Families Becoming Healthy Together

NCT04027426 | Completed

• 2 other identifiers: UTK IRB-18-04910-XP1R01DK121360
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Childhood Obesity

Keywords

Habituation

Outcome Measures

Primary Outcomes (2)

• Child and adult body mass index

  Child's and adult caregiver's weight will be assessed by an electronic scale and height will be measured by a stadiometer.

  Change from 0 to 6, and 6 to 18 months

• Child and adult salivary habituation

  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.

  Change from 0 to 6, and 6 to 18 months

Secondary Outcomes (10)

• Child and adult dietary Intake

  Change from 0 to 6, and 6 to 18 months

• Child and adult physical activity via wGT3X-BT

  Change from 0 to 6, and 6 to 18 months

• Child percent overweight

  Change from 0 to 6, and 6 to 18 months

• Child and adult waist circumference

  Change from 0 to 6, and 6 to 18 months

• Meal planning, preparation, and grocery shopping

  Change from 0 to 6, and 6 to 18 months

Study Arms (2)

FBT (family-based behavioral treatment)

ACTIVE COMPARATOR

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+Variety

EXPERIMENTAL

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

Interventions

FBT BEHAVIORAL

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.

FBT (family-based behavioral treatment)

FBT+Variety BEHAVIORAL

This condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed.

FBT+Variety

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 report having bariatric surgery for weight loss/planning to have bariatric surgery in the next 18 months, adult caregiver having bariatric surgery in the previous two years or 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 (defined as from Nashville to the east state border of Tennessee) or Memphis (this may include residents who live in Arkansas or Mississippt) 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.
• do not have reliable internet access.
• participation in the study creates conflict with child's educational support or health condition treatment/program due to time needs, incompatible goals, or strain on family resources.

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• The Miriam Hospital: collaborator
• University of Memphis: collaborator
• University at Buffalo: collaborator

Study Sites (1)

Healthy Eating and Activity Lab, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (12)

• Altman M, Wilfley DE. Evidence update on the treatment of overweight and obesity in children and adolescents. J Clin Child Adolesc Psychol. 2015;44(4):521-37. doi: 10.1080/15374416.2014.963854. Epub 2014 Dec 12.

  PMID: 25496471 BACKGROUND

• Epstein LH, Temple JL, Roemmich JN, Bouton ME. Habituation as a determinant of human food intake. Psychol Rev. 2009 Apr;116(2):384-407. doi: 10.1037/a0015074.

  PMID: 19348547 BACKGROUND

• Epstein LH, Robinson JL, Temple JL, Roemmich JN, Marusewski AL, Nadbrzuch RL. Variety influences habituation of motivated behavior for food and energy intake in children. Am J Clin Nutr. 2009 Mar;89(3):746-54. doi: 10.3945/ajcn.2008.26911. Epub 2009 Jan 28.

  PMID: 19176724 BACKGROUND

• Temple JL, Giacomelli AM, Roemmich JN, Epstein LH. Dietary variety impairs habituation in children. Health Psychol. 2008 Jan;27(1S):S10-9. doi: 10.1037/0278-6133.27.1.S10.

  PMID: 18248101 BACKGROUND

• Epstein LH, Fletcher KD, O'Neill J, Roemmich JN, Raynor H, Bouton ME. Food characteristics, long-term habituation and energy intake. Laboratory and field studies. Appetite. 2013 Jan;60(1):40-50. doi: 10.1016/j.appet.2012.08.030. Epub 2012 Oct 22.

  PMID: 23085682 BACKGROUND

• Epstein LH, Robinson JL, Temple JL, Roemmich JN, Marusewski A, Nadbrzuch R. Sensitization and habituation of motivated behavior in overweight and non-overweight children. Learn Motiv. 2008 Aug;39(3):243-255. doi: 10.1016/j.lmot.2008.03.001.

  PMID: 19649135 BACKGROUND

• Bond DS, Raynor HA, McCaffery JM, Wing RR. Salivary habituation to food stimuli in successful weight loss maintainers, obese and normal-weight adults. Int J Obes (Lond). 2010 Mar;34(3):593-6. doi: 10.1038/ijo.2009.267. Epub 2009 Dec 15.

  PMID: 20010900 BACKGROUND

• Bond DS, Raynor HA, Vithiananthan S, Sax HC, Pohl D, Roye GD, Ryder BA, Wing RR. Differences in salivary habituation to a taste stimulus in bariatric surgery candidates and normal-weight controls. Obes Surg. 2009 Jul;19(7):873-8. doi: 10.1007/s11695-009-9861-3. Epub 2009 May 20.

  PMID: 19455371 BACKGROUND

• Epstein LH, Carr KA, Cavanaugh MD, Paluch RA, Bouton ME. Long-term habituation to food in obese and nonobese women. Am J Clin Nutr. 2011 Aug;94(2):371-6. doi: 10.3945/ajcn.110.009035. Epub 2011 May 18.

  PMID: 21593492 BACKGROUND

• Temple JL, Giacomelli AM, Roemmich JN, Epstein LH. Overweight children habituate slower than non-overweight children to food. Physiol Behav. 2007 Jun 8;91(2-3):250-4. doi: 10.1016/j.physbeh.2007.03.009. Epub 2007 Mar 16.

  PMID: 17459429 BACKGROUND

• Aspen VA, Stein RI, Wilfley DE. An exploration of salivation patterns in normal weight and obese children. Appetite. 2012 Apr;58(2):539-42. doi: 10.1016/j.appet.2011.11.027. Epub 2011 Dec 3.

  PMID: 22172456 BACKGROUND

• Epstein LH, Kilanowski C, Paluch RA, Raynor H, Daniel TO. Reducing variety enhances effectiveness of family-based treatment for pediatric obesity. Eat Behav. 2015 Apr;17:140-3. doi: 10.1016/j.eatbeh.2015.02.001. Epub 2015 Feb 13.

  PMID: 25706950 BACKGROUND

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Hollie Raynor, PhD RD LDN

  University of Tennessee Knoxville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blinded to randomization. Participants and providers will be blinded to study hypothesis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 22, 2019
• Study Start: October 29, 2019
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)