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Exercise: Improving Compliance and Long-term Weight Loss

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ClinicalTrials.gov Identifier: NCT02451800
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
South Dakota State University

Tracking Information
First Submitted Date  ICMJE January 30, 2015
First Posted Date  ICMJE May 22, 2015
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02451800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • Weight loss [ Time Frame: 6 months ]
    This outcome will tell us whether yoga participation results in long-term weight loss 3 months after the intervention stops.
  • Stress levels [ Time Frame: 3 months ]
    Stress levels are measured using the Perceived Stress Scale (PSS). This outcome will tell us whether yoga participation reduces stress levels during intervention.
  • Stress levels [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise: Improving Compliance and Long-term Weight Loss
Official Title  ICMJE Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Other: in-class yoga
    In-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour.
  • Other: yoga by DVD
    Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.
  • Other: stretching by DVD
    Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.
Study Arms  ICMJE
  • Experimental: in-class yoga
    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.
    Intervention: Other: in-class yoga
  • Active Comparator: yoga by DVD
    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.
    Intervention: Other: yoga by DVD
  • Active Comparator: stretching by DVD
    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.
    Intervention: Other: stretching by DVD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2016)
162
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
225
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be participants in the Sanford Profile Program (weight loss program)

Exclusion Criteria:

  • Must have physician approval if answers yes to Physical Activity Readiness Questionnaire (PARQ) questions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02451800
Other Study ID Numbers  ICMJE 1411008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party South Dakota State University
Study Sponsor  ICMJE South Dakota State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bonny L Specker, PhD South Dakota State University
PRS Account South Dakota State University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP