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Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults

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ClinicalTrials.gov Identifier: NCT01803737
Recruitment Status : Completed
First Posted : March 4, 2013
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
David Garcia, University of Pittsburgh

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Weight Loss
Interventions: Behavioral: Standard Behavioral Weight Loss Intervention (SBWL)
Behavioral: Campaign Intervention (CI)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We recruited twenty six (N=26) sedentary, overweight and obese adult men and women to participate in a behavioral weight loss intervention at the University of Pittsburgh Physical Activity and Weight Management Research Center. Recruitment occurred between January 2013 and March 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Behavioral Weight Loss Intervention (SBWL) Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Campaign Intervention (CI) Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.

Participant Flow:   Overall Study
    Standard Behavioral Weight Loss Intervention (SBWL)   Campaign Intervention (CI)
STARTED   13   13 
COMPLETED   12   10 
NOT COMPLETED   1   3 
Lack of Time                1                0 
Medical Reason                0                1 
Lost to Follow-up                0                2 



  Baseline Characteristics

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.
Statistical analyses were performed using the Statistical Package for the Social Sciences (IBM-SPSS, version 21.0). Statistical significance was accepted at the p<0.05 level of confidence. Analyses were conducted using individuals who completed assessments at week 0 and 12, with intent-to-treat (ITT) analysis carrying the baseline data forward.

Reporting Groups
  Description
Standard Behavioral Weight Loss Intervention (SBWL) Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Campaign Intervention (CI) Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
Total Total of all reporting groups

Baseline Measures
   Standard Behavioral Weight Loss Intervention (SBWL)   Campaign Intervention (CI)   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   13   26 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   13   26 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.5  (9.1)   43.8  (9.0)   43.1  (8.9) 
Gender 
[Units: Participants]
     
Female   11   11   22 
Male   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   13   13   26 


  Outcome Measures

1.  Primary:   Change in Body Weight   [ Time Frame: Week 0 and 12 ]

2.  Secondary:   Change in Physical Activity   [ Time Frame: Week 0 and 12 ]

3.  Secondary:   Change in Dietary Intake: Kcals/Day   [ Time Frame: Week 0 and 12 ]

4.  Secondary:   Change in Dietary Intake: % Fat   [ Time Frame: Week 0 and 12 ]

5.  Secondary:   Change in Dietary Intake: % Protein   [ Time Frame: Week 0 and 12 ]

6.  Secondary:   Change in Dietary Intake: % Carbohydrate   [ Time Frame: Week 0 and 12 ]

7.  Secondary:   Completion of Self-monitoring of Dietary Intake and Physical Activity   [ Time Frame: Week 0 and 12 ]

8.  Secondary:   Change in Weight Loss Self-efficacy   [ Time Frame: Week 0 and 12 ]

9.  Secondary:   Autonomous and Controlled Motivation   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David O. Garcia, PhD
Organization: University of Arizona
phone: 520-626-4641
e-mail: davidogarcia@email.arizona.edu


Publications:
United States Department of Health and Human Services. Dietary Guidelines for Americans, 2010. http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm. Accessed August 14, 2012.
United States Census Bureau. Computer and Internet Use. 2010 http://www.census.gov/hhes/computer/1. Accessed November 12, 2012.
Wing RR, Gillis B. The Diabetes Prevention Program's Lifestyle Change Program Appendix G: Toolbox. [DPP Lifestyle Change Program Manual of Operations]. 1996; 1-123. Available at: http://www.bsc.gwu.edu/dpp/lifestyle/apndxg.pdf.
Otto AD, Jakicic JM, Gallagher KI, Thomas EL, Mohr CR. Effect of an Incentive-Based Motivational Campaign on Weight Loss and Physical Activity in Overweight Women. Medicine & Science in Sports & Exercise. May 2004;36(5):S299-S300.
Otto AD, Jakicic JM. Examination of usefulness of time-based strategies on weight loss and physical activity in overweight adults [Abstract]. Obesity (Silver Spring). 2007;15(9:Supplement).
Canadian Society for Exercise Physiology. PAR-Q and You. 2002. http://www.csep.ca/cmfiles/publications/parq/par-q.pdf. Accessed August 14, 2012.
Borushek A. 2012 CalorieKing Calorie, Fat and Carbohydrate Counter: Costa Mesa, CA: Family Health Publications; 2012.


Responsible Party: David Garcia, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01803737     History of Changes
Other Study ID Numbers: PRO12110211
First Submitted: February 28, 2013
First Posted: March 4, 2013
Results First Submitted: November 4, 2013
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014