ObesityNCT04027426
Families Becoming Healthy Together
A study testing FBT and FBT+Variety in people with Obesity and Childhood Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood Obesity
- What is being tested?
- FBT and FBT+Variety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Lab, University of Tennessee
Knoxville, Tennessee, 37996
About this study
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.
Read the detailed description
Identifying successful methods for reducing long-term energy intake continues to be a challenge in obesity treatment. Basic behavioral research has found that the rate of habituation (i.e., rate of reduction in physiological and behavioral responding) to food is related to amount of food consumed, and faster habituation rates reduce food intake. The rate of habituation to food can be accelerated when variety in foods is limited, producing decreased intake. Thus, a dietary prescription that limits variety of high-energy-dense (HED) foods may boost ability to reduce long-term energy intake, enhancing long-term weight loss.
Furthermore, habituation rates to food show large individual variability. For example, individuals with overweight habituate slower to food than individuals with a healthy weight, and slower habituation rates predict greater increases in child standardized body mass index (ZBMI). Thus, slower habituation rates to food may be a behavioral phenotype for increased risk of suboptimal weight outcomes. Obesity interventions that accelerate habituation to food may then be more beneficial for those with this behavioral phenotype.
The investigators have been conducting a line of translational research that applies habituation theory to obesity treatment involving: 1) studies systematically testing basic concepts to better inform intervention development; 2) "proof-of-concept" testing; and 3) efficacy trials. The long-term goal of this research is to develop a dietary prescription that harnesses habituation as a mechanism for reducing long-term energy intake. This research has culminated in piloting a limited variety prescription (variety of both HED snack foods and entrees at dinner were limited) within a 6-month family-based behavioral obesity treatment (FBT) for children. Twenty-four families, with a child > 85th percentile BMI and aged 8 to 12 years, were randomized to FBT that included the Traffic Light Diet (1000-1500 kcal/day, < 2 servings/day of RED [HED] foods) and a > 60 min/day of moderate- to vigorous-intensity physical activity prescription or to FBT that included a limited dietary variety prescription (one RED snack food and dinner entrée were chosen; families regularly consumed these foods as compared to other RED snack foods and entrees) (FBT+Variety). At 6-months children in FBT+Variety had a significantly greater reduction in percent overweight than those in FBT (-15.4% vs.- 8.9%), and families in FBT+Variety had a lower daily intake of kcal from fat (351 kcal vs. 494 kcal). This limited dietary variety prescription shows promise for enhancing weight outcomes in FBT. However, research is needed to examine if limiting variety improves long-term weight loss, if this improvement is due to enhanced habituation, and explore if there is a behavioral phenotype that more greatly benefits from this dietary approach.
The investigators plan to implement a novel limited RED food variety prescription within an 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first RCT 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 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. The investigation was designed for all intervention sessions and assessments to be conducted in person. Due to COVID-19, modifications have occurred to the trial for health safety reasons. Initially, all meetings and assessments were to occur in-person. Due to the constant changing health safety requirements due to COVID-19, the trial puts in place health safety practices to maintain the safety of participants. Assessment meetings and program meetings will occur remotely via Zoom.
The primary aims are to determine for children:
- Influence of FBT+Variety on long-term weight loss.
- Influence of FBT+Variety on long-term habituation to RED foods. The habituation rate will mediate differences in dietary intake and BMI between conditions.
An exploratory aim is to examine in children:
- Influence of habituation rate on moderating outcomes in FBT+Variety and FBT (identifying a behavioral phenotype that bests benefits from a limited variety prescription).
Comparisons will also be made between the conditions on all child dietary and activity measures. Additionally, adult caregiver measures will be examined, with outcomes anticipated to be similar to child outcomes.
- Conditions
- Obesity, Childhood Obesity
- Being tested
- FBT, FBT+Variety
- Keywords
- Habituation
- Medical subject headings
- Obesity, Pediatric Obesity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBTBehavioural
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+VarietyBehavioural
This condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: FBT+Variety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Body Mass Index
Child's weight will be assessed by an electronic scale and height will be measured by a stadiometer.
Measured: Change from 0 to 6, and 6 to 18 months.
Child 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. This measure is for salivary response to RED (high-energy-dense, non-nutrient dense food) foods. The measure is change in grams of salivation from the mean of the first two food presentations trials to the last two food presentations, with 10 RED food presentations occurring in total.
Measured: Change from 0 to 6, and 6 to 18 months
Secondary outcomes (9)
Child Body Mass Index Z-score
Child's weight will be assessed by an electronic scale and height will be measured by a stadiometer.
Measured: Change from 0 to 6 and 6 to 18 months
Child Percent Overweight
Percent overweight (%OW) will also be calculated (100*[BMI/50th percentile BMI for child age and sex]).
Measured: Change from 0 to 6, and 6 to 18 months
Child Waist Circumference
Waist circumference (WC) will be measured using standard procedures.
Measured: Change from 0 to 6, and 6 to 18 months
Child Dietary Intake - Variety of RED Foods Consumed
Dietary intake 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.
Measured: Change from 0 to 6, and 6 to 18 months
Child Dietary Intake - Daily Servings of RED Foods
Dietary intake 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 mean over the three days of daily servings from RED foods.
Measured: Change from 0 to 6 and 6 to 18 months
Child Dietary Intake - Daily kcal From RED Foods
Dietary intake 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 mean over the three days of daily kcal from RED foods.
Measured: Change from 0 to 6 and 6 to 18 months
Child Dietary Intake - Daily Energy
Dietary intake 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 is the mean over the three days of daily kcal.
Measured: Change from 0 to 6 and 6 to 18 months
Child Dietary Intake - Daily HEI
Dietary intake 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 mean over the three days of daily Healthy Eating Index (HEI)-2015. Minimum value is 0 and Maximum value is 100, with higher scores indicating a diet higher in quality and more closely following dietary guidelines.
Measured: Chage from 0 to 6 and 6 to 18 months
Child Physical Activity
The wGT9x (ActiGraph, LLC, Pensacola, FL) will objectively measure activity, quantified as metabolic equivalent (MET) values. Higher MET values indicate higher intensity physical activity, and a mean for a day reports on the average level of physical activity in the day. A higher mean daily MET value indicates greater physical activity.
Measured: Change from 0 to 6, and 6 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start29 Oct 2019
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Miriam Hospital, University of Memphis, University at Buffalo
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
- Investigators
- Hollie Raynor, PhD RD LDN, Principal investigator, University of Tennessee Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027426
- Sponsor's protocol ID
- UTK IRB-18-04910-XP
- Other IDs
- 1R01DK121360
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2019
- Last updated
- 19 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25496471Epstein 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.
PubMed 19348547Epstein 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.
PubMed 19176724Temple 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.
PubMed 18248101Epstein 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.
PubMed 23085682Epstein 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.
PubMed 19649135Bond 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.
PubMed 20010900Bond 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.
PubMed 19455371Epstein 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.
PubMed 21593492Temple 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.
PubMed 17459429Aspen 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.
PubMed 22172456Epstein 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.
PubMed 25706950
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Becoming Healthy Together
- ClinicalTrials.gov ID
- NCT04027426
- Acronym / sponsor ID
- UTK IRB-18-04910-XP
- Conditions
- Obesity, Childhood Obesity
- Keywords
- Habituation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Miriam Hospital, University of Memphis, University at Buffalo
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 22 Jul 2019 (actual)
- Results
- Posted 19 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Identifying successful methods for reducing long-term energy intake continues to be a challenge in obesity treatment. Basic behavioral research has found that the rate of habituation (i.e., rate of reduction in physiological and behavioral responding) to food is related to amount of food consumed, and faster habituation rates reduce food intake. The rate of habituation to food can be accelerated when variety in foods is limited, producing decreased intake. Thus, a dietary prescription that limits variety of high-energy-dense (HED) foods may boost ability to reduce long-term energy intake, enhancing long-term weight loss.
Furthermore, habituation rates to food show large individual variability. For example, individuals with overweight habituate slower to food than individuals with a healthy weight, and slower habituation rates predict greater increases in child standardized body mass index (ZBMI). Thus, slower habituation rates to food may be a behavioral phenotype for increased risk of suboptimal weight outcomes. Obesity interventions that accelerate habituation to food may then be more beneficial for those with this behavioral phenotype.
The investigators have been conducting a line of translational research that applies habituation theory to obesity treatment involving: 1) studies systematically testing basic concepts to better inform intervention development; 2) "proof-of-concept" testing; and 3) efficacy trials. The long-term goal of this research is to develop a dietary prescription that harnesses habituation as a mechanism for reducing long-term energy intake. This research has culminated in piloting a limited variety prescription (variety of both HED snack foods and entrees at dinner were limited) within a 6-month family-based behavioral obesity treatment (FBT) for children. Twenty-four families, with a child > 85th percentile BMI and aged 8 to 12 years, were randomized to FBT that included the Traffic Light Diet (1000-1500 kcal/day, < 2 servings/day of RED [HED] foods) and a > 60 min/day of moderate- to vigorous-intensity physical activity prescription or to FBT that included a limited dietary variety prescription (one RED snack food and dinner entrée were chosen; families regularly consumed these foods as compared to other RED snack foods and entrees) (FBT+Variety). At 6-months children in FBT+Variety had a significantly greater reduction in percent overweight than those in FBT (-15.4% vs.- 8.9%), and families in FBT+Variety had a lower daily intake of kcal from fat (351 kcal vs. 494 kcal). This limited dietary variety prescription shows promise for enhancing weight outcomes in FBT. However, research is needed to examine if limiting variety improves long-term weight loss, if this improvement is due to enhanced habituation, and explore if there is a behavioral phenotype that more greatly benefits from this dietary approach.
The investigators plan to implement a novel limited RED food variety prescription within an 18-month FBT to examine its effect on 18-month body mass index (BMI). This will be the first RCT 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 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. The investigation was designed for all intervention sessions and assessments to be conducted in person. Due to COVID-19, modifications have occurred to the trial for health safety reasons. Initially, all meetings and assessments were to occur in-person. Due to the constant changing health safety requirements due to COVID-19, the trial puts in place health safety practices to maintain the safety of participants. Assessment meetings and program meetings will occur remotely via Zoom.
The primary aims are to determine for children:
- Influence of FBT+Variety on long-term weight loss.
- Influence of FBT+Variety on long-term habituation to RED foods. The habituation rate will mediate differences in dietary intake and BMI between conditions.
An exploratory aim is to examine in children:
- Influence of habituation rate on moderating outcomes in FBT+Variety and FBT (identifying a behavioral phenotype that bests benefits from a limited variety prescription).
Comparisons will also be made between the conditions on all child dietary and activity measures. Additionally, adult caregiver measures will be examined, with outcomes anticipated to be similar to child outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FBT (family-based behavioral treatment) | Active comparator | Behavioral: FBTThis 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+Variety | Experimental | Behavioral: FBT+VarietyThe 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FBTFBT 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. | Behavioural | FBT (family-based behavioral treatment) |
| FBT+VarietyThis condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed. | Behavioural | FBT+Variety |
Primary outcome
Child Body Mass Index
Time frame: Change from 0 to 6, and 6 to 18 months.
Child's weight will be assessed by an electronic scale and height will be measured by a stadiometer.
Child 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. This measure is for salivary response to RED (high-energy-dense, non-nutrient dense food) foods. The measure is change in grams of salivation from the mean of the first two food presentations trials to the last two food presentations, with 10 RED food presentations occurring in total.
9 secondary outcomes
Child Body Mass Index Z-score
Time frame: Change from 0 to 6 and 6 to 18 months
Child Percent Overweight
Time frame: Change from 0 to 6, and 6 to 18 months
Child Waist Circumference
Time frame: Change from 0 to 6, and 6 to 18 months
Child Dietary Intake - Variety of RED Foods Consumed
Time frame: Change from 0 to 6, and 6 to 18 months
Child Dietary Intake - Daily Servings of RED Foods
Time frame: Change from 0 to 6 and 6 to 18 months
Child Dietary Intake - Daily kcal From RED Foods
Time frame: Change from 0 to 6 and 6 to 18 months
Child Dietary Intake - Daily Energy
Time frame: Change from 0 to 6 and 6 to 18 months
Child Dietary Intake - Daily HEI
Time frame: Chage from 0 to 6 and 6 to 18 months
Child Physical Activity
Time frame: Change from 0 to 6, and 6 to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25496471Altman 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.
- Background: PubMed 19348547Epstein 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.
- Background: PubMed 19176724Epstein 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.
- Background: PubMed 18248101Temple 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.
- Background: PubMed 23085682Epstein 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.
- Background: PubMed 19649135Epstein 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.
- Background: PubMed 20010900Bond 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.
- Background: PubMed 19455371Bond 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.
- Background: PubMed 21593492Epstein 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.
- Background: PubMed 17459429Temple 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.
- Background: PubMed 22172456Aspen 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.
- Background: PubMed 25706950Epstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie Raynor, PhD RD LDN principal investigator
University of Tennessee Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FBT and FBT+Variety in people with Obesity and Childhood Obesity, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Body Mass Index (time frame: Change from 0 to 6, and 6 to 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027426, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.