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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)
Enrollment 26
Recruitment Details 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  
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
Period Title: Overall Study
Started 13 13
Completed 12 10
Not Completed 1 3
Reason Not Completed
Lack of Time             1             0
Medical Reason             0             1
Lost to Follow-up             0             2
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI) Total
Hide Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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 of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
42.5  (9.1) 43.8  (9.0) 43.1  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
11
  84.6%
11
  84.6%
22
  84.6%
Male
2
  15.4%
2
  15.4%
4
  15.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Change in Body Weight
Hide Description Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: kg
-5.6  (2.9) -3.1  (3.4)
2.Secondary Outcome
Title Change in Physical Activity
Hide Description A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: kcals/wk
983.3  (567.6) 776.3  (1194.8)
3.Secondary Outcome
Title Change in Dietary Intake: Kcals/Day
Hide Description A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: kcals/day
474.8  (509) 242.5  (709.3)
4.Secondary Outcome
Title Change in Dietary Intake: % Fat
Hide Description A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: percentage of fat intake
-3.26  (5.58) -0.00  (4.27)
5.Secondary Outcome
Title Change in Dietary Intake: % Protein
Hide Description A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: percentage of protein intake
0.73  (2.38) 0.44  (2.57)
6.Secondary Outcome
Title Change in Dietary Intake: % Carbohydrate
Hide Description A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: percentage of carbohydrate intake
0.64  (6.15) 0.90  (5.24)
7.Secondary Outcome
Title Completion of Self-monitoring of Dietary Intake and Physical Activity
Hide Description The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Overall Number of Units Analyzed
Type of Units Analyzed: Eating and Exercise Diary
143 143
Mean (Standard Deviation)
Unit of Measure: percentage of diaries completed
91.6  (18) 60.1  (38.5)
8.Secondary Outcome
Title Change in Weight Loss Self-efficacy
Hide Description Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.
Time Frame Week 0 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.3  (35.7) 16.3  (35.8)
9.Secondary Outcome
Title Autonomous and Controlled Motivation
Hide Description At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants’ reasons for continuing participation in a weight loss program via participants’ endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description:
Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
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.
Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Autonomous Motivation 6.3  (0.9) 5.3  (1.5)
Controlled Motivation 2.9  (1.1) 2.9  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Hide Arm/Group Description Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings. 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.
All-Cause Mortality
Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Behavioral Weight Loss Intervention (SBWL) Campaign Intervention (CI)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
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
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