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

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Behavioral Weight Loss Intervention (SBWL)
Campaign Intervention (CI)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Weight Loss, Physical Activity, Dietary Intake, Weight Loss Self-Efficacy, Motivation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh Physical Activity and Weight Management Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Behavioral Weight Loss Intervention (SBWL)

Campaign Intervention (CI)

Arm Description

Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.

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.

Outcomes

Primary Outcome Measures

Change in Body Weight
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
A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Change in Dietary Intake: Kcals/Day
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
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
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
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
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
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
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.

Full Information

First Posted
February 28, 2013
Last Updated
January 3, 2014
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01803737
Brief Title
Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults
Official Title
Feasibility of a Campaign Intervention Compared to a Standard Behavioral Weight Loss Intervention in Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Weight Loss, Physical Activity, Dietary Intake, Weight Loss Self-Efficacy, Motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Behavioral Weight Loss Intervention (SBWL)
Arm Type
Active Comparator
Arm Description
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Arm Title
Campaign Intervention (CI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavioral Weight Loss Intervention (SBWL)
Intervention Description
Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
Intervention Type
Behavioral
Intervention Name(s)
Campaign Intervention (CI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Weight
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
Secondary Outcome Measure Information:
Title
Change in Physical Activity
Description
A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Time Frame
Week 0 and 12
Title
Change in Dietary Intake: Kcals/Day
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
Title
Change in Dietary Intake: % Fat
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
Title
Change in Dietary Intake: % Protein
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
Title
Change in Dietary Intake: % Carbohydrate
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
Title
Completion of Self-monitoring of Dietary Intake and Physical Activity
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
Title
Change in Weight Loss Self-efficacy
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
Title
Autonomous and Controlled Motivation
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O Garcia, MS
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Physical Activity and Weight Management Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States

12. IPD Sharing Statement

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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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