Randomized Controlled Trial Targeting Obesity-related Behaviors

NCT ID: NCT01584102

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-09-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

Group Type: EXPERIMENTAL

group fitness + education

Intervention Type: BEHAVIORAL

15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education

Group 2

Group Type: ACTIVE_COMPARATOR

group fitness classes only

Intervention Type: BEHAVIORAL

15 weeks biweekly group fitness

Interventions

group fitness + education

15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education

Intervention Type: BEHAVIORAL

group fitness classes only

15 weeks biweekly group fitness

Intervention Type: BEHAVIORAL

Other Intervention Names

Eat Smart, Move More, Weigh Less

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jamie M Zoellner, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Tech

Blacksburg, Virginia, United States

Countries

United States

Other Identifiers

VTech-2012-1

Identifier Type: -

Identifier Source: org_study_id