Families Becoming Healthy Together
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|ClinicalTrials.gov Identifier: NCT04027426|
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Childhood Obesity||Behavioral: FBT Behavioral: FBT+Variety||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessor will be blinded to randomization. Participants and providers will be blinded to study hypothesis.|
|Official Title:||Families Becoming Healthy Together|
|Estimated Study Start Date :||July 23, 2019|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||March 31, 2024|
Active Comparator: FBT (family-based behavioral treatment)
This condition will be prescribed the Traffic Light Diet (1000-1500 kcal/day, < 2 servings/day of RED [non-nutrient-dense, energy-dense] foods) and a > 60 min/day of MVPA prescription for children and > 30 min/day of MVPA for adults at least 5 days/week. FBT will receive a family-based, behavioral intervention to assist the targeted child and a participating adult caregiver with making changes in energy balance behaviors.
FBT will receive a family-based, behavioral intervention for childhood obesity, consisting of group meetings once a week for months 1 to 4, twice a month for months 5 to 6, once a month for months 7 to 12, and once every two months for months 13 to 18 (29 sessions). For all meetings, the child and adult caregiver will be weighed and be provided with feedback, homework will be reviewed, and a behavioral lesson will be presented. At the 60-min meetings, the child and adult will attend separate 40 min group meetings, and then for the last 20 min of the meetings they will meet together with an individual therapist to address specific family-issues by developing behavioral action plans. No goals on variety in RED foods will be provided.
The FBT+Variety condition will receive FBT along with a limited variety prescription. In this prescription families will identify two RED foods, a dinner entree and snack food, and develop meal plans that reduce variety of RED foods by regularly consuming these foods and limiting consumption of other RED entrees and snack foods.
This condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed.
- Child and adult body mass index [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Child's and adult caregiver's weight will be assessed by an electronic scale and height will be measured by a stadiometer.
- Child and adult salivary habituation [ Time Frame: Change from 0 to 6, and 6 to 18 months ]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.
- Child and adult dietary Intake [ Time Frame: Change from 0 to 6, and 6 to 18 months ]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.
- Child and adult physical activity via wGT3X-BT [ Time Frame: Change from 0 to 6, and 6 to 18 months ]The wGT9x (ActiGraph, LLC, Pensacola, FL) will objectively measure time spent in MVPA (physical activity at > 3.0 metabolic equivalents units).
- Child percent overweight [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Percent overweight (%OW) will also be calculated (100*[BMI/50th percentile BMI for child age and sex]).
- Child and adult waist circumference [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Waist circumference (WC) will be measured using standard procedures.
- Meal planning, preparation, and grocery shopping [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Parent time scarcity and fatigue as barriers to planning and preparing meals will measure frequency of occurrence of these barriers.
- Child eating pathology [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Child eating pathology will be assessed using the Kid's Eating Disorder Survey
- Home Food Inventory [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Self-reported inventory of foods available in the household will be assessed
- Child and Adult Sleep Habits [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Usual sleeping and waking time will be collected
- Child Routines [ Time Frame: Change from 0 to 6, and 6 to 18 months ]Parent-report measure of commonly occurring routines in school-aged children will measure the frequency of occurrence of routines in children.
- Compliance and process data [ Time Frame: 6, 12, and 18 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027426
|Contact: Hollie Raynor, PhD RD LDNemail@example.com|
|United States, Tennessee|
|Healthy Eating and Activity Lab, University of Tennessee||Recruiting|
|Knoxville, Tennessee, United States, 37996|
|Contact: Hollie A Raynor, PhD RD LDN 865-974-6259 firstname.lastname@example.org|
|Principal Investigator:||Hollie Raynor, PhD RD LDN||University of Tennessee Knoxville|