Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exercise: Improving Compliance and Long-term Weight Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Obesity Other: in-class yoga Other: yoga by DVD Other: stretching by DVD Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program
Study Start Date : February 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: in-class yoga
In-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour.

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.
Other: yoga by DVD
Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.

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.
Other: stretching by DVD
Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451800


Locations
Layout table for location information
United States, South Dakota
South Dakota State University
Brookings, South Dakota, United States, 57006
Sponsors and Collaborators
South Dakota State University
Investigators
Layout table for investigator information
Study Director: Bonny L Specker, PhD South Dakota State University

Layout table for additonal information
Responsible Party: South Dakota State University
ClinicalTrials.gov Identifier: NCT02451800     History of Changes
Other Study ID Numbers: 1411008
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms