Metabolic SyndromeNCT02023515
Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
A study testing Emotional brain training and Behavioral weight loss in people with Metabolic Syndrome, run by Kelly Webber at 1 site in United States.
Trial summary
The purpose of this study is to learn the impact stress may have on weight management and emotional eating. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Emotional brain training and Behavioral weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2014
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- be 25-55 years of age
- have a BMI of > 28 and <45
- meet criteria for at least one additional risk factor for metabolic syndrome (Participants will be screened for waist circumference and blood pressure to ensure inclusion in the study.)
- own and use a smart phone.
Who cannot join
- have a medical diagnosis of orthopedic or joint problems that may prohibit regular exercise
- endorse any of the first three items on the Physical Activity Readiness Questionnaire (PAR-Q): heart problems, chest pain, faintness or dizzy spells
- endorse any of the other items on the PAR-Q without a physician's consent
- have had a hospitalization for a psychiatric disorder within the last year
- have a history of anorexia or bulimia nervosa
- have a medical diagnosis of cancer or HIV
Show all 16Show fewer
- have a diagnosis of a major psychiatric disorder (i.e. bipolar disorder or schizophrenia) or taking anti-psychotic medications
- be pregnant, nursing, or planning to become pregnant within the study period
- be less than 9 months post-partum
- have a weight loss of > 10 pounds in the last six months
- be on more than two medications for hypertension control
- greater than stage 3 kidney disease
- be taking insulin to control diabetes
- be taking Coumadin
- be taking Lasix
- anyone, who in the opinion of the study investigators, would not be a good candidate for the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn the impact stress may have on weight management and emotional eating.
Read the detailed description
The investigator's long-term goal is to contribute to the development of empirically-based, clinically-useful weight loss and weight maintenance interventions. The objective in this application is to obtain proof of feasibility for a weight loss and maintenance intervention that addresses the underlying issue of stress, as an effective approach to long-term weight loss and maintenance. The central hypothesis for this application is that the weight management intervention utilizing stress management skills will produce weight loss and significant improvements in stress and metabolic syndrome biomarkers at 10 and 20 weeks follow-up. This hypothesis was formulated based upon data showing that stress is associated with increased risk of obesity and a few small studies that have shown this method of stress management can produce long-term weight loss and maintenance and decreased depression and stress. The rationale for the proposed studies is that proof of feasibility for such an intervention will enable subsequent definitive studies at the R01 level. If, however, the investigators were to unexpectedly disprove the concept, such a result would also be valuable because it would lead the investigators to shift focus and redistribute resources accordingly. To test the central hypothesis, and thereby accomplish the objective for this application, the following specific aims will be pursued:
- Compare a stress management based program to a standard behavioral weight loss program for weight loss and cost-effectiveness. The approach will involve two different intervention groups. Group 1(control) will receive a standard behavioral weight loss program. Group 2 will receive a stress management based intervention built on research in neuroscience and principles of the attachment theory.
- Determine secondary outcomes from both interventions, including stress as measured by the perceived stress scale. It is hypothesized that Group 2 will show greater improvements in stress at both 10 and 20 weeks follow-up than Group 1.
At the completion of this study, the investigators expect to determine the type of intervention that produces the greatest weight loss in a community sample at 10 and 20 weeks follow-up. The investigators will also have determined what impact the two interventions have on secondary outcomes, including stress as measured by salivary cortisol and telomere length; depression, disordered eating patterns, dietary intake, and physical activity.
- Conditions
- Metabolic Syndrome
- Being tested
- Emotional brain training, Behavioral weight loss
- Keywords
- weight loss, metabolic syndrome, stress, obesity
- Medical subject headings
- Metabolic Syndrome, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional brain trainingBehavioural
Stress management based program
Behavioral weight lossBehavioural
Standard behavioral weight loss
| Study group | Role | What they receive |
|---|---|---|
| Stress Management | Experimental | Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques. Receives: Behavioral: Emotional brain training |
| standard behavioral weight loss | Active comparator | Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks Receives: Behavioral: Behavioral weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Weight change from baseline to 20 weeks
Measured: Weight change from baseline to 20 weeks
Secondary outcomes (1)
Decrease in Stress
Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.
Measured: PSS change from baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2014
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.
- Other trials for Metabolic SyndromeStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kelly Webber
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Kelly Webber, University of Kentucky
- Investigators
- Kelly H Webber, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023515
- Sponsor's protocol ID
- 1R56HL116517-01A1
- Other IDs
- 1R56HL116517-01A1
- Status last verified
- May 2017
- First submitted
- 23 Dec 2013
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02023515
- Acronym / sponsor ID
- 1R56HL116517-01A1
- Conditions
- Metabolic Syndrome
- Keywords
- weight loss, metabolic syndrome, stress, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kelly WebberUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 27 Jun 2017
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 learn the impact stress may have on weight management and emotional eating.
Detailed description
The investigator's long-term goal is to contribute to the development of empirically-based, clinically-useful weight loss and weight maintenance interventions. The objective in this application is to obtain proof of feasibility for a weight loss and maintenance intervention that addresses the underlying issue of stress, as an effective approach to long-term weight loss and maintenance. The central hypothesis for this application is that the weight management intervention utilizing stress management skills will produce weight loss and significant improvements in stress and metabolic syndrome biomarkers at 10 and 20 weeks follow-up. This hypothesis was formulated based upon data showing that stress is associated with increased risk of obesity and a few small studies that have shown this method of stress management can produce long-term weight loss and maintenance and decreased depression and stress. The rationale for the proposed studies is that proof of feasibility for such an intervention will enable subsequent definitive studies at the R01 level. If, however, the investigators were to unexpectedly disprove the concept, such a result would also be valuable because it would lead the investigators to shift focus and redistribute resources accordingly. To test the central hypothesis, and thereby accomplish the objective for this application, the following specific aims will be pursued:
- Compare a stress management based program to a standard behavioral weight loss program for weight loss and cost-effectiveness. The approach will involve two different intervention groups. Group 1(control) will receive a standard behavioral weight loss program. Group 2 will receive a stress management based intervention built on research in neuroscience and principles of the attachment theory.
- Determine secondary outcomes from both interventions, including stress as measured by the perceived stress scale. It is hypothesized that Group 2 will show greater improvements in stress at both 10 and 20 weeks follow-up than Group 1.
At the completion of this study, the investigators expect to determine the type of intervention that produces the greatest weight loss in a community sample at 10 and 20 weeks follow-up. The investigators will also have determined what impact the two interventions have on secondary outcomes, including stress as measured by salivary cortisol and telomere length; depression, disordered eating patterns, dietary intake, and physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Management | Experimental | Behavioral: Emotional brain trainingApproximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques. |
| standard behavioral weight loss | Active comparator | Behavioral: Behavioral weight lossHalf of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- be 25-55 years of age
- have a BMI of > 28 and <45
- meet criteria for at least one additional risk factor for metabolic syndrome (Participants will be screened for waist circumference and blood pressure to ensure inclusion in the study.)
- own and use a smart phone.
Key exclusion criteria (16 listed)
- have a medical diagnosis of orthopedic or joint problems that may prohibit regular exercise
- endorse any of the first three items on the Physical Activity Readiness Questionnaire (PAR-Q): heart problems, chest pain, faintness or dizzy spells
- endorse any of the other items on the PAR-Q without a physician's consent
- have had a hospitalization for a psychiatric disorder within the last year
- have a history of anorexia or bulimia nervosa
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 |
|---|---|---|
| Emotional brain trainingStress management based program | Behavioural | Stress Management |
| Behavioral weight lossStandard behavioral weight loss | Behavioural | standard behavioral weight loss |
Primary outcome
Weight Loss
Time frame: Weight change from baseline to 20 weeks
Weight change from baseline to 20 weeks
1 secondary outcome
Decrease in Stress
Time frame: PSS change from baseline to 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelly H Webber, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional brain training and Behavioral weight loss in people with Metabolic Syndrome, run by Kelly Webber 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 4 inclusion and 16 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 27 Jun 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?
Yes. Results are posted in the registry (first posted 27 Jun 2017). 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?
Weight Loss (time frame: Weight change from baseline to 20 weeks). 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 27 Jun 2017.