ObesityNCT02451800
Exercise: Improving Compliance and Long-term Weight Loss
A study testing in-class yoga, yoga by DVD and stretching by DVD in people with Obesity, run by South Dakota State University at 1 site in United States.
Trial summary
The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- in-class yoga, yoga by DVD and stretching by DVD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be participants in the Sanford Profile Program (weight loss program)
Who cannot join
- Must have physician approval if answers yes to Physical Activity Readiness Questionnaire (PARQ) questions
Trial locations and contacts
1 site in 1 country.
United States1 site
South Dakota State University
Brookings, South Dakota, 57006
About this study
Official title: Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program
The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. Participants are randomized to one of three groups: in-class yoga, yoga by digital video disk (DVD), stretching by DVD. Changes in weight loss and stress levels are monitored.
Read the detailed description
The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. The 6-month study includes a 3-month randomized, controlled trial using in-person yoga, a yoga DVD, and a stretching DVD (control group) followed by a 3-month post-intervention follow-up. The study will be conducted to test the hypotheses that both in-person yoga classes and DVD yoga participation will result in 1) greater compliance with the Profile program, 2) greater weight loss during the yoga intervention, and 3) greater weight loss 3 months following completion of the intervention compared to the stretching intervention. Compliance will be investigated using percent of days that dietary intake was entered online and percent of days that online records indicate that the program was followed. Changes in weight will be measured using data transmitted from electronic scales that are provided as part of the Profile program. In order to assess weight change after participation in the intervention we will ask participants to continue weighing themselves daily for 3 months following completion of the intervention regardless of whether they completed the Profile program or not. Participants will complete online questionnaires on behavioral and appetite perceptions related to eating, food intake, stress levels, compliance with diet recommendations given to them by Sanford Profile, and perceived benefits of their intervention. We will use these measures to determine the effect of yoga participation on eating behaviors and stress levels.
- Conditions
- Obesity
- Being tested
- in-class yoga, yoga by DVD, stretching by DVD
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-class yogaOther
In-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour.
yoga by DVDOther
Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.
stretching by DVDOther
Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| in-class yoga | Experimental | The intervention is a in-class yoga course taught by yoga instructors for 3 times per week for 3 months. This class is based on "Peggy Cappy's Program: More Yoga for Every Body". Class is taught at Sanford Wellness Centers in Sioux Falls, South Dakota and Fargo, North Dakota. Each class in 1 hour in length. Receives: Other: in-class yoga |
| yoga by DVD | Active comparator | For the intervention participants are asked to do yoga at home following the "Peggy Cappy's Program: More Yoga for Every Body" DVD. They are asked to complete these exercises 3 times per week for 3 months. The DVD is 1 hour in length. Receives: Other: yoga by DVD |
| stretching by DVD | Active comparator | For the intervention participants are asked to do stretching exercises at home following "Bob Anderson's DVD-Stretching: the DVD". They are asked to complete these exercises 3 times per week for 3 months. The DVD is 1 hour in length. Receives: Other: stretching by DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
All participants are enrolled in a weight loss program. This outcome will tell us whether yoga increases weight loss during the intervention.
Measured: 3 months
Secondary outcomes (3)
Weight loss
This outcome will tell us whether yoga participation results in long-term weight loss 3 months after the intervention stops.
Measured: 6 months
Stress levels
Stress levels are measured using the Perceived Stress Scale (PSS). This outcome will tell us whether yoga participation reduces stress levels during intervention.
Measured: 3 months
Stress levels
Stress levels are measured using the Perceived Stress Scale (PSS). This outcome will tell us whether yoga participation has a long-term (3 mo) effect on reducing stress after intervention stops.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonny L Specker, PhD, Study director, South Dakota State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451800
- Sponsor's protocol ID
- 1411008
- Status last verified
- Oct 2016
- First submitted
- 30 Jan 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program
- ClinicalTrials.gov ID
- NCT02451800
- Acronym / sponsor ID
- 1411008
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 May 2015 (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 overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. Participants are randomized to one of three groups: in-class yoga, yoga by digital video disk (DVD), stretching by DVD. Changes in weight loss and stress levels are monitored.
Detailed description
The overall aim of the proposed study is to determine the effectiveness of a 3-month yoga program on increasing compliance and improving weight loss while participating in the Sanford Profile program. The 6-month study includes a 3-month randomized, controlled trial using in-person yoga, a yoga DVD, and a stretching DVD (control group) followed by a 3-month post-intervention follow-up. The study will be conducted to test the hypotheses that both in-person yoga classes and DVD yoga participation will result in 1) greater compliance with the Profile program, 2) greater weight loss during the yoga intervention, and 3) greater weight loss 3 months following completion of the intervention compared to the stretching intervention. Compliance will be investigated using percent of days that dietary intake was entered online and percent of days that online records indicate that the program was followed. Changes in weight will be measured using data transmitted from electronic scales that are provided as part of the Profile program. In order to assess weight change after participation in the intervention we will ask participants to continue weighing themselves daily for 3 months following completion of the intervention regardless of whether they completed the Profile program or not. Participants will complete online questionnaires on behavioral and appetite perceptions related to eating, food intake, stress levels, compliance with diet recommendations given to them by Sanford Profile, and perceived benefits of their intervention. We will use these measures to determine the effect of yoga participation on eating behaviors and stress levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| in-class yoga | Experimental | Other: in-class yogaThe intervention is a in-class yoga course taught by yoga instructors for 3 times per week for 3 months. This class is based on "Peggy Cappy's Program: More Yoga for Every Body". Class is taught at Sanford Wellness Centers in Sioux Falls, South Dakota and Fargo, North Dakota. Each class in 1 hour in length. |
| yoga by DVD | Active comparator | Other: yoga by DVDFor the intervention participants are asked to do yoga at home following the "Peggy Cappy's Program: More Yoga for Every Body" DVD. They are asked to complete these exercises 3 times per week for 3 months. The DVD is 1 hour in length. |
| stretching by DVD | Active comparator | Other: stretching by DVDFor the intervention participants are asked to do stretching exercises at home following "Bob Anderson's DVD-Stretching: the DVD". They are asked to complete these exercises 3 times per week for 3 months. The DVD is 1 hour in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be participants in the Sanford Profile Program (weight loss program)
Key exclusion criteria (1 listed)
- Must have physician approval if answers yes to Physical Activity Readiness Questionnaire (PARQ) questions
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 |
|---|---|---|
| in-class yogaIn-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour. | Other | in-class yoga |
| yoga by DVDIndividuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months. | Other | yoga by DVD |
| stretching by DVDIndividuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months. | Other | stretching by DVD |
Primary outcome
Weight loss
Time frame: 3 months
All participants are enrolled in a weight loss program. This outcome will tell us whether yoga increases weight loss during the intervention.
3 secondary outcomes
Weight loss
Time frame: 6 months
Stress levels
Time frame: 3 months
Stress levels
Time frame: 6 months
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 13 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Bonny L Specker, PhD study director
South Dakota 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 in-class yoga, yoga by DVD and stretching by DVD in people with Obesity, run by South Dakota 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 1 inclusion and 1 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 13 Oct 2016. 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 loss (time frame: 3 months). 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 13 Oct 2016.