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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

167 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-08

Study Completion Date

2026-10-31

Brief Summary

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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).

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Detailed Description

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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

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Childhood Obesity Minority Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Health Education

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

Group Type ACTIVE_COMPARATOR

Health Education (HE)

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Health Education (HE)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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parent based treatment family based behavioral treatment

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No