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Randomized Controlled Trial Targeting Obesity-related Behaviors

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
group fitness + education
group fitness classes only
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Randomized controlled trial, obesity, community-based participatory research, minority health, rural health, health promotion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • >18 years of age,
  • English-speaking,
  • No self-reported contraindications to exercise
  • Eligible participants where scheduled an enrollment appointment. At this appointment, participants with blood pressure over 180/110 were directed to obtain immediate medical attention and were only eligible to enroll upon written consent from their physician

Exclusion Criteria:

  • <18 years of age
  • Non-English-speaking
  • Self-reported contraindications to exercise
  • Blood pressure over 180/110 without medical clearance

Sites / Locations

  • Virginia Tech

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

Weight

Secondary Outcome Measures

Full Information

First Posted
April 20, 2012
Last Updated
June 2, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT01584102
Brief Title
Randomized Controlled Trial Targeting Obesity-related Behaviors
Official Title
Better Together Healthy Caswell County: Randomized Controlled Trial Targeting Obesity-related Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The intervention included biweekly access to group fitness classes, with (Group 1) or without (Group 2) weekly nutrition and physical activity education sessions. Outcome measures were assessed at baseline and immediately post intervention and included BMI, waist circumference, blood pressure, physical activity and dietary behaviors, and psychosocial variables.
Detailed Description
This 15-week randomized controlled pilot study consisted of two groups. All participants received access to two group fitness classes per week, which were offered free of charge at the Caswell County Parks and Recreation Building. Zumba classes were offered one night a week, and the other evening was a 'potluck night' designed to increase participants exposure to a variety of other fitness classes such as floor aerobics, kickboxing, line dancing, and African dancing. Participants in the intervention group (Group 1) were enrolled in Eat Smart, Move More, Weigh Less (ESMMWL) where they received on hour weekly education classes on healthy eating and physical activity. The ESMMWL curriculum is a 15-week weight-management program that is delivered by local educators. Published research data were used to identify strategies that would lead to weight loss and/or weight maintenance. The program uses the Theory of Planned Behavior, and as such informs, empowers, and motivates participants to live mindfully as they make choices about eating and physical activity. The program provides opportunities for participants to keep a journal of healthy eating and physical activity behaviors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Randomized controlled trial, obesity, community-based participatory research, minority health, rural health, health promotion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
group fitness + education
Other Intervention Name(s)
Eat Smart, Move More, Weigh Less
Intervention Description
15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education
Intervention Type
Behavioral
Intervention Name(s)
group fitness classes only
Intervention Description
15 weeks biweekly group fitness
Primary Outcome Measure Information:
Title
Weight
Time Frame
15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: >18 years of age, English-speaking, No self-reported contraindications to exercise Eligible participants where scheduled an enrollment appointment. At this appointment, participants with blood pressure over 180/110 were directed to obtain immediate medical attention and were only eligible to enroll upon written consent from their physician Exclusion Criteria: <18 years of age Non-English-speaking Self-reported contraindications to exercise Blood pressure over 180/110 without medical clearance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie M Zoellner, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Tech
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States

12. IPD Sharing Statement

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Randomized Controlled Trial Targeting Obesity-related Behaviors

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