Severe ObesityPREPNCT00623792
Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery
A study testing Preoperative lifestyle Intervention in people with Severe Obesity and Bariatric Surgery, run by Duquesne University at 1 site in United States.
Trial summary
The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Obesity, Bariatric Surgery
- What is being tested?
- Preoperative lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any candidate for weight loss surgery who is at least 18 years old [At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI > 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems]
Who cannot join
- Mental retardation or psychosis
- Previously diagnosed genetic obesity syndrome
- Participation in a structured weight management program in the 6 months prior to study enrollment
- Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment
- Pregnant or lactating in the previous 6 months
- Taking a medication known to affect body weight such as oral steroids in the previous 6 months
- Any previous surgery for weight loss
- Deemed high risk surgical candidate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Lifestyle Intervention in Bariatric Surgery
The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.
Read the detailed description
This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.
- Conditions
- Severe Obesity, Bariatric Surgery
- Being tested
- Preoperative lifestyle Intervention
- Keywords
- Morbid obesity, Diet therapy, Bariatric Surgery, Gastric bypass, Behavior therapy, Randomized controlled trial, Weight loss
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative lifestyle InterventionBehavioural
6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 "booster" telephone calls after surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual preoperative care |
| 2 | Experimental | Preoperative Lifestyle Intervention Receives: Behavioral: Preoperative lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight and related outcomes (BMI, cardiovascular risk, quality of life)
Measured: pre and post intervention
preparation for surgery (eating, activity and knowledge of surgery)
Measured: pre and post intervention
compliance and eating problems (vomiting, dumping, plugging etc.)
Measured: 6- and 12-months post surgery
surgical complications and outpatient visits
Measured: 6- and 12-months post surgery
Secondary outcomes (1)
Weight/BMI trajectory
Measured: pre- and post-intervention; 6-, 12 and 24 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2013
- Study completionDec 2013
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 Severe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Kalarchian, Duquesne University
- Investigators
- Melissa A Kalarchian, PhD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623792
- Sponsor's protocol ID
- R01DK077102-01A1
- Other IDs
- R01DK077102
- Acronym
- PREP
- Status last verified
- Mar 2016
- First submitted
- 14 Feb 2008
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Self-report of gastrointestinal side effects after bariatric surgery. Surg Obes Relat Dis. 2014 Nov-Dec;10(6):1202-7. doi: 10.1016/j.soard.2014.08.007. Epub 2014 Aug 23.
PubMed 25443069
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Lifestyle Intervention in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00623792
- Acronym / sponsor ID
- PREP / R01DK077102-01A1
- Conditions
- Severe Obesity, Bariatric Surgery
- Keywords
- Morbid obesity, Diet therapy, Bariatric Surgery, Gastric bypass, Behavior therapy, Randomized controlled trial, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2008 (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 the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.
Detailed description
This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual preoperative care |
| 2 | Experimental | Behavioral: Preoperative lifestyle InterventionPreoperative Lifestyle Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any candidate for weight loss surgery who is at least 18 years old [At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI > 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems]
Key exclusion criteria (8 listed)
- Mental retardation or psychosis
- Previously diagnosed genetic obesity syndrome
- Participation in a structured weight management program in the 6 months prior to study enrollment
- Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment
- Pregnant or lactating in the previous 6 months
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 |
|---|---|---|
| Preoperative lifestyle Intervention6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 "booster" telephone calls after surgery | Behavioural | 2 |
Primary outcome
weight and related outcomes (BMI, cardiovascular risk, quality of life)
Time frame: pre and post intervention
preparation for surgery (eating, activity and knowledge of surgery)
Time frame: pre and post intervention
compliance and eating problems (vomiting, dumping, plugging etc.)
Time frame: 6- and 12-months post surgery
surgical complications and outpatient visits
Time frame: 6- and 12-months post surgery
1 secondary outcome
Weight/BMI trajectory
Time frame: pre- and post-intervention; 6-, 12 and 24 months postop
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 17 Mar 2016.
- Derived from this study: PubMed 25443069Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Self-report of gastrointestinal side effects after bariatric surgery. Surg Obes Relat Dis. 2014 Nov-Dec;10(6):1202-7. doi: 10.1016/j.soard.2014.08.007. Epub 2014 Aug 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.
Melissa A Kalarchian, PhD principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative lifestyle Intervention in people with Severe Obesity and Bariatric Surgery, run by Duquesne 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 8 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 17 Mar 2016. 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 and related outcomes (BMI, cardiovascular risk, quality of life) (time frame: pre and post intervention). The study lists 4 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 NCT00623792, 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 17 Mar 2016.