Exercise: Improving Compliance and Long-term Weight Loss

Obesity Clinical Trial

Official title:

Exercise: Improving Compliance and Long-term Weight Loss With Sanford Profile Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02451800
• Other study ID #: 1411008
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: October 12, 2016
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: South Dakota State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• in-class yoga
In-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour.
• yoga by DVD
Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.
• stretching by DVD
Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.

Locations

Country	Name	City	State
United States	South Dakota State University	Brookings	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
South Dakota State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	All participants are enrolled in a weight loss program. This outcome will tell us whether yoga increases weight loss during the intervention.	3 months	No
Secondary	Weight loss	This outcome will tell us whether yoga participation results in long-term weight loss 3 months after the intervention stops.	6 months	No
Secondary	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.	3 months	No
Secondary	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.	6 months	No