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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 Description
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Brief Summary:
The purpose of this study is to examine the feasibility of a campaign intervention for weight management compared to a standard behavioral weight loss intervention in overweight and obese adults.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Standard Behavioral Weight Loss Intervention (SBWL) Behavioral: Campaign Intervention (CI) Not Applicable

Detailed Description:
The feasibility of solely using a campaign intervention (CI) to promote healthy eating and physical activity behaviors for weight loss and weight maintenance has not been examined in a systematic manner. Thus, the primary aim of this study will be to examine whether a stand-alone CI results in similar weight loss compared to a standard behavioral weight loss intervention (SBWL). It is hypothesized that the CI will achieve a similar weight loss when compared to the SBWL. Additional aims include the examination of the CI on changes in moderate to vigorous intensity physical activity, dietary intake, self-monitoring of dietary intake and physical activity, weight loss self-efficacy, and motivation compared to a SBWL. This study will recruit forty-eight 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 (PAWMRC). To be considered eligible for this study, participants must be 18-55 years of age, with a Body Mass Index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m². Assessments will be conducted at week 0 and 12 of the intervention. Each assessment will take approximately 30 minutes to complete and include height, body weight, and assessment of physical activity, dietary intake, weight loss self-efficacy, and motivation. Upon successful completion of baseline assessments, eligible subjects will be randomly assigned to one of two groups using a stratified randomized block design: 1) standard behavioral weight loss intervention (SBWL) or 2) campaign intervention (CI). The CI will target specific diet and physical activity behaviors to improve weight loss efforts within a thematic framework based on the professional auto racing point system concept. CI session content and targeted behavior goals will tie into this overall theme and throughout the campaign participants will have the opportunity to earn incentives to reinforce positive behavior changes. This study is a necessary first step to examine the feasibility of a stand-alone campaign as an alternative strategy for weight management when compared to a standard behavioral weight loss intervention. Furthermore, this study will provide variance estimates on the effectiveness of a campaign intervention compared to a standard behavioral weight loss program that can be used to determine appropriate sample sizes for a future full-scale clinical study of this alternative strategy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults
Study Start Date : January 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Behavioral Weight Loss Intervention (SBWL)
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
 Behavioral: Standard Behavioral Weight Loss Intervention (SBWL)
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Experimental: Campaign Intervention (CI)
Included 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.
 Behavioral: Campaign Intervention (CI)
Included 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Body Weight [ Time Frame: Week 0 and 12 ]
    Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.


Secondary Outcome Measures :
  1. Change in Physical Activity [ Time Frame: Week 0 and 12 ]
    A questionnaire will be used to measure and quantify energy expenditure from physical activity.

  2. Change in Dietary Intake: Kcals/Day [ Time Frame: Week 0 and 12 ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  3. Change in Dietary Intake: % Fat [ Time Frame: Week 0 and 12 ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  4. Change in Dietary Intake: % Protein [ Time Frame: Week 0 and 12 ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  5. Change in Dietary Intake: % Carbohydrate [ Time Frame: Week 0 and 12 ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

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

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-55 years of age
  • Body mass index (BMI) ranging from ≥25.0 kg/m² to 45.0 kg/m²
  • Ability to provide informed consent

Exclusion Criteria:

  • Regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months.
  • Participation in a previous physical activity or weight management research project in the previous 6 months.
  • Weight loss of ≥5% of current body weight in the previous 6 months.
  • For women, those currently pregnant, pregnant during the previous 6 months, or plan on becoming pregnant in the next 6 months.
  • History of myocardial infarction, coronary bypass surgery, angioplasty, or other heart-related surgeries.
  • History of orthopedic or physical complications that would prevent participation in exercise.
  • Currently taking any prescription medication that may affect metabolism and/or body weight (e.g., synthroid).
  • Currently being treated for any condition that could affect body weight, such as coronary heart disease, diabetes mellitus, uncontrolled hypertension, cancer, depression, and anxiety.
  • Currently being treated for any psychological issues or problems, taking any psychotropic medications, or receiving treatment with psychotropic medications within the previous 6 months.
  • Resting systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg. Subjects with controlled hypertension will be allowed to participate if they obtain a medical doctor's written consent to ensure that it is safe to participate in a weight loss intervention.
  • Currently do not have access to a computer and the Internet.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803737


Locations
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United States, Pennsylvania
University of Pittsburgh Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, United States, 15217
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: David O Garcia, MS University of Pittsburgh
More Information
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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.

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Responsible Party: David Garcia, Doctoral Student, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01803737    
Other Study ID Numbers: PRO12110211
First Posted: March 4, 2013    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014
Last Verified: January 2014
Keywords provided by David Garcia, University of Pittsburgh:
Weight Loss
Physical Activity
Dietary Intake
Weight Loss Self-Efficacy
Motivation
Additional relevant MeSH terms:
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Body Weight
Overweight
Weight Loss
Body Weight Changes