Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05437406

Active, not recruitingNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 12 Years
SexAll
Healthy volunteersNot accepted
ConditionChildhood Obesity, Minority Health

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)Change from baseline to month 3, 6, 12, and 18

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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