ObesityROCNCT01442142
A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity
A study testing CAAT: Appetite Awareness, CRST: Volcravo and Combined CAAT and CRST program in people with Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this study is to pilot test, evaluate and compare the effects of Cue Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT) in 48 children aged 8-12 years old. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- CAAT: Appetite Awareness, CRST: Volcravo and Combined CAAT and CRST program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 2010
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Body Mass Index (BMI) greater than the 85%-ile
- child consumes 10%+ of daily caloric need during Eating in the absence of hunger (EAH) assessment
- child between the age of 8-12 at the time of the first data collection visit
Who cannot join
- non-English speaking
- history of eating disorder
- food allergies
- unavailable on days of intervention meetings
- current participation in a weight loss or maintenance program
- presence of any medical condition affecting weight or growth
- presence of any physical, emotional, or behavioral disability that would prevent participant from taking part in the weekly study visits or the three data collection visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Self-Regulation Treatment for Pediatric Obesity
The objective of this study is to pilot test, evaluate and compare the effects of Cue Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT) in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce eating in the absence of hunger in overweight children immediately following treatment and 6-months post treatment.
The primary aim of this proposed study is to evaluate the efficacy and compare the effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight children. Following this first intervention, a second intervention to determine the efficacy of a combination program (combined CAAT \& CRST) will be implemented.
The secondary aim of this study is to evaluate change in the following related measures for both children and adults who participated in CRST, CAAT, and the combination program: BMI for age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk food situations.
- Conditions
- Obesity
- Being tested
- CAAT: Appetite Awareness, CRST: Volcravo, Combined CAAT and CRST program
- Keywords
- obesity, pediatric, childhood, overweight
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAAT: Appetite AwarenessBehavioural
Participants in this Children's Appetite Awareness Training (CAAT) group learn to get in touch with the internal cues of hunger - aka the "hunger meter" - and practice skills to get back in touch with these internal cues of true hunger and fullness. Sessions occur once a week for 8 weeks.
CRST: VolcravoBehavioural
Participants in this Cue Reactivity and Sensitivity Training (CRST) group learn about how external cues can affect when and how much we eat (aka "volcravo - the craving volcano"). Over 8 weekly sessions, they practice skills to ride out the cravings external cues can cause.
Combined CAAT and CRST programBehavioural
Participants meet weekly for 14 weeks to learn about both Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST) - i.e. appetite awareness and external cues that affect food intake.
| Study group | Role | What they receive |
|---|---|---|
| Appetitie Awareness | Experimental | Parents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter." Receives: Behavioral: CAAT: Appetite Awareness |
| Cue Reactivity and Sensitivity Training | Experimental | Parents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues. Receives: Behavioral: CRST: Volcravo |
| Combined CAAT/CRST | Experimental | In this 14 week intervention combining Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST), parents and kids learn about both internal hunger cues and external cues that can cause one to overeat. Skills to learn the internal hunger cues and better responses to external cues are taught. Receives: Behavioral: Combined CAAT and CRST program |
| Control | No intervention | Between baseline and the post-intervention data collection point, no intervention is given. Participants are given a take home binder of intervention materials at that second data collection point; they have the option of reviewing the material prior to the final follow-up data collection point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months
Measured: Baseline and 3 months
Secondary outcomes (1)
Change from baseline in BMI-for-age at 3 months.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startMay 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 MinnesotaThe 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
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerri Boutelle, PhD, Principal investigator, University of Minnesota, now Univ of CA, San DiegoLisa J Harnack, DrPH, Principal investigator, University of MinnesotaCarol Peterson, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442142
- Sponsor's protocol ID
- AHC FRD 06-32
- Other IDs
- AHC FRD 06-32
- Acronym
- ROC
- Status last verified
- Sep 2017
- First submitted
- 2 Aug 2011
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.
PubMed 24459240
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Regulation Treatment for Pediatric Obesity
- ClinicalTrials.gov ID
- NCT01442142
- Acronym / sponsor ID
- ROC / AHC FRD 06-32
- Conditions
- Obesity
- Keywords
- obesity, pediatric, childhood, overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Sep 2011 (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 objective of this study is to pilot test, evaluate and compare the effects of Cue Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT) in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce eating in the absence of hunger in overweight children immediately following treatment and 6-months post treatment.
The primary aim of this proposed study is to evaluate the efficacy and compare the effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight children. Following this first intervention, a second intervention to determine the efficacy of a combination program (combined CAAT \& CRST) will be implemented.
The secondary aim of this study is to evaluate change in the following related measures for both children and adults who participated in CRST, CAAT, and the combination program: BMI for age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk food situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Appetitie Awareness | Experimental | Behavioral: CAAT: Appetite AwarenessParents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter." |
| Cue Reactivity and Sensitivity Training | Experimental | Behavioral: CRST: VolcravoParents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues. |
| Combined CAAT/CRST | Experimental | Behavioral: Combined CAAT and CRST programIn this 14 week intervention combining Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST), parents and kids learn about both internal hunger cues and external cues that can cause one to overeat. Skills to learn the internal hunger cues and better responses to external cues are taught. |
| Control | No intervention | –Between baseline and the post-intervention data collection point, no intervention is given. Participants are given a take home binder of intervention materials at that second data collection point; they have the option of reviewing the material prior to the final follow-up data collection point. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) greater than the 85%-ile
- child consumes 10%+ of daily caloric need during Eating in the absence of hunger (EAH) assessment
- child between the age of 8-12 at the time of the first data collection visit
Key exclusion criteria (7 listed)
- non-English speaking
- history of eating disorder
- food allergies
- unavailable on days of intervention meetings
- current participation in a weight loss or maintenance program
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 |
|---|---|---|
| CAAT: Appetite AwarenessParticipants in this Children's Appetite Awareness Training (CAAT) group learn to get in touch with the internal cues of hunger - aka the "hunger meter" - and practice skills to get back in touch with these internal cues of true hunger and fullness. Sessions occur once a week for 8 weeks. | Behavioural | Appetitie Awareness |
| CRST: VolcravoParticipants in this Cue Reactivity and Sensitivity Training (CRST) group learn about how external cues can affect when and how much we eat (aka "volcravo - the craving volcano"). Over 8 weekly sessions, they practice skills to ride out the cravings external cues can cause. | Behavioural | Cue Reactivity and Sensitivity Training |
| Combined CAAT and CRST programParticipants meet weekly for 14 weeks to learn about both Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST) - i.e. appetite awareness and external cues that affect food intake. | Behavioural | Combined CAAT/CRST |
Primary outcome
Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months
Time frame: Baseline and 3 months
1 secondary outcome
Change from baseline in BMI-for-age at 3 months.
Time frame: Baseline and 3 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 8 Sep 2017.
- Derived from this study: PubMed 24459240Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.
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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, PhD principal investigator
University of Minnesota, now Univ of CA, San Diego
Lisa J Harnack, DrPH principal investigator
University of Minnesota
Carol Peterson, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAAT: Appetite Awareness, CRST: Volcravo and Combined CAAT and CRST program in people with Obesity, run by University of Minnesota 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 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 8 Sep 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 from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months (time frame: Baseline and 3 months). 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 NCT01442142, which also lists 1 linked publication.
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 8 Sep 2017.