Clinical trial NCT02451800: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: South Dakota State University
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight loss
timeFrame: 3 months
Secondary outcomes:
measure: Weight loss
timeFrame: 6 months
measure: Stress levels
timeFrame: 3 months
measure: Stress levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Bonny L Specker, PhD
role: STUDY_DIRECTOR
References: