Promoting Long-term Behavior Change to Reduce CVD Risk

May 18, 2015 updated by: Michaela Kiernan, Stanford University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of saturated fat in diet
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Unrestricted research gift from Nutrilite Health Institute

Investigators

  • Principal Investigator: Michaela Kiernan, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • R29HL060154 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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