Diabetes or Diabetes PreventionPhase 2EWLWNCT00561158
Eat Well Live Well Nutrition Program
A Phase 2 study testing Eat Well Live Well Nutrition Program in people with Diabetes or Diabetes Prevention, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
The purpose of the study is to develop and evaluate a dietary change program specifically for low-income, African-American women who are at risk for developing diabetes due to obesity. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes or Diabetes Prevention
- What is being tested?
- Eat Well Live Well Nutrition Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- Jun 1994to May 1998
- Phase
- Phase 2
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- African-American Women
- Aged 25-55 years
- No current diabetes, obese (20% over ideal body weight)
- In community neighborhoods
Who cannot join
None listed.
About this study
Official title: Dietary Changes in African American Women By Activation
The purpose of the study is to develop and evaluate a dietary change program specifically for low-income, African-American women who are at risk for developing diabetes due to obesity. The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and skills training through active learning exercises related to healthy eating. The program is delivered by peer educators in the community and addresses economic and cultural factors that are very important to program participants.
- Conditions
- Diabetes or Diabetes Prevention
- Being tested
- Eat Well Live Well Nutrition Program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eat Well Live Well Nutrition ProgramBehavioural
12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information.
The group sessions included are:
- Rate Your Plate: determining high fat foods
- Label Reading: reading food labels
- Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income
- Recipe Modification: preparing old recipes in new ways to reduce fat
- Eating Out: order healthier fast foods
- Coping with High Risk Situations: coping with situations in which these new habits may be threatened
Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including:
- Substituting fat-modified foods for high fat foods
- Avoiding fat as a seasoning or flavoring
- Avoiding fried foods
- Modifying meat
- Replacing high fat foods with fruits, vegetables, grains and breads
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: Eat Well Live Well Nutrition Program |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight & Body Mass Index (BMI)
Measured: pre-, post and three month follow-up
Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.
Secondary outcomes (5)
Depressive symptoms (C-ESD)
Measured: pre-, post and three month follow-up
Dietary Knowledge: ten items that test knowledge of: i) fat in foods that are specific to target population; ii) Label Reading; iii) modifying recipes to lower fat content; and iv) saturated versus unsaturated fats
Measured: pre-, post and three month follow-up
Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry
Measured: pre-, post and three month follow-up
Attitudes about fat in diet
Cultural relevancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startJun 1994
- Study completionMay 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes or Diabetes PreventionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- St. Louis University, Grace Hill Health Centers, Inc.
- Investigators
- Wendy F Auslander, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561158
- Sponsor's protocol ID
- DK48134 (completed)
- Other IDs
- R01DK048143
- Acronym
- EWLW
- Status last verified
- Jan 2010
- First submitted
- 19 Nov 2007
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Changes in African American Women By Activation
- ClinicalTrials.gov ID
- NCT00561158
- Acronym / sponsor ID
- EWLW / DK48134 (completed)
- Conditions
- Diabetes or Diabetes Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- St. Louis University, Grace Hill Health Centers, Inc.
- Study start
- Jun 1994
- Study completion
- May 1998 (actual)
- First posted
- 20 Nov 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 purpose of the study is to develop and evaluate a dietary change program specifically for low-income, African-American women who are at risk for developing diabetes due to obesity. The program uses an innovative approach that emphasizes risk awareness, self-efficacy, and skills training through active learning exercises related to healthy eating. The program is delivered by peer educators in the community and addresses economic and cultural factors that are very important to program participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Eat Well Live Well Nutrition Program |
| 2 | No intervention | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- African-American Women
- Aged 25-55 years
- No current diabetes, obese (20% over ideal body weight)
- In community neighborhoods
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 |
|---|---|---|
| Eat Well Live Well Nutrition Program12 sessions (6 group and 6 individual)over a period of 3 months with a 3 month follow-up period. The group sessions involve active learning exercises crucial to learning and utilizing nutrition information. The group sessions included are: * Rate Your Plate: determining high fat foods * Label Reading: reading food labels * Comparison Shopping: using unit pricing labels maximize nutritional value on a limited income * Recipe Modification: preparing old recipes in new ways to reduce fat * Eating Out: order healthier fast foods * Coping with High Risk Situations: coping with situations in which these new habits may be threatened Six individual sessions will introduce participants to low fat eating patterns or ways to lower fat in their diet, including: * Substituting fat-modified foods for high fat foods * Avoiding fat as a seasoning or flavoring * Avoiding fried foods * Modifying meat * Replacing high fat foods with fruits, vegetables, grains and breads | Behavioural | A |
Primary outcome
Weight & Body Mass Index (BMI)
Time frame: pre-, post and three month follow-up
Fat intake (measured by Food Frequency Questionnaire) including: percent calories from fat, percent calories from saturated fat.
5 secondary outcomes
Depressive symptoms (C-ESD)
Time frame: pre-, post and three month follow-up
Dietary Knowledge: ten items that test knowledge of: i) fat in foods that are specific to target population; ii) Label Reading; iii) modifying recipes to lower fat content; and iv) saturated versus unsaturated fats
Time frame: pre-, post and three month follow-up
Eating Habits: assessed using Eating Patterns Questionnaire, a 1993 revised version of Food Habits Questionnaire developed by Kristal, Shattuck & Henry
Time frame: pre-, post and three month follow-up
Attitudes about fat in diet
Cultural relevancy
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 15 Jan 2010.
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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.
Wendy F Auslander, PhD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eat Well Live Well Nutrition Program in people with Diabetes or Diabetes Prevention, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 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 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Weight & Body Mass Index (BMI) (time frame: pre-, post and three month follow-up). The study lists 2 primary outcomes in all. 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 15 Jan 2010.