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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MD017344-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| Children's Hospital Los Angeles | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBT-AC | Experimental | PBT-AC includes the elements of family based behavioral treatment for obesity, delivered exclusively to caregivers as the agents of change, via telehealth. |
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| Health Education | Active Comparator | This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress via telehealth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child anthropometric change as measured by age and sex adjusted body mass index (BMIz) | age and sex adjusted BMI (kg/m^2) | Change from baseline to month 3, 6, 12, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Parent body mass index (BMI) as measured by height and weight | BMI (kg/m^2) | 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Boutelle, Ph.D. | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Center for Healthy Eating and Activity Research (CHEAR) | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41412474 | Derived | Boutelle KN, Eichen DM, Manzano M, Crespo NC, Rivera-Iniguez I, Castro E, Strong DR, Newell I, Reed K, Marquez B, Rhee KE. Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families. Contemp Clin Trials. 2026 Feb;161:108191. doi: 10.1016/j.cct.2025.108191. Epub 2025 Dec 16. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| National Institutes of Health (NIH) |
| NIH |
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| Health Education (HE) | Behavioral | The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. |
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| 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 | 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 | 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 | 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 | Change from baseline to month 6, 12, and 18 |
| Parent physical activity as measured by the International Physical Activity Questionnaire (IPAQ) | 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 | Change from baseline to month 6, 12, and 18 |
| Families' home food environment as measured by the Home Food Interview (HFI) | Parents will self-report foods present in the home via the HFI, which is a validated instrument for families | Change from baseline to month 6, 12, and 18 |
| Parenting strategies, confidence, and self-efficacy as measured by the Alabama Parenting Questionnaire (APQ) | 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. | Change from baseline to month 6, 12, and 18 |
| Family functioning as measured by the McMaster Family Assessment Device (FAD) | 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. | Change from baseline to month 6, 12, and 18 |
| Child eating behavior as measured by the Child Eating Behavioral Questionnaire (CEBQ) | 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. | Change from baseline to month 6, 12, and 18 |
| Parent eating behavior as measured by the Adult Eating Behavioral Questionnaire (AEBQ) | 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. | Change from baseline to month 6, 12, and 18 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |