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Considering Patient Diet Preferences to Optimize Weight Loss (Diet Choice)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01152359
First received: June 14, 2010
Last updated: October 17, 2014
Last verified: October 2014
Results First Received: October 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obesity
Interventions: Behavioral: Choice
Behavioral: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1 Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
Arm 2 Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.

Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     105     102  
COMPLETED     81     80  
NOT COMPLETED     24     22  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1 Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
Arm 2 Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  105     102     207  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 11     55  ± 10     55  ± 11  
Gender  
[units: participants]
     
Female     28     27     55  
Male     77     75     152  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     45     61     106  
White     54     39     93  
More than one race     0     0     0  
Unknown or Not Reported     6     2     8  
Region of Enrollment  
[units: participants]
     
United States     105     102     207  



  Outcome Measures

1.  Primary:   Body Weight   [ Time Frame: 48 weeks ]

2.  Secondary:   Diet Adherence as Measured by Block Food-frequency Questionnaire (Absolute Percentage Deviation From the Goal Macronutrient Intake--<30% Fat for Low-fat Diet or <10% Carbohydrate for Low-carbohydrate Diet)   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Obesity-specific Health-related Quality of Life as Measured by Impact Of Weight On Quality Of Life-Lite (IWQOL-Lite) Questionnaire   [ Time Frame: 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: William S. Yancy, Jr.
Organization: VA Medical Center
phone: 919-286-0411 ext 7770
e-mail: william.yancy2@va.gov


Publications of Results:
Other Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01152359     History of Changes
Other Study ID Numbers: IIR 09-381
Study First Received: June 14, 2010
Results First Received: October 17, 2014
Last Updated: October 17, 2014
Health Authority: United States: Federal Government