ObesityNCT02055391
A Weight Loss Trial for Emotional Eating
A study testing Behavioral Weight Loss and Enhanced Behavioral Weight Loss in people with Obesity, run by Temple University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral Weight Loss and Enhanced Behavioral Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2011
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smoker, free of diabetes, overweight and interested in losing weight, eat in response to emotions
Who cannot join
- Diabetes, any major medical or psychiatric condition that would compromise ability to participate, hypertension, current mental health treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Novel Weight Loss Intervention for Obesity
The purpose of this study is to determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions.
- Conditions
- Obesity
- Being tested
- Behavioral Weight Loss, Enhanced Behavioral Weight Loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight LossBehavioural
Weekly group meetings addressing behavioral weight loss skills including calorie counting, exercise, behavior modification, environmental changes, and coping with triggers.
Enhanced Behavioral Weight LossBehavioural
Weekly group meetings that combine behavioral weight loss skills (calorie counting, exercise, behavior modification, environmental changes) with skills to decrease emotional eating by learning ways to manage and cope with emotions without eating.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss | Active comparator | State of the art behavioral weight loss treatment Receives: Behavioral: Behavioral Weight Loss |
| Enhanced Behavioral Weight Loss | Experimental | Combines behavioral weight loss skills with skills specifically targeting emotional eating. Receives: Behavioral: Enhanced Behavioral Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Measured: 12 weeks and 20 weeks
Secondary outcomes (1)
changes in emotional eating
Measured: 12 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionFeb 2011
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.
- 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edie Goldbacher, Temple University
- Investigators
- Edie M Goldbacher, PhD, Principal investigator, Universidad La Salle, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055391
- Sponsor's protocol ID
- F32DK083910
- Status last verified
- Feb 2014
- First submitted
- 15 Aug 2011
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldbacher E, La Grotte C, Komaroff E, Vander Veur S, Foster GD. An initial evaluation of a weight loss intervention for individuals who engage in emotional eating. J Behav Med. 2016 Feb;39(1):139-50. doi: 10.1007/s10865-015-9678-6. Epub 2015 Sep 4.
PubMed 26341357
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Novel Weight Loss Intervention for Obesity
- ClinicalTrials.gov ID
- NCT02055391
- Acronym / sponsor ID
- F32DK083910
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Feb 2014 (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 determine whether a new weight loss treatment which incorporates behavioral weight loss skills and skills for learning how to identify, manage, and cope with emotions helps with weight loss and emotional eating in people who are overweight and eat in response to emotions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss | Active comparator | Behavioral: Behavioral Weight LossState of the art behavioral weight loss treatment |
| Enhanced Behavioral Weight Loss | Experimental | Behavioral: Enhanced Behavioral Weight LossCombines behavioral weight loss skills with skills specifically targeting emotional eating. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-smoker, free of diabetes, overweight and interested in losing weight, eat in response to emotions
Key exclusion criteria (1 listed)
- Diabetes, any major medical or psychiatric condition that would compromise ability to participate, hypertension, current mental health treatment
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 |
|---|---|---|
| Behavioral Weight LossWeekly group meetings addressing behavioral weight loss skills including calorie counting, exercise, behavior modification, environmental changes, and coping with triggers. | Behavioural | Behavioral Weight Loss |
| Enhanced Behavioral Weight LossWeekly group meetings that combine behavioral weight loss skills (calorie counting, exercise, behavior modification, environmental changes) with skills to decrease emotional eating by learning ways to manage and cope with emotions without eating. | Behavioural | Enhanced Behavioral Weight Loss |
Primary outcome
weight change
Time frame: 12 weeks and 20 weeks
1 secondary outcome
changes in emotional eating
Time frame: 12 weeks and 20 weeks
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 5 Feb 2014.
- Derived from this study: PubMed 26341357Goldbacher E, La Grotte C, Komaroff E, Vander Veur S, Foster GD. An initial evaluation of a weight loss intervention for individuals who engage in emotional eating. J Behav Med. 2016 Feb;39(1):139-50. doi: 10.1007/s10865-015-9678-6. Epub 2015 Sep 4.
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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.
Edie M Goldbacher, PhD principal investigator
Universidad La Salle, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Weight Loss and Enhanced Behavioral Weight Loss in people with Obesity, run by Temple University 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 5 Feb 2014. 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?
weight change (time frame: 12 weeks and 20 weeks). 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 NCT02055391, 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 5 Feb 2014.