Viewing Study NCT01584102


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Study NCT ID: NCT01584102
Status: COMPLETED
Last Update Posted: 2023-06-07
First Post: 2012-04-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Randomized Controlled Trial Targeting Obesity-related Behaviors
Sponsor: Virginia Polytechnic Institute and State University
Organization:

Study Overview

Official Title: Better Together Healthy Caswell County: Randomized Controlled Trial Targeting Obesity-related Behaviors
Status: COMPLETED
Status Verified Date: 2023-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: