ObesityiROCNCT01708785
Learning Theory to Improve Obesity Treatment
A study testing Single food Cue Exposure Treatment, Multiple food Cue Exposure Treatment and Partial Reinforcement - Enhanced Cue Exposure Treatment in people with Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to optimize an obesity treatment program targeting overweight 8-12 year old children using "Cue Exposure Training". Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Single food Cue Exposure Treatment, Multiple food Cue Exposure Treatment and Partial Reinforcement - Enhanced Cue Exposure Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Response to an advertisement for the study,
- An overweight or obese child in the family who is between the ages of 8 and 13,
- The 8-13 year old child must be above the 85th BMI % for age and gender,
- Parent willing to participate and attend all meetings,
- Parent who can read at a minimum of a 5th grade level in English,
- Parent and child willing to commit to attendance and assessments,
- Child who eats in the absence of hunger.
Who cannot join
- Major child psychiatric disorder diagnoses,
- An obese child over the 99.9th BMI %
- Child or parent diagnoses of diabetes for which physician supervision of diet is needed or diagnosis of serious current physical diseases (such as cancer, multiple sclerosis, lupus) which could significantly decrease their ability to participate in the intervention (parent report),
- Child taking a medication that can affect cognitive functioning, such as attention, concentration, or mental status.
- Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home (these restrictions affect their ability participate in the food exposures because it would limit the variety of foods available to do exposures with),
- Child with an active eating disorder (based on parent and child self-report)
- Major parent psychiatric or eating disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Health Eating and Activity Research
La Jolla, California, 92037
About this study
Official title: Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)
The purpose of this study is to optimize an obesity treatment program targeting overweight 8-12 year old children using "Cue Exposure Training".
Read the detailed description
The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy foods. Through a series of experimental studies, the investigators will evaluate how many weekly treatment visits there should be, whether children should be exposed to a single food or multiple foods during treatment, whether to use partial reinforcement or not, whether visits should be daily or weekly, and whether the exposures should be in single or multiple contexts. The investigators will be recruiting parent-child dyads in the San Diego community to participate in 8 to 16 weekly or daily treatment sessions either in their home, community center, or our lab, depending on the treatment arm. Parents and children will complete baseline and post-treatment assessments consisting of collecting psychophysiological data, completing laboratory tasks, and completing questionnaires. The investigators will be evaluating which treatment condition reduces overeating (as measured by our laboratory tasks).
- Conditions
- Obesity
- Being tested
- Single food Cue Exposure Treatment, Multiple food Cue Exposure Treatment, Partial Reinforcement - Enhanced Cue Exposure Treatment, Partial Reinforcement -Consistent Cue Exposure Treatment
- Keywords
- obesity, overweight, overweight children, overweight parents, overeating, eating in the absence of hunger, families with overweight child, body mass index, BMI, weight, childhood obesity, treatment, cue exposure treatment, cravings, habituation to food cues, psychophysiological response to food cues, intervention, experiments, family based treatment, behavioral treatment
- Medical subject headings
- Obesity, Overweight, Hyperphagia, Body Weight, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single food Cue Exposure TreatmentBehavioural
Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
Multiple food Cue Exposure TreatmentBehavioural
Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
Partial Reinforcement - Enhanced Cue Exposure TreatmentBehavioural
Subjects will take random additional tastes of the food during cue exposure treatment.
Partial Reinforcement -Consistent Cue Exposure TreatmentBehavioural
Subjects will consistently take the same tastes of the food during cue exposure treatment.
| Study group | Role | What they receive |
|---|---|---|
| Single context | Active comparator | Subjects will be exposed to food cues in a single context. Receives: Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment; Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment |
| Multiple contexts | Experimental | Subjects will be exposed to food cues in multiple contexts. Receives: Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment; Behavioral: Partial Reinforcement -Consistent Cue Exposure Treatment |
| 8 treatment sessions | Active comparator | Subjects receive 8 treatment sessions. Receives: Behavioral: Single food Cue Exposure Treatment; Behavioral: Multiple food Cue Exposure Treatment |
| 16 treatment sessions | Experimental | Subjects receive 16 treatment sessions Receives: Behavioral: Single food Cue Exposure Treatment; Behavioral: Multiple food Cue Exposure Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months
Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.
Measured: Change from baseline at an average of 3 months and 6 months
Change in child weight
BMI, BMIz
Measured: Change from baseline at an average of 3 and 6 months
Secondary outcomes (5)
Change in parent weight from baseline at average of 3 and 6 months
Measured by BMI (Body Mass Index)
Measured: Change from baseline at average of 3 and 6 months
Change in attention to food cues from baseline at average of 3 and 6 months
Reduce attention to food cues, redirect attention to neutral (non-food cues). Measured by computer program measuring response time
Measured: Change from baseline at average of 3 and 6 months
Change in impulsivity/Inhibition from baseline at average of 3 and 6 months
Reduce impulsive behavior response to both food and non-food cues. Measured by behavioral tasks
Measured: Change from baseline at average of 3 and 6 months
Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months
Salivation/swallowing using EMG (electromyography), skin conductance, heart rate and heart rate variability.
Measured: Change from baseline at average of 3 and 6 months
Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months
Participants will rate their cravings on a scale of 1-10.
Measured: Change from baseline at average of 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708785
- Sponsor's protocol ID
- 120431
- Other IDs
- 1R01DK094475-01A1
- Acronym
- iROC
- Status last verified
- Oct 2017
- First submitted
- 11 Oct 2012
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
PubMed 22122291Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
PubMed 12224662Nederkoorn C, Smulders FT, Jansen A. Cephalic phase responses, craving and food intake in normal subjects. Appetite. 2000 Aug;35(1):45-55. doi: 10.1006/appe.2000.0328.
PubMed 10896760Nederkoorn C, Jansen A. Cue reactivity and regulation of food intake. Eat Behav. 2002 Spring;3(1):61-72. doi: 10.1016/s1471-0153(01)00045-9.
PubMed 15001020
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Theory to Improve Obesity Treatment (Intervention for Regulation of Cues)
- ClinicalTrials.gov ID
- NCT01708785
- Acronym / sponsor ID
- iROC / 120431
- Conditions
- Obesity
- Keywords
- obesity, overweight, overweight children, overweight parents, overeating, eating in the absence of hunger, families with overweight child, body mass index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to optimize an obesity treatment program targeting overweight 8-12 year old children using "Cue Exposure Training".
Detailed description
The goal of the Cue Exposure program is to train children to resist cues to eat unhealthy foods. Through a series of experimental studies, the investigators will evaluate how many weekly treatment visits there should be, whether children should be exposed to a single food or multiple foods during treatment, whether to use partial reinforcement or not, whether visits should be daily or weekly, and whether the exposures should be in single or multiple contexts. The investigators will be recruiting parent-child dyads in the San Diego community to participate in 8 to 16 weekly or daily treatment sessions either in their home, community center, or our lab, depending on the treatment arm. Parents and children will complete baseline and post-treatment assessments consisting of collecting psychophysiological data, completing laboratory tasks, and completing questionnaires. The investigators will be evaluating which treatment condition reduces overeating (as measured by our laboratory tasks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single context | Active comparator | Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment, Behavioral: Partial Reinforcement -Consistent Cue Exposure TreatmentSubjects will be exposed to food cues in a single context. |
| Multiple contexts | Experimental | Behavioral: Partial Reinforcement - Enhanced Cue Exposure Treatment, Behavioral: Partial Reinforcement -Consistent Cue Exposure TreatmentSubjects will be exposed to food cues in multiple contexts. |
| 8 treatment sessions | Active comparator | Behavioral: Single food Cue Exposure Treatment, Behavioral: Multiple food Cue Exposure TreatmentSubjects receive 8 treatment sessions. |
| 16 treatment sessions | Experimental | Behavioral: Single food Cue Exposure Treatment, Behavioral: Multiple food Cue Exposure TreatmentSubjects receive 16 treatment sessions |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Response to an advertisement for the study,
- An overweight or obese child in the family who is between the ages of 8 and 13,
- The 8-13 year old child must be above the 85th BMI % for age and gender,
- Parent willing to participate and attend all meetings,
- Parent who can read at a minimum of a 5th grade level in English,
Key exclusion criteria (7 listed)
- Major child psychiatric disorder diagnoses,
- An obese child over the 99.9th BMI %
- Child or parent diagnoses of diabetes for which physician supervision of diet is needed or diagnosis of serious current physical diseases (such as cancer, multiple sclerosis, lupus) which could significantly decrease their ability to participate in the intervention (parent report),
- Child taking a medication that can affect cognitive functioning, such as attention, concentration, or mental status.
- Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home (these restrictions affect their ability participate in the food exposures because it would limit the variety of foods available to do exposures with),
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 |
|---|---|---|
| Single food Cue Exposure TreatmentSubjects will be exposed to the same set of 4 foods in each cue exposure treatment session. | Behavioural | 16 treatment sessions, 8 treatment sessions |
| Multiple food Cue Exposure TreatmentSubjects will be exposed to a different set of 4 foods in each cue exposure treatment session. | Behavioural | 16 treatment sessions, 8 treatment sessions |
| Partial Reinforcement - Enhanced Cue Exposure TreatmentSubjects will take random additional tastes of the food during cue exposure treatment. | Behavioural | Multiple contexts, Single context |
| Partial Reinforcement -Consistent Cue Exposure TreatmentSubjects will consistently take the same tastes of the food during cue exposure treatment. | Behavioural | Multiple contexts, Single context |
Primary outcome
Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months
Time frame: Change from baseline at an average of 3 months and 6 months
Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.
Change in child weight
Time frame: Change from baseline at an average of 3 and 6 months
BMI, BMIz
5 secondary outcomes
Change in parent weight from baseline at average of 3 and 6 months
Time frame: Change from baseline at average of 3 and 6 months
Change in attention to food cues from baseline at average of 3 and 6 months
Time frame: Change from baseline at average of 3 and 6 months
Change in impulsivity/Inhibition from baseline at average of 3 and 6 months
Time frame: Change from baseline at average of 3 and 6 months
Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months
Time frame: Change from baseline at average of 3 and 6 months
Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months
Time frame: Change from baseline at average of 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Background: PubMed 22122291Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.
- Background: PubMed 12224662Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.
- Background: PubMed 10896760Nederkoorn C, Smulders FT, Jansen A. Cephalic phase responses, craving and food intake in normal subjects. Appetite. 2000 Aug;35(1):45-55. doi: 10.1006/appe.2000.0328.
- Background: PubMed 15001020Nederkoorn C, Jansen A. Cue reactivity and regulation of food intake. Eat Behav. 2002 Spring;3(1):61-72. doi: 10.1016/s1471-0153(01)00045-9.
- 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.
Kerri Boutelle, Ph.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single food Cue Exposure Treatment, Multiple food Cue Exposure Treatment and Partial Reinforcement - Enhanced Cue Exposure Treatment in people with Obesity, run by University of California, San Diego 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 7 inclusion and 7 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 18 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months (time frame: Change from baseline at an average of 3 months and 6 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 NCT01708785, which also lists 4 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 18 Oct 2017.