Clinical trial NCT05437406: Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC)
Official title: Caregivers as the Agent of Change for Childhood Obesity and Chronic Disease Risk Among Latino Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Childhood Obesity
Minority Health
Keywords: obesity
treatment
intervention
behavioral treatment
parent based treatment
Hispanic
Latino
children
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Children's Hospital Los Angeles
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institutes of Health (NIH)
First posted: 2022-06-29
Enrollment: 167
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Child anthropometric change as measured by age and sex adjusted body mass index (BMIz)
timeFrame: Change from baseline to month 3, 6, 12, and 18
Secondary outcomes:
measure: Parent body mass index (BMI) as measured by height and weight
timeFrame: Change from baseline to month 3, 6, 12, and 18
measure: Child HgbA1c levels as measured by blood collection
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child lipid (e.g., cholesterol) levels as measured by blood collection
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child dietary intake as measured by 2, 24-hour dietary recalled obtained from the primary parent
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parent dietary intake as measured by the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child physical activity as measured by parent reported participation in physical and sedentary activity
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parent physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
timeFrame: Change from baseline to month 6, 12, and 18
measure: Families' home food environment as measured by the Home Food Interview (HFI)
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parenting strategies, confidence, and self-efficacy as measured by the Alabama Parenting Questionnaire (APQ)
timeFrame: Change from baseline to month 6, 12, and 18
measure: Family functioning as measured by the McMaster Family Assessment Device (FAD)
timeFrame: Change from baseline to month 6, 12, and 18
measure: Child eating behavior as measured by the Child Eating Behavioral Questionnaire (CEBQ)
timeFrame: Change from baseline to month 6, 12, and 18
measure: Parent eating behavior as measured by the Adult Eating Behavioral Questionnaire (AEBQ)
timeFrame: Change from baseline to month 6, 12, and 18
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
state: California
Study officials:
affiliation: UC San Diego
name: Kerri Boutelle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: