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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
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Miriam Hospital
University of Memphis
University at Buffalo
Information provided by (Responsible Party):
Hollie Raynor, The University of Tennessee, Knoxville

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Childhood Obesity Behavioral: FBT Behavioral: FBT+Variety Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Behavioral: FBT
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.

Experimental: FBT+Variety
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.
Behavioral: FBT+Variety
This condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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]).

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age between 8 and 12 years
  • > 85th percentile BMI
  • one adult caregiver (> 18 years) living in the household with a BMI > 25 kg/m2 willing to attend treatment meetings

Exclusion Criteria:

  • child and adult caregiver report living in two separate households for > 2 days per week
  • child or adult caregiver report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (individuals reporting joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate)
  • child or adult caregiver report being unable to walk for 2 blocks (1/4 mile) without stopping
  • child or adult caregiver report major psychiatric diseases or organic brain syndromes
  • child or adult caregiver report currently participating in a weight loss program and/or taking weight loss or appetite regulation medication or lost > 5% of body weight during the past 6 months
  • child or adult caregiver report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 18 months
  • adult caregiver reports being pregnant, lactating, less than 6 months post-partum or plans to become pregnant in the next 18 months
  • child or adult caregiver report planning to move outside of the metropolitan area within the time frame of the investigation
  • child or adult caregiver report dietary restrictions for medical reasons
  • child or adult caregiver report allergies to lemon or lime juice (used in habituation measures)
  • child is not able to read at a third-grade reading level.

Information from the National Library of Medicine

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


Contacts
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Contact: Hollie Raynor, PhD RD LDN 865-974-6259 hraynor@utk.edu

Locations
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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    hraynor@utk.edu   
Sponsors and Collaborators
The University of Tennessee, Knoxville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Miriam Hospital
University of Memphis
University at Buffalo
Investigators
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Principal Investigator: Hollie Raynor, PhD RD LDN University of Tennessee Knoxville
  Study Documents (Full-Text)

Documents provided by Hollie Raynor, The University of Tennessee, Knoxville:
Informed Consent Form  [PDF] July 3, 2019


Publications:

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Responsible Party: Hollie Raynor, Interim Assistant Dean of Research, The University of Tennessee, Knoxville
ClinicalTrials.gov Identifier: NCT04027426     History of Changes
Other Study ID Numbers: UTK IRB-18-04910-XP
1R01DK121360 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hollie Raynor, The University of Tennessee, Knoxville:
Habituation
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms