HypercholesterolemiaNCT00074633
Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
A study testing Health at Every Size (HAES) and Diet (Traditional, moderate energy restriction) in people with Hypercholesterolemia and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.
Trial summary
Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hypertension, Depression
- What is being tested?
- Health at Every Size (HAES) and Diet (Traditional, moderate energy restriction)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2000to not given
- 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 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
- Caucasian;
- female;
- age 30-45 years;
- Body Mass Index (BMI)>30 m/kg2;
- non-smoker;
- not pregnant or lactating;
- Restraint Scale (Herman and Polivy, 1988) score >15, indicating a history of chronic dieting;
- no recent myocardial infarction;
- no active neoplasms, Type 1 diabetes or insulin-dependent Type 2 diabetes, nor history of cerebrovascular or renal disease.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nutrition Department, University of California, Davis
Davis, California, 95616
Western Human Nutrition Research Center
Davis, California, 95616
About this study
Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. There is little data to show improved long term success for the majority of participants who engage in weight loss behaviors.
The specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging "Health at Every Size" (HAES). This treatment model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). The HAES model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.
- Being tested
- Health at Every Size (HAES), Diet (Traditional, moderate energy restriction)
- Keywords
- Type 2 Diabetes, Self-Esteem
- Medical subject headings
- Hypercholesterolemia, Hypertension, Depression, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health at Every Size (HAES)Behavioural
Diet (Traditional, moderate energy restriction)Behavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2003 (estimated)
- Study startJan 2000
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 HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, Davis, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074633
- Sponsor's protocol ID
- OBFRETTO (completed)
- Status last verified
- Jan 2010
- First submitted
- 17 Dec 2003
- Last updated
- 13 Jan 2010
- Results posted
- No
Publications
Bacon L, Keim NL, Van Loan MD, Derricote M, Gale B, Kazaks A, Stern JS. Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. Int J Obes Relat Metab Disord. 2002 Jun;26(6):854-65. doi: 10.1038/sj.ijo.0802012.
PubMed 12037657
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
- ClinicalTrials.gov ID
- NCT00074633
- Acronym / sponsor ID
- OBFRETTO (completed)
- Keywords
- Type 2 Diabetes, Self-Esteem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of California, Davis, United States Department of Agriculture (USDA)
- Study start
- Jan 2000
- First posted
- 19 Dec 2003 (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.
Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. There is little data to show improved long term success for the majority of participants who engage in weight loss behaviors.
The specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging "Health at Every Size" (HAES). This treatment model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). The HAES model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Health at Every Size (HAES) | Behavioural | – |
| Diet (Traditional, moderate energy restriction) | Behavioural | – |
Primary outcome
Not reported in the source record.
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 13 Jan 2010.
- Background: PubMed 12037657Bacon L, Keim NL, Van Loan MD, Derricote M, Gale B, Kazaks A, Stern JS. Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. Int J Obes Relat Metab Disord. 2002 Jun;26(6):854-65. doi: 10.1038/sj.ijo.0802012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health at Every Size (HAES) and Diet (Traditional, moderate energy restriction) in people with Hypercholesterolemia and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 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?
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 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00074633, 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 13 Jan 2010.