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



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:3/1/2014
Start Date:January 2013
End Date:June 2013

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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.

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.

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.
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