There is one clinical trial.
The investigators plan to implement a novel limited RED (high-energy-dense) food variety prescription within a 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first randomized control trial to examine how habituation rate, assessed via salivary habituation, mediates reduction in RED food intake, overall energy intake, and reductions in BMI over time, as well as if baseline habituation rate is a behavioral phenotype that moderates BMI outcomes. One hundred fifty-six children aged 8 to 12 years at > 85th percentile BMI will be randomized to one of two, 18-month interventions compared in our 6-month pilot study: FBT (family-based behavioral obesity treatment) or FBT+Variety. Child and adult caregiver assessments will occur at 0, 6, 12, and 18 months on anthropometrics, dietary intake (RED food variety, energy, and diet quality), habituation, and physical activity.
Description: Child's and adult caregiver's weight will be assessed by an electronic scale and height will be measured by a stadiometer.
Measure: Child and adult body mass index Time: Change from 0 to 6, and 6 to 18 monthsDescription: To assess habituation of salivary responses to food cues, whole mouth parotid salivary flow will be measured using the Strongin-Hinsie Peck method. Two measures will be taken, one with juice and one with food.
Measure: Child and adult salivary habituation Time: Change from 0 to 6, and 6 to 18 monthsDescription: Dietary intake for both the child and adult caregiver will be assessed by 3 (2 weekdays and 1 weekend day) 24-hour dietary phone recalls, using the five-step, multiple-pass method. Variables of interest will be the variety of RED foods consumed over the three days; and the mean over the three days of daily servings and kcal from RED foods, kcal, energy density (kcal/g), and Healthy Eating Index (HEI)-2015. Adherence to the prescriptions in the two conditions will be examined. At 6, 12, and 18 months, the percentage of goals met each day will be calculated, with a mean percentage calculated. We will also provide a detailed list of snack foods to participants, and they will be asked to indicate which of the foods on the list were eaten during the previous month, regardless of quantity consumed.
Measure: Child and adult dietary Intake Time: Change from 0 to 6, and 6 to 18 monthsDescription: The wGT9x (ActiGraph, LLC, Pensacola, FL) will objectively measure time spent in MVPA (physical activity at > 3.0 metabolic equivalents units).
Measure: Child and adult physical activity via wGT3X-BT Time: Change from 0 to 6, and 6 to 18 monthsDescription: Percent overweight (%OW) will also be calculated (100*[BMI/50th percentile BMI for child age and sex]).
Measure: Child percent overweight Time: Change from 0 to 6, and 6 to 18 monthsDescription: Waist circumference (WC) will be measured using standard procedures.
Measure: Child and adult waist circumference Time: Change from 0 to 6, and 6 to 18 monthsDescription: Parent time scarcity and fatigue as barriers to planning and preparing meals will measure frequency of occurrence of these barriers.
Measure: Meal planning, preparation, and grocery shopping Time: Change from 0 to 6, and 6 to 18 monthsDescription: Child eating pathology will be assessed using the Kid's Eating Disorder Survey
Measure: Child eating pathology Time: Change from 0 to 6, and 6 to 18 monthsDescription: Self-reported inventory of foods available in the household will be assessed
Measure: Home Food Inventory Time: Change from 0 to 6, and 6 to 18 monthsDescription: Usual sleeping and waking time will be collected
Measure: Child and Adult Sleep Habits Time: Change from 0 to 6, and 6 to 18 monthsDescription: Parent-report measure of commonly occurring routines in school-aged children will measure the frequency of occurrence of routines in children.
Measure: Child Routines Time: Change from 0 to 6, and 6 to 18 monthsDescription: Total number of weekly, and type, of self-monitoring records (hard copy or electronic) completed will be assessed. Number of treatment sessions attended will be recorded.
Measure: Compliance and process data Time: 6, 12, and 18 months