UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037, United States
NCT Number: NCT05437406
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).
This study is active but is not currently recruiting participants.
Notify Me5 year–12 year
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PBT-AC provides all the elements of FBT, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
Other names: parent based treatment, family based behavioral treatment
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Time frame: Change from baseline to month 3, 6, 12, and 18
age and sex adjusted BMI (kg/m^2)
Time frame: Change from baseline to month 3, 6, 12, and 18
BMI (kg/m^2)
Time frame: Change from baseline to month 6, 12, and 18
Blood collected via Tasso OnDemand blood kits will be analyzed for HgbA1c levels
Time frame: Change from baseline to month 6, 12, and 18
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
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
Parents will self-report their own food intake
Time frame: Change from baseline to month 6, 12, and 18
Parents will report on all of their child's forms of physical activity and time spent being inactive outside of sleep
Time frame: Change from baseline to month 6, 12, and 18
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
Time frame: Change from baseline to month 6, 12, and 18
Parents will self-report foods present in the home via the HFI, which is a validated instrument for families
Time frame: Change from baseline to month 6, 12, and 18
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.
Time frame: Change from baseline to month 6, 12, and 18
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.
Time frame: Change from baseline to month 6, 12, and 18
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.
Time frame: Change from baseline to month 6, 12, and 18
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.
University of California, San Diego
Other
Caregivers as the Agent of Change for Childhood Obesity and Chronic Disease Risk Among Latino Families
Acronym: FRESH-LC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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