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

N/AActive Not RecruitingNCT05437406

University of California, San Diego167 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

167

Conditions

Childhood Obesity Minority Health

Interventions

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

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

Health Education (HE)BEHAVIORAL

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

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

La Jolla, California, United States

Outcomes

Primary Outcomes

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

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

Time frame: Change from baseline to month 3, 6, 12, and 18

Secondary Outcomes

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

BMI (kg/m\^2)

Time frame: 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

Time frame: 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

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

Primary caregivers will respond to 2 dietary recall phone calls regarding their child's food intake

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

Parents will self-report their own food intake

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

Parents will report on all of their child's forms of physical activity and time spent being inactive outside of sleep

Data from ClinicalTrials.gov

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