ObesityNCT00227006
Promoting Long-term Behavior Change to Reduce CVD Risk
A study testing Behavioral lifestyle/weight-loss intervention in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term… Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral lifestyle/weight-loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Apr 2004
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physically inactive
- Able to participate in physical activity
- Percentage of daily calories from total fat 30% or more
- Free of diagnosed heart disease
- Stable on medications for 3 months or more Exclusion Criteria:- Diabetic
- Dysphoric (Beck Depression Inventory score greater than 18)
- Binge eating or bulimic (Eating Disorder Diagnostic Scale)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Promoting Long-term Dietary Change to Reduce CVD Risk
Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI).
Read the detailed description
Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI). Participants were randomized to Taste-Based Choices (taste-based goal setting + a standard 6-month behavioral weight-loss intervention), Smart Consumers (a standard 6-month intervention alone) or Community Access (access to commercial/community-based behavioral weight-loss programs) and followed over 18 months. To test our hypotheses, we examined a set of orthogonal contrasts (TBC and SC vs. CA; TBC vs. SC) on reductions in saturated fat (Block FFQ) and clinic-measured BMI.
- Conditions
- Obesity
- Being tested
- Behavioral lifestyle/weight-loss intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral lifestyle/weight-loss interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Taste-Based Goal Setting | Experimental | 6-month intervention (14 lifestyle counseling classes) Receives: Behavioral: Behavioral lifestyle/weight-loss intervention |
| Smart Consumers | Active comparator | 6-month intervention (14 lifestyle counseling classes) Receives: Behavioral: Behavioral lifestyle/weight-loss intervention |
| Community Access | Active comparator | Can enroll in behavioral treatment programs available in the community that do not include medication or very-low calorie diets Receives: Behavioral: Behavioral lifestyle/weight-loss intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of saturated fat in diet
Measured: 18 months
Secondary outcomes (1)
Body 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 posted27 Sep 2005 (estimated)
- Study startJan 1999
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Unrestricted research gift from Nutrilite Health Institute
- Responsible party
- Principal investigator, Michaela Kiernan, Stanford University
- Investigators
- Michaela Kiernan, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227006
- Sponsor's protocol ID
- R29HL060154
- Other IDs
- R29HL060154
- Status last verified
- May 2015
- First submitted
- 13 Sep 2005
- Last updated
- 20 May 2015
- Results posted
- No
Publications
Goldberg JH, Kiernan M. Innovative techniques to address retention in a behavioral weight-loss trial. Health Educ Res. 2005 Aug;20(4):439-47. doi: 10.1093/her/cyg139. Epub 2004 Dec 14.
PubMed 15598664Kraemer HC, Kiernan M, Essex M, Kupfer DJ. How and why criteria defining moderators and mediators differ between the Baron & Kenny and MacArthur approaches. Health Psychol. 2008 Mar;27(2S):S101-8. doi: 10.1037/0278-6133.27.2(Suppl.).S101.
PubMed 18377151
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Long-term Dietary Change to Reduce CVD Risk
- ClinicalTrials.gov ID
- NCT00227006
- Acronym / sponsor ID
- R29HL060154
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Unrestricted research gift from Nutrilite Health Institute
- Study start
- Jan 1999
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 27 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.
Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI).
Detailed description
Once intervention class or staff contact is removed, obese adults participating in behavioral weight-loss programs often give up healthy eating habits and regain weight. We examined whether taste-based goal setting, which minimizes perceived deprivation by promoting taste and moderation, would sustain long-term reductions in saturated fat and body mass index (BMI). Participants were randomized to Taste-Based Choices (taste-based goal setting + a standard 6-month behavioral weight-loss intervention), Smart Consumers (a standard 6-month intervention alone) or Community Access (access to commercial/community-based behavioral weight-loss programs) and followed over 18 months. To test our hypotheses, we examined a set of orthogonal contrasts (TBC and SC vs. CA; TBC vs. SC) on reductions in saturated fat (Block FFQ) and clinic-measured BMI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Taste-Based Goal Setting | Experimental | Behavioral: Behavioral lifestyle/weight-loss intervention6-month intervention (14 lifestyle counseling classes) |
| Smart Consumers | Active comparator | Behavioral: Behavioral lifestyle/weight-loss intervention6-month intervention (14 lifestyle counseling classes) |
| Community Access | Active comparator | Behavioral: Behavioral lifestyle/weight-loss interventionCan enroll in behavioral treatment programs available in the community that do not include medication or very-low calorie diets |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Physically inactive
- Able to participate in physical activity
- Percentage of daily calories from total fat 30% or more
- Free of diagnosed heart disease
- Stable on medications for 3 months or more Exclusion Criteria:- Diabetic
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 |
|---|---|---|
| Behavioral lifestyle/weight-loss intervention | Behavioural | Community Access, Smart Consumers, Taste-Based Goal Setting |
Primary outcome
Percentage of saturated fat in diet
Time frame: 18 months
1 secondary outcome
Body 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 20 May 2015.
- Background: PubMed 15598664Goldberg JH, Kiernan M. Innovative techniques to address retention in a behavioral weight-loss trial. Health Educ Res. 2005 Aug;20(4):439-47. doi: 10.1093/her/cyg139. Epub 2004 Dec 14.
- Background: PubMed 18377151Kraemer HC, Kiernan M, Essex M, Kupfer DJ. How and why criteria defining moderators and mediators differ between the Baron & Kenny and MacArthur approaches. Health Psychol. 2008 Mar;27(2S):S101-8. doi: 10.1037/0278-6133.27.2(Suppl.).S101.
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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.
Michaela Kiernan principal investigator
Stanford 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 Behavioral lifestyle/weight-loss intervention in people with Obesity, run by Stanford 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 7 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 20 May 2015. 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?
Percentage of saturated fat in diet (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 NCT00227006, which also lists 2 linked publications.
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 20 May 2015.