ObesityNCT02496637
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen
A study testing Appetite Awareness and Nutrition Education in people with Obesity and Eating Disorders, run by University of Minnesota at 1 site in United States.
Trial summary
The proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women. It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group. Read more about this study
- Who is it for?
- Ages 18 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Disorders
- What is being tested?
- Appetite Awareness and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 1 Oct 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 18 to 20 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories
Who cannot join
- Males, non-dormitory residing, non-freshmen.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Duluth
Duluth, Minnesota, 55812
About this study
Official title: A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen: A Randomized Clinical Trial
The proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women. It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group. Appetite Awareness Training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.
Read the detailed description
All female freshmen students residing in the university dorms were recruited to participate in this study. After completing the baseline assessment, eligible participants were randomly assigned to one of the three arms. Those in the AAT condition received guided administration of AAT over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6). The standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician. A manualized approach to administration of the intervention was created based on the AAT treatment and was strictly followed in order to standardize the implementation of the prevention groups. The no-treatment control group only participated in the assessments.
- Conditions
- Obesity, Eating Disorders
- Being tested
- Appetite Awareness, Nutrition Education
- Keywords
- Obesity, Eating Disorders, Appetite regulation, Eating Regulation
- Medical subject headings
- Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appetite AwarenessBehavioural
Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues
Nutrition EducationBehavioural
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
| Study group | Role | What they receive |
|---|---|---|
| Appetite Awareness | Experimental | Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues Receives: Behavioral: Appetite Awareness |
| Nutrition Education | Active comparator | Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information. Receives: Behavioral: Nutrition Education |
| No Treatment Control | No intervention | No intervention, assessment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight measured in pounds
Measured: Baseline, 6 weeks, 4 months
Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)
Measured: Baseline, 6 weeks, 4 months
Secondary outcomes (2)
Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
Measured: 6 weeks, 4 months
Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire
Measured: 6 weeks, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara LaCaille, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496637
- Sponsor's protocol ID
- 1506S74643
- Status last verified
- Oct 2018
- First submitted
- 6 Jul 2015
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02496637
- Acronym / sponsor ID
- 1506S74643
- Conditions
- Obesity, Eating Disorders
- Keywords
- Obesity, Eating Disorders, Appetite regulation, Eating Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 14 Jul 2015 (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 proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women. It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group. Appetite Awareness Training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.
Detailed description
All female freshmen students residing in the university dorms were recruited to participate in this study. After completing the baseline assessment, eligible participants were randomly assigned to one of the three arms. Those in the AAT condition received guided administration of AAT over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6). The standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician. A manualized approach to administration of the intervention was created based on the AAT treatment and was strictly followed in order to standardize the implementation of the prevention groups. The no-treatment control group only participated in the assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Appetite Awareness | Experimental | Behavioral: Appetite AwarenessAppetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues |
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationNutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information. |
| No Treatment Control | No intervention | –No intervention, assessment only |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories
Key exclusion criteria (1 listed)
- Males, non-dormitory residing, non-freshmen.
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 |
|---|---|---|
| Appetite AwarenessAppetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues | Behavioural | Appetite Awareness |
| Nutrition EducationNutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information. | Behavioural | Nutrition Education |
Primary outcome
Change in Body Weight measured in pounds
Time frame: Baseline, 6 weeks, 4 months
Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)
Time frame: Baseline, 6 weeks, 4 months
2 secondary outcomes
Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
Time frame: 6 weeks, 4 months
Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire
Time frame: 6 weeks, 4 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 11 Oct 2018.
- 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.
Lara LaCaille, 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 Appetite Awareness and Nutrition Education in people with Obesity and Eating Disorders, 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 1 inclusion and 1 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 11 Oct 2018. 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 Body Weight measured in pounds (time frame: Baseline, 6 weeks, 4 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?
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 11 Oct 2018.