ObesityNCT01584102
Randomized Controlled Trial Targeting Obesity-related Behaviors
A study testing group fitness + education and group fitness classes only in people with Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- group fitness + education and group fitness classes only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- <18 years of age
- Non-English-speaking
- Self-reported contraindications to exercise
- Blood pressure over 180/110 without medical clearance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Together Healthy Caswell County: Randomized Controlled Trial Targeting Obesity-related Behaviors
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.
Read the 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
- Being tested
- group fitness + education, group fitness classes only
- Keywords
- Randomized controlled trial, obesity, community-based participatory research, minority health, rural health, health promotion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group fitness + educationBehavioural
Also called Eat Smart, Move More, Weigh Less
15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education
group fitness classes onlyBehavioural
15 weeks biweekly group fitness
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Behavioral: group fitness + education |
| Group 2 | Active comparator | Not described Receives: Behavioral: group fitness classes only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jamie M Zoellner, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584102
- Sponsor's protocol ID
- VTech-2012-1
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2012
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Together Healthy Caswell County: Randomized Controlled Trial Targeting Obesity-related Behaviors
- ClinicalTrials.gov ID
- NCT01584102
- Acronym / sponsor ID
- VTech-2012-1
- Conditions
- Obesity
- Keywords
- Randomized controlled trial, obesity, community-based participatory research, minority health, rural health, health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: group fitness + education |
| Group 2 | Active comparator | Behavioral: group fitness classes only |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (4 listed)
- <18 years of age
- Non-English-speaking
- Self-reported contraindications to exercise
- Blood pressure over 180/110 without medical clearance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group fitness + educationAlso: Eat Smart, Move More, Weigh Less15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education | Behavioural | Group 1 |
| group fitness classes only15 weeks biweekly group fitness | Behavioural | Group 2 |
Primary outcome
Weight
Time frame: 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie M Zoellner, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group fitness + education and group fitness classes only in people with Obesity, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.