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Promoting Long-term Behavior Change to Reduce CVD Risk

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Unrestricted research gift from Nutrilite Health Institute
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00227006
First received: September 13, 2005
Last updated: January 19, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Promoting Long-term Dietary Change to Reduce CVD Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percentage of saturated fat in diet [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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
No Intervention: Community Access
Assessment-only control group
 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

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Stanford Prevention Research Center
ClinicalTrials.gov Identifier: NCT00227006     History of Changes
Other Study ID Numbers: R29-HL60154, R29HL060154
Study First Received: September 13, 2005
Last Updated: January 19, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013