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Promoting Long-term Behavior Change to Reduce CVD Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227006
First Posted: September 27, 2005
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Unrestricted research gift from Nutrilite Health Institute
Information provided by (Responsible Party):
Michaela Kiernan, Stanford University
  Purpose
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).

Condition Intervention
Obesity Behavioral: Behavioral lifestyle/weight-loss intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Long-term Dietary Change to Reduce CVD Risk

Resource links provided by NLM:


Further study details as provided by Michaela Kiernan, Stanford University:

Primary Outcome Measures:
  • Percentage of saturated fat in diet [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: 18 months ]

Enrollment: 163
Study Start Date: January 1999
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Taste-Based Goal Setting
6-month intervention (14 lifestyle counseling classes)
Behavioral: Behavioral lifestyle/weight-loss intervention
Active Comparator: Smart Consumers
6-month intervention (14 lifestyle counseling classes)
Behavioral: Behavioral lifestyle/weight-loss intervention
Active Comparator: Community Access
Can enroll in behavioral treatment programs available in the community that do not include medication or very-low calorie diets
Behavioral: Behavioral lifestyle/weight-loss intervention

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:- Body mass index between 27-37

  • 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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227006


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Unrestricted research gift from Nutrilite Health Institute
Investigators
Principal Investigator: Michaela Kiernan Stanford University
  More Information

Publications:
Responsible Party: Michaela Kiernan, Senior Research Scientist, Stanford University
ClinicalTrials.gov Identifier: NCT00227006     History of Changes
Obsolete Identifiers: NCT00005747
Other Study ID Numbers: R29HL060154 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 27, 2005
Last Update Posted: May 20, 2015
Last Verified: May 2015