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

January 3, 2014 updated by: David Garcia, University of Pittsburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15217
        • University of Pittsburgh Physical Activity and Weight Management Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity
Time Frame: Week 0 and 12
A questionnaire will be used to measure and quantify energy expenditure from physical activity.
Week 0 and 12
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.
Week 0 and 12
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.
Week 0 and 12
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.
Week 0 and 12
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.
Week 0 and 12
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.
Week 0 and 12
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.
Week 0 and 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: David O Garcia, MS, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO12110211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Loss

Clinical Trials on Standard Behavioral Weight Loss Intervention (SBWL)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe