ObesityLose-ItNCT00429650
Using the Energy Gap to Prevent Weight Regain
A study testing increased exercise, diet and Exercise and Diet in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- increased exercise, diet and Exercise and Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2014
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All ethnic groups and both genders
- Age: Lower age limit: 19 years; Upper age limit: 45 years
- Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)
- A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.
Who cannot join
- History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg)
- Currently smoking or stopped smoking in the last 12 months
- Medications affecting weight, energy intake, or energy expenditure in the last 6 months
- Use of oral steroids within the last 12 months
- History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
- Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma
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- Infectious diseases: Self-reported HIV positivity or Active tuberculosis
- Weight loss or weight gain of > 5% in past 6 months for any reason except post-partum weight loss
- Likely to move away in next 1.5 years
- Inability to adhere to the program such as inability to increase walking
- Currently pregnant, lactating or less than 6 months post-partum
- Major psychiatric disorder: Exclusions related to medications -Antipsychotic agents (these include, but are not limited to: Haldol, Loxitane, Mellaril, Navane, Prolixin, Stelazine, Thorazine, and Trilafon)
- Current depression by history or Beck Depression Inventory (BDI)
- Currently being treated for psychological condition
Trial locations and contacts
1 site in 1 country.
About this study
The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.
- Conditions
- Obesity
- Being tested
- increased exercise, diet, Exercise and Diet
- Keywords
- Weight maintenance, Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
increased exerciseBehavioural
Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.
dietBehavioural
Use a prescribed diet to maintain weight loss
Exercise and DietBehavioural
Use a combination of exercise and diet to maintain weight loss.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Increased amount of exercise to maintain weight loss. Receives: Behavioral: increased exercise |
| 2 | Experimental | Combination of Exercise and Diet to maintain weight loss Receives: Behavioral: Exercise and Diet |
| 3 | Active comparator | Use diet alone to maintain weight loss. Receives: Behavioral: diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2014
- Study completionJan 2014
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 Colorado, DenverThe 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
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly R. Wyatt, MD, Principal investigator, University of Colorado at Denver Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429650
- Sponsor's protocol ID
- 06-0369
- Other IDs
- R01DK071692
- Acronym
- Lose-It
- Status last verified
- Jun 2019
- First submitted
- 30 Jan 2007
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Polsky S, Garratt Ogden L, Scown Maclean P, Danielle Giles E, Brill C, Roxanna Wyatt H. Biomarker Profile Does Not Predict Weight Loss Success in Successful and Unsuccessful Diet-Reduced Obese Individuals: a Prospective Study. ISRN Obes. 2013 Jan 1;2013:804129. doi: 10.1155/2013/804129.
PubMed 24363955
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Energy Gap to Prevent Weight Regain
- ClinicalTrials.gov ID
- NCT00429650
- Acronym / sponsor ID
- Lose-It / 06-0369
- Conditions
- Obesity
- Keywords
- Weight maintenance, Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Feb 2007 (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 major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: increased exerciseIncreased amount of exercise to maintain weight loss. |
| 2 | Experimental | Behavioral: Exercise and DietCombination of Exercise and Diet to maintain weight loss |
| 3 | Active comparator | Behavioral: dietUse diet alone to maintain weight loss. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All ethnic groups and both genders
- Age: Lower age limit: 19 years; Upper age limit: 45 years
- Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)
- A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.
Key exclusion criteria (14 listed)
- History of cardiovascular disease, including coronary artery disease, congestive heart failure, \& unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg)
- Currently smoking or stopped smoking in the last 12 months
- Medications affecting weight, energy intake, or energy expenditure in the last 6 months
- Use of oral steroids within the last 12 months
- History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias
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 |
|---|---|---|
| increased exerciseUse prescribed number of minutes of exercise 5-6 days per week to maintain weight loss. | Behavioural | 1 |
| dietUse a prescribed diet to maintain weight loss | Behavioural | 3 |
| Exercise and DietUse a combination of exercise and diet to maintain weight loss. | Behavioural | 2 |
Primary outcome
Change in Weight
Time frame: 18 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 28 Jun 2019.
- Derived from this study: PubMed 24363955Polsky S, Garratt Ogden L, Scown Maclean P, Danielle Giles E, Brill C, Roxanna Wyatt H. Biomarker Profile Does Not Predict Weight Loss Success in Successful and Unsuccessful Diet-Reduced Obese Individuals: a Prospective Study. ISRN Obes. 2013 Jan 1;2013:804129. doi: 10.1155/2013/804129.
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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.
Holly R. Wyatt, MD principal investigator
University of Colorado at Denver Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing increased exercise, diet and Exercise and Diet in people with Obesity, run by University of Colorado, Denver 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 14 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 28 Jun 2019. 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 Weight (time frame: 18 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 NCT00429650, 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 28 Jun 2019.