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Exercise: Improving Compliance and Long-term Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
in-class yoga
yoga by DVD
stretching by DVD
Sponsored by
South Dakota State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Dakota State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

in-class yoga

yoga by DVD

stretching by DVD

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight loss
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

Weight loss
This outcome will tell us whether yoga participation results in long-term weight loss 3 months after the intervention stops.
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.
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.

Full Information

First Posted
January 30, 2015
Last Updated
October 12, 2016
Sponsor
South Dakota State University
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1. Study Identification

Unique Protocol Identification Number
NCT02451800
Brief Title
Exercise: Improving Compliance and Long-term Weight Loss
Official Title
Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Dakota State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
in-class yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
yoga by DVD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
stretching by DVD
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
in-class yoga
Intervention Description
In-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour.
Intervention Type
Other
Intervention Name(s)
yoga by DVD
Intervention Description
Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.
Intervention Type
Other
Intervention Name(s)
stretching by DVD
Intervention Description
Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.
Primary Outcome Measure Information:
Title
Weight loss
Description
All participants are enrolled in a weight loss program. This outcome will tell us whether yoga increases weight loss during the intervention.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight loss
Description
This outcome will tell us whether yoga participation results in long-term weight loss 3 months after the intervention stops.
Time Frame
6 months
Title
Stress levels
Description
Stress levels are measured using the Perceived Stress Scale (PSS). This outcome will tell us whether yoga participation reduces stress levels during intervention.
Time Frame
3 months
Title
Stress levels
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonny L Specker, PhD
Organizational Affiliation
South Dakota State University
Official's Role
Study Director
Facility Information:
Facility Name
South Dakota State University
City
Brookings
State/Province
South Dakota
ZIP/Postal Code
57006
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise: Improving Compliance and Long-term Weight Loss

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