ObesityPhase 4NCT00143962
Comparison of Two Approaches to Weight Loss Follow-Up Study
A Phase 4 study testing Low Carbohydrate Diet in people with Obesity, run by University of Pennsylvania at 3 sites in United States.
Trial summary
This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Low Carbohydrate Diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2004to Mar 2006
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status Exclusion criteria
- History of heart disease, heart attack, or stroke
- Blood pressure >140/90 mmHg
- Abnormal cholesterol levels
Show all 18Show fewer
- Significant psychiatric illness
- Any medication that affects weight or metabolic rate
- Presence or history of a chronic disease that is known to affect appetite, food intake, or metabolism (i.e., diabetes, thyroid disease, or cancer)
- Currently using antidepressants, steroids, tobacco, or illegal drugs
- Pregnant, breastfeeding, or planning pregnancy
- 10 lb change in weight within 6 months of study entry
- History of malignant arrhythmias or cerebrovascular, renal, or hepatic disease
- History of protein wasting diseases or gout
- Severe arthritis
- Osteoporosis
- Certain types of hormone replacement therapy
- Currently following a vegetarian diet
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado
Denver, Colorado
University of Pennsylvania
Philadelphia, Pennsylvania
Washington University
St Louis, Missouri
About this study
This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet.
We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.
Read the detailed description
*PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study*
- Conditions
- Obesity
- Being tested
- Low Carbohydrate Diet
- Keywords
- 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.
Low Carbohydrate DietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionMar 2006
- Study completionMar 2006
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 PennsylvaniaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Gary Foster, PhD, Principal investigator, University of PennsylvaniaHolly Wyatt, MD, Principal investigator, University of Colorado, DenverJames Hill, PhD, Principal investigator, University of Colorado, DenverSamuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143962
- Sponsor's protocol ID
- 801787
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2005
- Last updated
- 17 Aug 2016
- Results posted
- No
Publications
Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.
PubMed 12761365
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Approaches to Weight Loss Follow-Up Study
- ClinicalTrials.gov ID
- NCT00143962
- Acronym / sponsor ID
- 801787
- Conditions
- Obesity
- Keywords
- Weight Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Sep 2005 (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.
This is a follow-up research study to determine if there are any differences in the long-term maintenance of two diet groups, the Atkins' diet (low-carbohydrate) or the LEARN program (low-fat). The Atkins' diet continues to get a significant amount of popular attention and very little scientific evaluation. Due to the small amount of scientific data to support a low-carbohydrate diet and given the wide spread use of this type of diet, it is important to evaluate the long-term safety and effectiveness of the Atkins' diet.
We will evaluate whether there are any differences between these two groups 3-years after participation in the initial 1-year study period. We will specifically assess weight, cholesterol levels, glucose and insulin levels, and eating habits and mood as we did originally.
Detailed description
*PLEASE NOTE: Only those who participated in the original study of low carbohydrate and low fat diets are eligable for enrollment in this follow-up study*
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Body mass index between 30 and 40
- Live and work within 1 hour of the study site
- Stable psychological status Exclusion criteria
- History of heart disease, heart attack, or stroke
- Blood pressure >140/90 mmHg
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Low Carbohydrate Diet | Behavioural | – |
Primary outcome
Obesity
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 Aug 2016.
- Background: PubMed 12761365Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.
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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.
Gary Foster, PhD principal investigator
University of Pennsylvania
Holly Wyatt, MD principal investigator
University of Colorado, Denver
James Hill, PhD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low Carbohydrate Diet in people with Obesity, run by University of Pennsylvania at 3 sites 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 18 inclusion and 0 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Obesity. 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 NCT00143962, 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 Aug 2016.