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

Primary Purpose

Childhood Obesity, Minority Health

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Parent-based treatment- All caregivers (PBT-AC)

Health Education (HE)

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring obesity, treatment, intervention, behavioral treatment, parent based treatment, Hispanic, Latino, children

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A child with overweight/obesity (85-99.9 percentile BMI for age and sex) aged 5 to 10 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

Sites / Locations

UC San Diego Center for Healthy Eating and Activity Research (CHEAR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PBT-AC

Health Education

Arm Description

PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth.

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.

Outcomes

Primary Outcome Measures

Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)

age and sex adjusted BMI (kg/m^2)

Secondary Outcome Measures

Parent body mass index (BMI) as measured by height and weight

BMI (kg/m^2)

Child HgbA1c levels as measured by blood collection

Blood collected via Tasso OnDemand blood kits will be analyzed for HgbA1c levels

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

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

Parent dietary intake as measured by the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool

Parents will self-report their own food intake

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

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

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

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.

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.

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.

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.

Full Information

NCT ID

NCT05437406

First Posted

June 14, 2022

Last Updated

March 30, 2023

Sponsor

University of California, San Diego

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05437406

Brief Title

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

Acronym

FRESH-LC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 8, 2022 (Actual)

Primary Completion Date

April 2026 (Anticipated)

Study Completion Date

April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Childhood Obesity, Minority Health

Keywords

obesity, treatment, intervention, behavioral treatment, parent based treatment, Hispanic, Latino, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PBT-AC

Arm Type

Experimental

Arm Description

PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth.

Arm Title

Health Education

Arm Type

Active Comparator

Arm Description

This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth.

Intervention Type

Behavioral

Intervention Name(s)

Parent-based treatment- All caregivers (PBT-AC)

Other Intervention Name(s)

parent based treatment, family based behavioral treatment

Intervention Description

PBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills.

Intervention Type

Behavioral

Intervention Name(s)

Health Education (HE)

Intervention Description

The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.

Primary Outcome Measure Information:

Title

Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)

Description

age and sex adjusted BMI (kg/m^2)

Time Frame

Change from baseline to month 3, 6, 12, and 18

Secondary Outcome Measure Information:

Title

Parent body mass index (BMI) as measured by height and weight

Description

BMI (kg/m^2)

Time Frame

Change from baseline to month 3, 6, 12, and 18

Title

Child HgbA1c levels as measured by blood collection

Description

Blood collected via Tasso OnDemand blood kits will be analyzed for HgbA1c levels

Time Frame