ObesityWORLDNCT00847574
The WORLD (Weight Optimization: Revamping Lifestyles Using the Dietary Guidelines) Study - Developing, Implementing, and Testing an Education Program
A study testing Moderate-fat and Lower-fat in people with Obesity and Cardiovascular Disease, run by Penn State University at 1 site in United States.
Trial summary
The WORLD study is a single-center, year-long randomized controlled trial in free-living women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a moderate-fat (MF) diet for weight management in a parallel-arm design. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Disease
- What is being tested?
- Moderate-fat and Lower-fat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2010
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-50 years
- BMI: 25-39.9 kg/m2
- LDL-C: 100-189.9 mg/dL
Who cannot join
- Triglycerides > 350 mg/dL
- History of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease
- High alcohol consumption (<14 drinks/week)
- Use of medication or supplements for lowering blood lipid levels (i.e., statin, fibrates, psyllium, fish oil capsules, soy lecithin, phytoestrogens)
- Lactating, pregnant, or wanting to become pregnant during the study
- Weight loss or gain ≥ 10% body weight in the previous 6 months
Show all 10Show fewer
- Eating Attitudes Test-26 score > 20
- Beck Depression Inventory-II score ≥ 29
- Gormally Cognitive Factors Related to Binge Eating Scale score > 30
- Physical Activity Readiness Questionnaire score > 2
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women
The WORLD study is a single-center, year-long randomized controlled trial in free-living women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1). During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through 12, participants shifted into weight maintenance. It was hypothesized that a weight-loss intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines would be equally effective for weight loss while achieving comparable nutrient adequacy. Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate, based on the Healthy Eating Index.
- Conditions
- Obesity, Cardiovascular Disease
- Being tested
- Moderate-fat, Lower-fat
- Keywords
- Weight loss, Weight maintenance, Weight management, Cardiovascular disease risk, Dietary Guidelines, Diet and exercise, Prevention
- Medical subject headings
- Obesity, Cardiovascular Diseases, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-fatBehavioural
35% of calories from fat
Lower-fatBehavioural
20% of calories from fat
| Study group | Role | What they receive |
|---|---|---|
| Moderate-fat | Experimental | 35% of calories from fat Receives: Behavioral: Moderate-fat |
| Lower-fat | Experimental | 20% of calories from fat Receives: Behavioral: Lower-fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: Baseline, month 4, month 8, month 12
Secondary outcomes (8)
Lipid Profile
Measured: Baseline, month 4, month 8, month 12
Glucose
Measured: Baseline, month 4, month 8, month 12
Insulin
Measured: Baseline, month 4, month 8, month 12
C-reactive protein
Measured: Baseline, month 4, month 8, month 12
Dietary intake
Measured: Baseline, month 4, month 12
Body composition
Measured: Baseline, month 4, month 12
Fitness via VO2max
Measured: Baseline, month 4, month 12
Cognitive-behavioral measures
Measured: Baseline, month 4, month 8, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2006
- Primary completionJun 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Penny M Kris-Etherton, PhD, RD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847574
- Sponsor's protocol ID
- WORLD Study
- Other IDs
- USDA CSREES #2005-55215-04811
- Acronym
- WORLD
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2009
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation, & Testing and Education Program to Teach Weight Loss Using the 2005 Dietary Guidelines to Pre-Menopausal Women
- ClinicalTrials.gov ID
- NCT00847574
- Acronym / sponsor ID
- WORLD / WORLD Study
- Conditions
- Obesity, Cardiovascular Disease
- Keywords
- Weight loss, Weight maintenance, Weight management, Cardiovascular disease risk, Dietary Guidelines, Diet and exercise, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Mar 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Feb 2009 (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 WORLD study is a single-center, year-long randomized controlled trial in free-living women. Participants were randomly assigned to follow either a lower-fat (LF) diet or a moderate-fat (MF) diet for weight management in a parallel-arm design. The two phases of the study were a weight-loss phase (phase 1) and a weight-maintenance phase (phase 2) (Figure 1). During phase 1, months 1 through 4, participants consumed a hypo-caloric diet consistent with the 2005 Dietary Guidelines in the free-living environment. During phase 2, months 5 through 12, participants shifted into weight maintenance. It was hypothesized that a weight-loss intervention at the extremes of dietary fat recommendations of the 2005 Dietary Guidelines would be equally effective for weight loss while achieving comparable nutrient adequacy. Also, Overall, the lower-fat and moderate-fat diets would both be nutritionally adequate, based on the Healthy Eating Index.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-fat | Experimental | Behavioral: Moderate-fat35% of calories from fat |
| Lower-fat | Experimental | Behavioral: Lower-fat20% of calories from fat |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21-50 years
- BMI: 25-39.9 kg/m2
- LDL-C: 100-189.9 mg/dL
Key exclusion criteria (10 listed)
- Triglycerides > 350 mg/dL
- History of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease
- High alcohol consumption (<14 drinks/week)
- Use of medication or supplements for lowering blood lipid levels (i.e., statin, fibrates, psyllium, fish oil capsules, soy lecithin, phytoestrogens)
- Lactating, pregnant, or wanting to become pregnant during the study
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 |
|---|---|---|
| Moderate-fat35% of calories from fat | Behavioural | Moderate-fat |
| Lower-fat20% of calories from fat | Behavioural | Lower-fat |
Primary outcome
Body weight
Time frame: Baseline, month 4, month 8, month 12
8 secondary outcomes
Lipid Profile
Time frame: Baseline, month 4, month 8, month 12
Glucose
Time frame: Baseline, month 4, month 8, month 12
Insulin
Time frame: Baseline, month 4, month 8, month 12
C-reactive protein
Time frame: Baseline, month 4, month 8, month 12
Dietary intake
Time frame: Baseline, month 4, month 12
Body composition
Time frame: Baseline, month 4, month 12
Fitness via VO2max
Time frame: Baseline, month 4, month 12
Cognitive-behavioral measures
Time frame: Baseline, month 4, month 8, month 12
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 18 Aug 2023.
- Related InfoLink provided by the sponsor.
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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.
Penny M Kris-Etherton, PhD, RD principal investigator
Penn State 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 Moderate-fat and Lower-fat in people with Obesity and Cardiovascular Disease, run by Penn State 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 3 inclusion and 10 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 18 Aug 2023. 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?
Body weight (time frame: Baseline, month 4, month 8, month 12). 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 18 Aug 2023.