipid (e.g., cholesterol) levels as measured by blood collection
Time frame: 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
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
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
Parent physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
Time frame: 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
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
Family functioning as measured by the McMaster Family Assessment Device (FAD)
Time frame: 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
Parent eating behavior as measured by the Adult Eating Behavioral Questionnaire (AEBQ)
Time frame: Change from baseline to month 6, 12, and 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 41412474Boutelle KN, Eichen DM, Manzano M, Crespo NC, Rivera-Iniguez I, Castro E, Strong DR, Newell I, Reed K, Marquez B, Rhee KE. Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families. Contemp Clin Trials. 2026 Feb;161:108191. doi: 10.1016/j.cct.2025.108191. Epub 2025 Dec 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Boutelle, Ph.D. principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-based treatment- All caregivers (PBT-AC) and Health Education (HE) in people with Childhood Obesity and Minority Health, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.