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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Garcia, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01803737
First received: February 28, 2013
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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 Intervention
Weight Loss
Behavioral: Standard Behavioral Weight Loss Intervention (SBWL)
Behavioral: Campaign Intervention (CI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.


Secondary Outcome Measures:
  • Change in Physical Activity [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    A questionnaire will be used to measure and quantify energy expenditure from physical activity.

  • Change in Dietary Intake: Kcals/Day [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  • Change in Dietary Intake: % Fat [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  • Change in Dietary Intake: % Protein [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  • Change in Dietary Intake: % Carbohydrate [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

  • Completion of Self-monitoring of Dietary Intake and Physical Activity [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    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.

  • Change in Weight Loss Self-efficacy [ Time Frame: Week 0 and 12 ] [ Designated as safety issue: No ]
    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.

  • Autonomous and Controlled Motivation [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803737

Locations
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
Principal Investigator: David O Garcia, MS University of Pittsburgh
  More Information

Publications:
Cohen SS, Signorello LB, Cope EL, et al. Obesity and All-Cause Mortality Among Black Adults and White Adults. American journal of epidemiology. Jul 20 2012.
Foster GD, Makris AP, Bailer BA. Behavioral treatment of obesity. Am J Clin Nutr. Jul 2005;82(1 Suppl):230S-235S.
Wing RR, Crane MM, Thomas JG, Kumar R, Weinberg B. Improving weight loss outcomes of community interventions by incorporating behavioral strategies. Am J Public Health. Dec 2010;100(12):2513-2519.
Finkelstein EA, DiBonaventura M, Burgess SM, Hale BC. The costs of obesity in the workplace. J Occup Environ Med. Oct 2010;52(10):971-976.

Responsible Party: David Garcia, Doctoral Student, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01803737     History of Changes
Other Study ID Numbers: PRO12110211
Study First Received: February 28, 2013
Results First Received: November 4, 2013
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Weight Loss
Physical Activity
Dietary Intake
Weight Loss Self-Efficacy
Motivation

Additional relevant MeSH terms:
Body Weight
Overweight
Weight Loss
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on October 01, 2014